“The WIRB‐Copernicus Group is pleased that Dr. Cooper and Dr. Fisher have been invited to speak at the AAHRPP Conference, and we are proud to support AAHRPP in its mission to promote high‐quality research and strengthen human research protection programs through accreditation,” said Stuart Horowitz, PhD, MBA, President of Institutions and Institutional Services for The WIRB‐Copernicus Group. “The WIRB‐ Copernicus Group brings more expertise to the industry than any other ethical solutions provider, and through its Consulting and Technology Divisions, is uniquely poised to support institutional clients in achieving the goal of AAHRPP accreditation.”

Dr. Cooper is one of the founders of AAHRPP and was responsible for the development and operation of its accreditation process from 2002 to 2009. In his capacity within the Consulting Division of The WIRB‐ Copernicus Group, Dr. Cooper works with a team of former AAHRPP accreditors and site visitors, as well as current AAHRPP council members, to provide expert guidance to institutions considering AAHRPP accreditation, or undergoing the accreditation or reaccreditation process.

At the upcoming AAHRPP conference, Dr. Cooper will moderate a luncheon session entitled, “The Flexible IRB,” during which he will lead the Flexibility Coalition in an informal discussion regarding overlooked opportunities for flexibility within the ethical review process. The majority of Dr. Cooper’s recommendations can be accomplished without going outside of regulatory requirements, and with HHS‐ funded research, which represents an innovative step forward for the industry.

Dr. Cooper will be joined on the AAHRPP speaking faculty by Dr. Fisher, who oversees Process Development and Training at WIRB (a WIRB‐Copernicus Group Company). Dr. Fisher will discuss the globalization of clinical trials and the increasingly common practice of inter‐reliance among institutional IRBs, prompted by the growth of multisite studies and the Office of Human Research Protections’ (OHRP) shift from favoring local review. During her presentation, “Reviewing Multisite Research Conducted in Other Countries,” Dr. Fisher will address the scope of globalization and its contributing factors, and provide concrete recommendations for the review of international multisite research, including an outline of important considerations for the reviewing IRB.

Dr. Cooper has 25 years of experience in the field of human research subject protection and oversees consulting and outsourcing services to institutions conducting or managing human research. A medical doctor, he is an accomplished basic and clinical investigator and an experienced IRB chair and director.

Dr. Fisher is responsible for WIRB’s International Fellows Program and Canadian Office, and oversees the coordination of over 100 Board Members. A psychologist by training, Dr. Fisher is an experienced IRB director and has over 25 years of experience working in academic medical centers in clinical and research settings.

The theme of this year’s AAHRPP conference is “Quality Human Research Protection Programs: Evidence‐ Based Practice in a Global Environment.” Researchers, organizational officials, HRPP professionals, IRB members and chairs, sponsors, and others interested in global standards for human research protection are invited to attend. For more information, please contact the AAHRPP organization directly, or visit http://aahrpp.org/grow.

About The WIRB‐Copernicus Group
Transforming Ethical Review

The WIRB‐Copernicus Group (WCG) is the world’s largest provider of regulatory and ethical review services for human research. With eight individual AAHRPP accredited panels, over 100 experienced board members, and over 60 years of combined experience in protocol and study‐related review, The WIRB‐Copernicus Group brings more expertise to the industry than any other ethical solutions provider.

Members of The WIRB‐Copernicus Group family of companies include Western Institutional Review Board (WIRB) and Copernicus Group IRB (CGIRB), the nation’s leading independent institutional review boards, and IRBNet, the top research compliance software supporting institutions. It is the mission of The WIRB‐ Copernicus Group to meet the highest standards of ethics and science, and to ensure the safety andwelfare of research subjects worldwide.

For more information, please visit www.wcgirb.com.

The final rankings will be announced during Training’s 2012 Conference and Expo, scheduled for Feb. 18-20 in Orlando, Florida.

Training determines its Top 125 rankings using benchmark statistics and by evaluating corporate commitment, formal training programs, program efficacy and innovation.  In addition to Copernicus Group IRB, other finalists include such powerhouse brands as Dell Inc., EMC Corporation, EMD Serono, Inc., Novo Nordisk Inc., PPD, Sprint, United States Navy, Intel Corp., UPS and Verizon.

“The distinction of being selected as a finalist for the Training Top 125 is further evidence of our ongoing commitment to training and retaining the most skilled IRB professionals in the industry”, CGIRB Chief Operating Officer Dawn Pope said.  “The protection of human research subjects demands we maintain the highest training standards.  Better staff education leads to increased employee competence, overall experience levels and, ultimately, improved service and impeccable quality for our clients.”

CGIRB’s corporate trainer, Sydney Douglas, manages the training program which includes new employee orientation, skill development, interdepartmental trainings, accreditation/certification programs and coordination of corporate training initiatives.

The resulting training-focused environment enables new employees to quickly acclimate and contribute to the corporate culture, while ensuring seasoned staffers remain at the forefront of the industry.

“This award not only validates the efficacy of our training program, but also encourages innovation in our training methods and aids in the development of our annual training goals,” Douglas said. “At CGIRB, we fully realize that the quality of service we provide for our clients is directly related to the quality of training we provide for our staff.  Training has always been a part of our culture, and we are thrilled to receive this honor.”

In addition to this role, Higgins will also serve as faculty and will help to lead two sessions. These include:

• Wednesday, Dec. 5 2:15 p.m. – 3:30 p.m.
  How to Grow Your IRB Career: Professional Development and Networking
  During this session, Higgins, along with other PRIM&R faculty, will offer practical advice about education and mentoring opportunities for IRB professionals and discuss how to develop a network of trusted advisors. Faculty will also discuss the role of the IRB professional in serving the HRPP community on local, regional and national levels.
• Thursday, Dec. 6 3:30 p.m. – 4:45 p.m.
  Ask the Experts! Everything You Wanted to Know, but Were Afraid to Ask
  Designed for those new to the field of research ethics, this session is led by experienced veterans and PRIM&R pros, including Higgins, who aim to answer questions newcomers to the field have, but are often afraid to ask. Faculty will address concerns to share with the group in an open, interactive and lively discussion with faculty and peers.

The annual Advancing Ethical Research Conference serves those involved in every facet of the research arena. The 2012 conference will bring together nearly 3,000 individuals from hospitals, universities and other research institutions, the federal government and industry. A series of 18 informational and inspirational plenary sessions will be offered, as well as participation in 150 practical workshops and didactic sessions. For more information on the conference, visit http://www.primr.org/aer12/.

The annual Advancing Ethical Research Conference serves those involved in every facet of the research arena. The 2012 conference will bring together nearly 3,000 individuals from hospitals, universities and other research institutions, the federal government and industry. A series of 18 informational and inspirational plenary sessions will be offered, as well as participation in 150 practical workshops and didactic sessions.

Through his 25 years of experience in the field of human research subject protection, Cooper has greatly enhanced IRB efficiency while maintaining compliance and effectiveness. As an expert in international laws and standards to human research, Cooper will be participating in three different sessions during the conference, including:

• Monday, Dec. 3 8:30 a.m. -4:45 p.m.
  IRB 301: Review and Application of the Regulatory Criteria for Approval
  In this exclusive session, Cooper will help attendees understand how to apply the criteria for IRB approval of research and provide the knowledge on how to guide the IRB in the application of the criteria for IRB approval.

• Tuesday, Dec. 4 10:30 a.m. – 11:45 a.m.
  A9 Advanced: To Waive or not to Waive? That Is the Question
  During this session, Cooper will discuss the appropriate use of waivers. Attendees will review the regulatory applicability of waivers and explore a variety of cases in which a waiver would add more protections and help facilitate research.

• Tuesday, Dec. 4 3:45 p.m.–5:00 p.m.
  B12 Basic: Is It Human Research? Is It Exempt? Determining When an Activity Must Undergo IRB Review
  As a co-facilitator and expert in the DHHS and FDA regulations, Cooper will provide attendees with the opportunity to become more familiar with the two distinct definitions of human subjects research found in the DHHS and FDA regulations. Attendees will also be able to discuss the differences between DHHS and FDA regulations regarding exempt research categories.

For more information on the conference, visit http://www.primr.org/aer12/.

Dawn Pope, CGIRB’s Chief Operating Officer, accepted the award at the 20th Annual Fast 50 Awards held November 15 at the Sheraton Imperial Hotel & Convention Center in Durham, NC. CGIRB , the only IRB to be recognized, was among a group of leading life sciences organizations including INC Research LLC, Drug Safety Alliance, Clinipace and Novella Clinical.

The Fast 50 winners were selected and ranked based on a formula that counts revenue growth and profitability in the preceding three years (2009-2011) and are recognized for entrepreneurial excellence and achievement.

“Our clients recognize our commitment to our mission of protecting human subjects participating in clinical trials. They appreciate that we are able to carry out this serious responsibility while at the same time providing quality customer service and industry leading technology. The combination of mission focus and superior customer service is what helped us to achieve this distinction,” said Ms. Pope. “Delighting our clients is one of the primary reasons we are a successful business. Next year, we’ll continue to focus on expanding our new client base through strategic relationships and by continuing to offer unparalleled customer service and industry leading technology.”

For more information on the 20th Annual Fast 50 Award and for a full list of honorees, click here.

About Copernicus Group IRB
Experience and innovation in ethical review®
Copernicus Group IRB, established in July 1996, is a leading U.S. independent institutional review board (“IRB”) dedicated to ensuring the rights and welfare of research study participants. The IRB provides ethical review of research protocols, investigators, and subject information and consent forms to ensure compliance with federal regulations set forth in 21 CFR, 45 CFR and ICH/GCP Guidelines. CGIRB achieved full AAHRPP accreditation in 2004, reaccreditation in 2007 and 2011, and ISO 9001:2008 certification in 2010. For more information please visit http://www.cgirb.com.

About Triangle Business Journal
Triangle Business Journal, a multimedia platform for business news and the publisher of a weekly business newspaper, is the leading provider of local business news for the Triangle, N.C. area. TBJ also hosts recognized, sold-out events such as Fast 50, Women in Business, 40 under 40 and others. Click on trianglebusinessjournal.com and register for free Daily Email Updates today.

Slack discusses the promotion of human protection in drug research on a global scale. Much of the article is focused on the need for uniform standards and summarizes the discussions that took place during the conference “Creating a Global Clinical Trial Platform: Partnering for Synergy” DIA and Duke hosted in collaboration with CGIRB in May 2012.

To preview the article published in the November 2012 issue of SRA, click here. Subscribers can access the full article at www.rajpharma.com.

The conference, which will be held at the Hilton San Diego Bayfront, will include more than 90 sessions and workshops in seven tracks: sponsor operations, site operations, regulatory compliance, contracts, budgets & billing, quality and special topics.

Industry leaders from groups like Celgene, Duke Clinical Research Institute and the Food and Drug Administration will present on topics ranging from Budget Analysis to Inspections of Research Sites. Nick Slack, Vice President for Consulting and Business Development at Western IRB, CGIRB’s sister company, will present on re-thinking the current state of IRB review.

Will you be attending MAGI West? Contact CGIRB or call 888-303-2224 to schedule a meeting at the conference.

As seen in Applied Clinical Trials 

Consistent, effective process improvement can be the key to reducing delays and improving data accuracy. 

In clinical trials, turnaround time and data accuracy are critical. The cost of a one-day delay in a drug being brought to market can be as much as $4 million-$5 million.(1) Likewise, paperwork-based errors in the clinical trial process – whether they occur at the sponsor level, the contract research organization (CRO) level or the institutional review board (IRB) level – can have serious downstream effects, negatively impacting study efficacy and time-to-market.

It is essential, therefore, that all participants in clinical trials – sponsors, CROs and IRBs – take steps to improve both efficiency and accuracy. Doing so requires that organizations look beyond symptoms to uncover the true causes of delays and errors. The holistic, rather than granular, application of positive change allows for maximum effect and return on investment (ROI). Additionally, new processes must be implemented in such a way as to become part of institutional culture, ensuring the consistent, ongoing success of future efforts.

In order to address these concerns, several successful organizations associated with the clinical trial industry have begun implementing Lean Six Sigma principles. Developed in the early 2000s by Michael George, now the Director of the Institute of Business Entropy(2), Lean Six Sigma is a combination of two distinct ongoing business improvement practices, Lean and Six Sigma.

The former, Lean, is a system designed to “maximize customer value while minimizing waste,” according to the Lean Enterprise Institute (LEI).(3) Lean focuses on eliminating waste along entire value streams, creating “processes that need less human effort, less space, less capital, and less time to make products and services at far less costs and with much fewer defects, compared with traditional business systems. Companies are able to respond to changing customer desires with high variety, high quality, low cost, and with very fast throughput times. Also, information management becomes much simpler and more accurate.”(4) Positive changes are created through the use of Kaizen Events – focused, multi-day initiatives designed to deliver sustainable, continuous improvement and lasting cultural change.

Six Sigma, meanwhile, “is a disciplined, data-driven approach and methodology for eliminating defects (driving toward six standard deviations between the mean and the nearest specification limit) in any process.”(5) To be in compliance with Six Sigma goals, the rate of defects – anything outside of customer specifications – must be limited to 3.4 per 1 million opportunities. This is a perfection rate of 99.99966 percent, often referred to as 3.4 DPMO (or 3.4 defects per million opportunities).(6)

Lean Six Sigma strives to combine the best of Lean and Six Sigma methodologies. Data-driven decision-making in the Six Sigma vein uncovers the root of problems, Lean principles are used to improve productivity and Kaizen Events are implemented to create rapid, lasting change. “The resulting one-two punch becomes a formidable tool for attacking the problems that enlarge the difference between annual revenues and the bottom line,” wrote Bonnie Smith in ‘Quality Progress,’ the flagship publication of the American Society for Quality. “The two initiatives work together, achieving results consistently superior to what either system could achieve alone. It’s a classic case of the whole being greater than the sum of the parts.”(7)

Classically, Lean and Six Sigma principles were applied primarily to manufacturing situations, with eyes on eliminating wasted raw materials and scrapped pieces. However, both methodologies – and the consequent Lean Six Sigma methodology – apply equally well to academic and service-oriented pursuits, such as the conduct of clinical trials. By seeking the true root of issues, sponsors, CROs and IRBs are able to address study and review delays and paperwork-based errors, improving time-to-market and overall accuracy. The result is studies that are completed more quickly, more profitably and with the best possible ethical oversight, protecting the rights of human subjects and vulnerable populations.

In this paper, we address the use of Lean Six Sigma principles in the clinical trial industry by taking two distinct perspectives. The first is that of Copernicus Group IRB, a North Carolina-based review board that has improved turnaround time and reduced errors by implementing CLASS – the Copernicus Lean And Six Sigma initiative. Included is input from Steve Laton, a lean improvement specialist at North Carolina State University’s Industrial Extension Service who assisted Copernicus Group IRB in establishing CLASS. The second explores Lean Six Sigma at major clinical trial sponsors, including input from Lean Six Sigma Green Belt Soo Bang, who oversaw a continuous process improvement program at Pfizer.

Lean Six Sigma at the IRB level

Copernicus Group IRB (CGIRB) is an independent institutional review board established in July 1996, whose primary responsibility is to ensure that the rights and welfare of human research subjects are protected. The CGIRB board reviews research protocols and study-related information, as well as investigator qualifications and resources to ensure regulatory compliance.

CGIRB has a long-standing tradition of meeting or exceeding the standards for industry certifications. In 2004, the Research Triangle Park, N.C., company became one of the first organizations to be awarded full accreditation of the human research protection program by AAHRPP, the Association for the Accreditation of Human Research Protection Programs, Inc., and was awarded full reaccreditation in 2007 and 2011.

CGIRB has long focused on process improvements. The company affirmed its commitment to quality management in May 2010, when it became the first IRB to receive ISO 9001:2008 certification. After performing the intense internal audits required by ISO, CGIRB began looking at methods for reducing waste and limiting non-value-added activities, with eyes on improving response time and achieving 100 percent data accuracy in every submission. The exploration of numerous process improvement systems and methodologies led the company to embark upon a Lean Six Sigma program in partnership with North Carolina State University’s Industrial Extension Service (IES).

The goal of the Copernicus Lean and Six Sigma (CLASS) initiative was the minimization of non-value added activities and the reduction of variation – eliminating rework, reducing costs and improving customer satisfaction, both internal and external. This is achieved through an employee team-based approach, led by a facilitator, which promotes employee empowerment and positive morale. Success is determined by measuring internal and external errors, client feedback and employee involvement. Surveys, metrics review and error Sigma rates are routinely analyzed to measure the effectiveness of improvements.

Implementing CLASS

Lean Six Sigma-style process improvement at CGIRB began with the formation of a management steering committee to map out a strategic plan and goals for the effort. Cross-functional teams and project leaders/point-people were chosen from CGIRB’s pool of employee volunteers and subject matter experts to carry out the chosen method of process improvement – a 10-step process coupled with Kaizen Events. The CLASS Kaizen Events were based on value-stream mapping (the targeting of waste within a process or workflow for reduction or deletion). The cross-functional teams comprised a combination of process owners and “internal suppliers” who fed data into the process. This allowed for both sufficient institutional knowledge on the processes being modified and “fresh eyes” to suggest additional possibilities for the removal of waste and non-value-add activities.

Reducing turnaround time for amendments

After establishing the baselines for the CLASS initiative, CGIRB embarked on the first of three Kaizen Events. The first event was designed to improve turnaround time and reduce the (already low) number of errors during the review of an amendment submission. CGIRB’s Kaizen Events begin with a process workflow being examined from start to finish. From there, the workflow is broken down into steps, and the time it takes to complete each step is noted. Wasted time between steps is accounted for, and an ideal version of the workflow – one with less non-value-add time – is mapped out. Tools are identified allowing CGIRB team members to realistically and sustainably reach the idealized workflow, and the improved process goes into production. In the case of amendments, a quality control (QC) checklist was added to CGIRB’s routing cover sheet to simplify internal submission processing. This change alone resulted in an immediate decrease in turnaround time and errors. Based on continuous monitoring and user feedback, the QC checklist was moved from the routing cover sheet to a submission comments area within the document workflow, further improving adherence to best practices and decreasing processing steps. The final result was a 20 percent reduction in turnaround time on one of the most involved submission types generally handled by IRBs.

Improving shipping times

CGIRB’s second Kaizen Event, undertaken in October 2011, involved the streamlining of workflows within the company’s document shipping area. A number of non-value-added areas were identified within the department, including the shipping area being split between separate rooms and the use of separate computers for shipping study documentation via FedEx, UPS and the U.S. Postal Service. As a result of the Kaizen Event, CGIRB consolidated the shipping department to a single room, improving communication between staff members and enhancing staff collaboration. CGIRB also implemented a best-in-breed Pitney Bowes automated shipping system, vastly reducing technological redundancies within the department and cutting the time needed to deliver documents to clients.

Error reduction

Ongoing at the time of this writing was CGIRB’s third Kaizen Event, focusing on corrections. The process involved the identification of the root cause of the company’s top five most frequent errors and the creation of a streamlined QC process within the correction workflow. The goal is to further improve review turnaround time while maintaining quality and regulatory standards.

A cultural shift

A cultural shift toward constant collaboration and continuous process improvements has been inherent in CGIRB’s Lean Six Sigma program. Departmental goals  have been further aligned with CGIRB’s mission, vision and values and an increasing number of facilitators have been empowered over time. Likewise, daily accountability is promoted, in three key ways:

• An operational dashboard, allowing all team members to access visual reports of progress on goals established in Kaizen Events.
• An enhanced correction database, increasing efficiency and reducing redundancy based on survey results. Internal/external errors are captured to identify any training trends, and organizational goals are set each year.
• Metrics on data accuracy and the reduction of clinical trial cycle time.

The results of CGIRB’s CLASS initiative have been striking. The turnaround time for certain specific submission types have been reduced by an average of 20 percent, with a marked decrease in errors. Review standards have been maintained, meeting CGIRB’s ultimate priority of the protection of human subjects and vulnerable populations.

“The CLASS initiative promotes collaboration across teams, giving team members the opportunity get to know colleagues in other departments,” said CLASS project facilitator and CGIRB Assistant Director for Project Management Sherry Seabock. “All team members agree to work toward an improved process with an open mind, speak with data and encourage a ‘please try’ attitude with mutual respect for all.”(8)

Lean Six Sigma at the sponsor level

Lean Six Sigma methodology has also proved effective at the sponsor level. Soo Bang, an active clinical research professional, led a 2010 initiative at Pfizer focused on the improvement of academic medical center contract cycle time through the use of Lean Six Sigma methodology.

Like all Lean Six Sigma projects, the initiative began with a data-based discovery process that challenged the original hypothesis on the cause of delays when working with academic medical centers. In the case of the 2010 effort, it was assumed that the high percentage of oncology studies within the pool of contracts with academic medical centers was resulting in a slower average study time, due to the complicated nature of oncology research. However, statistical analysis showed that oncology studies were not causing undue slowdowns.

Armed with this information, empowered team members and CRO staffers embarked on a value-stream mapping exercise, ultimately identifying three potential causes for delays. Three potential methods of improvement were then put into place:

• The use of new agreements, rather than reuse of previously negotiated ones, allowed for increased flexibility and nimbleness.
• The sponsor’s internal ability to quickly understand and respond to CRO concerns was increased.
• Clear communication plans were established, allowing CROs to efficiently escalate issues to sponsors. This effort allowed the sponsor to react and respond in a timely fashion.

The results

As a result of the Lean Six Sigma initiative, contract cycle times when dealing with academic medical centers were cut by more than 50 percent. The improved cycle times provided opportunity for rapid site activation and opportunity for clinical trial performance on par with non-academic sites that typically operate under shorter contract cycle times.

The Lean Six Sigma approach was integral to the success. Because of its inherent focus on addressing the root causes of problems and delays, the methodology allowed the sponsor to create real, lasting, sustainable change, improving profitability and positively affecting patient outcomes, rather than simply handling downstream symptoms.

“There are so many tools within Lean Six Sigma training that make you think about things differently,” Bang said. “One of the major principles of Lean Six Sigma is value-add and non-value-add activities. A lot of what we do as sponsors, CROs and IRBs every day are non-value-add activities. If organizations are thinking about eliminating those, they are able to instill a culture of productivity. In that situation, quality comes from the design of the process, rather than blaming it on people.”(9)

Conclusion

As proven by the result of initiatives at Copernicus Group IRB and a leading sponsor (which conducted its effort in conjunction with multiple CROs), Lean Six Sigma methodology is a valuable tool for organizations within the clinical trial industry. Because of its data-driven decision-making, sustainable change, positive cultural shifts and emphasis on discovering the root cause of issues, such a process is tailor-made for the field. When deployed properly, Lean Six Sigma initiatives can allow sponsors, CROs and IRBs to reduce both study times and error rates. This, in turn, creates studies that are more profitable and bring life-saving pharmaceutical products to market faster without sacrificing regulatory standards or human subject protection.

As seen in Applied Clinical Trials 

The four-day summit, which begins today, is a premier information-sharing forum covering issues of key importance to clinical research professionals. The event includes formal presentations from leading experts, case studies, breakout discussion groups and workshops.

Ms. Douglas’ presentation, “Understanding the Importance of Training in Minimizing Clinical Research Risk,” scheduled for 3:30 p.m. Oct. 12, is included in the summit’s Clinical Training Forum track. The presentation will explain how training has become a key factor in minimizing clinical research risk, particularly from an IRB perspective, including organizational benefits, metrics as support to implementing effective training programs, and three ways to ensure training best practices.

“Training initiatives play a significant role in the clinical research process, and best practices are imperative,” Ms. Douglas said. “The Barnett Clinical Summit presents an opportunity for clinical research professionals to learn more about current technologies, processes, and best practices that can be applied across their organizations’ training programs.”

After joining CGIRB in 2007, Sydney Douglas was responsible for providing training during CGIRB’s transformation from a paper-based company into a paperless organization. Additionally, she manages the corporate training program and facilitates training related to accreditation and certification. Ms. Douglas’ efforts earned CGIRB’s training program national recognition as a 2012 Training Top 125 company.

For more information, visit cgirb.com. For more information on the Barnett Clinical Training Forum, visit http://www.barnettclinicalsummit.com/clinicaltraining/

About Copernicus Group IRB
Experience and innovation in ethical review®
Copernicus Group IRB, established in July 1996, is a leading U.S. independent institutional review board (“IRB”) dedicated to ensuring the rights and welfare of research study participants. The IRB provides ethical review of research protocols, investigators, and subject information and consent forms to ensure compliance with federal regulations set forth in 21 CFR, 45 CFR and ICH/GCP Guidelines. CGIRB achieved full AAHRPP accreditation in 2004, reaccreditation in 2007 and 2011, and ISO 9001:2008 certification in 2010. For more information please visit http://www.cgirb.com

About Barnett International
Founded in 1979, Barnett International is widely recognized for its superior consulting services and its targeted education and training programs. Barnett helps clients get the most out of their research and development dollars by managing change effectively, improving organizational performance, and enhancing staff knowledge. The Barnett approach is a unique combination of strategy development and practical, hands-on implementation. The “Barnett Difference” is evident in our deep understanding of the clinical research process and in the rapid and tangible performance improvements we deliver.

We help pharmaceutical, biotechnology and medical device companies maximize the speed and quality of their product development efforts. With an international presence and many staff members working from the client site for increased benefits, Barnett is able to apply a global expertise to its projects. Our services include educational programs and products as well as consulting services. For more information, visit www.barnettinternational.com.

Ms. Ratledge spoke to students in Dr. Melissa A. Holland’s Principals of Clinical Research class. She gave an overview of the daily functions of institutional review boards and the elements of informed consent. Ms. Ratledge also discussed the types of reviews performed by CGIRB, touching on Full Board, Expedited and Exempt requirements.

In her most recent role as the Director of Quality Management, Ms. Higgins was responsible for overseeing CGIRB’s Human Research Protection Program and managing Quality Assurance & Compliance.

“The ethics experience Yvonne brings to CGIRB’s leadership team serves us well in upholding our mission to protect the rights and welfare of human subjects participating in clinical trials,” Dawn Pope, Chief Operating Officer, said. “With Yvonne’s guidance, our Quality Management department truly upholds our Quality Policy, which includes a commitment to continual process improvement. Our Quality Management team maintains our ISO quality management system and has an integral role in our Lean Six Sigma initiative – two of our most impactful programs. We congratulate Yvonne on her success and look forward to her future contributions.”

Ms. Higgins, a Certified IRB Professional (CIP), was as an AAHRPP site auditor for five years and served a two-year term as an AAHRPP Council Member. In addition to her contributions at AAHRPP, Ms. Higgins is a Public Responsibility in Medicine and Research (PRIM&R) member. She has earned several industry honors, including the PRIM&R Distinguished Service Award.

About Copernicus Group IRB
Experience and innovation in ethical review®
Copernicus Group IRB, established in July 1996, is a leading U.S. independent institutional review board (“IRB”) dedicated to ensuring the rights and welfare of research study participants. The IRB provides ethical review of research protocols, investigators, and subject information and consent forms to ensure compliance with federal regulations set forth in 21 CFR, 45 CFR and ICH/GCP Guidelines. CGIRB achieved full AAHRPP accreditation in 2004, reaccreditation in 2007 and 2011, and ISO 9001:2008 certification in 2010. For more information please visit http://www.cgirb.com.

About AAHRPP
The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) promotes high-quality research through an accreditation process that helps organizations worldwide strengthen their human research protection programs (HRPPs). For more information, visit http://www.aahrpp.org.

Ms. Pope came to CGIRB from Clinical Trials Support Services, Inc., in 1998. In her most recent role as CGIRB’s Director of Client Services, Ms. Pope was responsible for providing overall direction for the IRB Services, Study Start-Up and Project Management teams, which provide client support through all phases of the study lifecycle. Utilizing departmental metrics data and Lean principles, Ms. Pope helped her teams to increase productivity, annually exceeding corporate turnaround time goals. In addition to increasing review efficiency, Ms. Pope’s teams also developed department processes to measure and improve quality using a Six Sigma approach.

Prior to her role as Director of Client Services, Ms. Pope served as CGIRB’s Director of Quality Management, where she was responsible for leading CGIRB through AAHRPP recertification and into becoming the first ISO 9001:2008 certified central IRB.

“Dawn’s organizational and leadership skills have helped us to establish processes that further enable us to uphold our quality policy and mission,” CGIRB Executive Chairman Donald Deieso said. “Dawn’s knowledge of our clients and the challenges they face in the clinical trials industry, combined with her years of human subject protection experience, uniquely positions her to foster an environment of growth where protecting the welfare of human subjects is made a priority.”

Ms. Pope is a Certified IRB Professional (CIP) and served as CGIRB’s institutional officer from 2009 to 2012.

About Copernicus Group IRB
Experience and innovation in ethical review®
Copernicus Group IRB, established in July 1996, is a leading U.S. independent institutional review board (“IRB”) dedicated to ensuring the rights and welfare of research study participants. The IRB provides ethical review of research protocols, investigators, and subject information and consent forms to ensure compliance with federal regulations set forth in 21 CFR, 45 CFR and ICH/GCP Guidelines. CGIRB achieved full AAHRPP accreditation in 2004, reaccreditation in 2007 and 2011, and ISO 9001:2008 certification in 2010. For more information please visit http://www.cgirb.com.

About ISO
ISO (International Organization for Standardization) is the world’s largest developer of voluntary International Standards. International Standards give state of the art specifications for products, services and good practice, helping to make industry more efficient and effective. Developed through global consensus, they help to break down barriers to international trade. For more information, please visit http://www.iso.org.

About AAHRPP
The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) promotes high-quality research through an accreditation process that helps organizations worldwide strengthen their human research protection programs (HRPPs). For more information, visit http://www.aahrpp.org.

Each year, Carolina Parenting Inc., honors North Carolina companies that help working parents by offering family-friendly programs, policies and opportunities. Winning companies were selected based on nominations and supporting information with the help of the UNC Kenan-Flager Business School in Chapel Hill.

CGIRB, an employee-focused company, was recognized for its outstanding investment in its employees through providing flexible work options that include compressed workweeks, part-time work and telecommuting. These programs and benefits help CGIRB’s employees to enjoy an excellent work-life balance.

Additionally, CGIRB was acknowledged for its weekly food truck program, in which scheduled food trucks park on-site. This added benefit encourages staff to invite their family for lunch and allows them to spend time together over the lunch hour.

“Being named to the 2012 N.C. Family-Friendly 50 list is a unique honor for Copernicus,” Chief Operating Officer Dawn Pope said. “We’ve long been dedicated to creating an environment that empowers employees to achieve a fulfilling work-life balance. The result is a low employee turnover rate, which helps us to better serve our valued clients by ensuring that they work with consistent points of contact and highly experienced employees.”

“This recognition is a true testament to the level of commitment by the company and management team,” Assistant Director of Human Resources Administration Tamara Bowles said. “We know our greatest assets walk in and out of the office every day. Many of our staff members are parents, and it’s a great way to remind them of the programs offered and available to help support them in all aspects of their lives.”

Joining CGIRB among the 2012 N.C. Family-Friendly 50 Companies are such leading firms as Blue Cross Blue Shield of North Carolina, Qualcomm and IBM Corporation. For more information or to see the full list of winners, visit NCFamilyFriendly.com

About Copernicus Group IRB
Experience and innovation in ethical review^®
Copernicus Group IRB, established in July 1996, is a leading U.S. independent institutional review board (“IRB”) dedicated to ensuring the rights and welfare of research study participants. The IRB provides ethical review of research protocols, investigators, and subject information and consent forms to ensure compliance with federal regulations set forth in 21 CFR, 45 CFR and ICH/GCP Guidelines. CGIRB achieved full AAHRPP accreditation in 2004, reaccreditation in 2007 and 2011, and ISO 9001:2008 certification in 2010. For more information please visit http://www.cgirb.com

About Carolina Parenting’s N.C. Family-Friendly 50
Many N.C. companies offer flexibility, generous benefits, innovative programs and other perks to make it easier for parents to juggle the demands of work and family. For 14 years, Carolina Parenting, which owns Carolina Parent, Charlotte Parent and Piedmont Parent, has highlighted companies that support and encourage working parents in North Carolina. These companies are exemplary in creating a family-friendly work culture and should be applauded for these efforts.

Barnett International & Cambridge Healthtech Institute’s Clinical Summit features four co-located conferences covering issues that are of key importance to clinical research professionals. The four-day summit will include formal presentations from experts, as well as case studies, interactive breakout discussion groups, workshops and networking opportunities, and will provide a forum for all involved in clinical trials to share ideas, proven practices, and recent research findings.

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A Certified Records Manager since 1996, Mitchell will make a presentation entitled “Do You Know What You Have? Understanding How Data Creation Can Make You a Smart Decision-Maker” on Tuesday, Oct. 30. The presentation will reveal how to take advantage of data to make sound decisions, distribute business-critical information through web-based reports and dashboards and prioritize work on critical and late-stage projects.

The 2012 DOCUMENT Strategy Forum, which runs Oct. 29-31, is focused on educating and enlightening producers of transactional/customer communication. The event features talks and presentations from industry leaders, like Mitchell, and an exhibit hall showcasing companies that cover the full spectrum of the document life cycle.

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To sit for the Certified Quality Improvement Associate examination, candidates must have at least two years of work experience related to the knowledge of quality tools and their use in quality improvement projects.

ASQ is a global community of people dedicated to sharing tools and ideas for effective quality improvement.  It provides certification as a way of formally recognizing professionals who have shown an understanding of, and commitment to, quality techniques and practices throughout their careers.  As a result, the quality champions that ASQ admits are now transforming the world’s corporations, organizations, and communities by finding innovative solutions to meet future challenges.

Effective collaboration with your institutional review board can help prevent delays in start-up activities that  can cost sponsors and CROs valuable time and negatively impact site enrollment activities. In this quarter’s  newsletter, Copernicus Group IRB’s Director of Client Services, Dawn Pope, explores ways Sponsors, CROs and  sites can take advantage of the latest collaborative tools to keep the channels of communication open with the IRB, streamlining the submission process and shortening review timelines.

Before Protocol Submission

Use these methods to ensure effective communication, efficient IRB reviews

Technology

As an internally paperless IRB, we see how dramatically technology can impact efficiency. At one time, Sponsors and CROs had to rely on email and telephone communications to check the status of their IRB submissions, and investigator sites had to rely on couriers to provide their IRB approval documents. Using CGIRB Connexus®, our electronic document management system, Sponsors, CROs and sites have real-time access to their submission’s review status and can submit and retrieve documents with the click of the mouse. They get instant automated receipts for each submission and notification when approvals are granted. Fully utilizing Connexus® permits Sponsors and CROs to manage every aspect of their sites’ submissions in one organized workspace, allowing them to track submissions, sort and retrieve documents and grant study workspace access to colleagues.

Taking advantage of technology like CGIRB Connexus® can help to avoid delays and improve IRB review timelines

Prior to submitting a study, become familiar with the IRB’s electronic capabilities.

• CGIRB provides CGIRB Connexus® training. If you are unfamiliar with the system, be sure to attend a training session to learn about all of the system’s capabilities.
• Do you want to invite your colleagues to have access to your study workspace? If so, invite them to participate in training as well. CGIRB can arrange group training sessions via webex to accommodate your team.
• Will sites be receiving hard copies or will the study be completely paperless? If no hard copies will be provided, a CGIRB administrator can help you to notify sites to register for access to their documents and encourage them to attend training.

Communication

Bringing the right people on board at the beginning of the submission process will help to ensure that information is consistently delivered to all stakeholders. Developing clear communication channels is an important step in streamlining processes. Much of the information in the following section is covered during study initiation calls.

As you begin the submission process, remember to consider the following:

Establish Study Contacts

• Identify the primary contact for the study and provide their contact information to the IRB. Also identify and provide contact information for:
• Anyone who should be copied on all documents
• Anyone who will be contacted for questions regarding the protocol
• Anyone who should be contacted for questions regarding Principal Investigator (PI) applications
• Identify a secondary contact as backup in case the primary contact is unavailable and provide their contact information
• Are you knowledgeable about the IRB and their procedures? If not, call and introduce yourself. Ask questions regarding the IRB submission requirements and timelines. Establish a contact within the IRB to work with throughout the submission process.
• Are there any unique qualities about your study that you would like to discuss with the IRB prior to your formal submission? CGIRB staff may be able to provide guidance on how to prepare your submission to address any concerns or issues prior to the IRB meeting.
• CGIRB offers study-initiation calls to go over study-specific expectations and answer questions prior to the scheduled IRB meeting to work through the details of your submission. Invite colleagues to join the meeting to familiarize themselves with the CGIRB team and learn about the review process.

IRB Submission Requirements

Understanding what the IRB requires to perform the review process and providing complete information will help cut down on follow-up work.

As you gather the documents for your submission, remember to consider the following:

• Informed Consents
• How many Informed Consents will there be? Are there any sub-study consent forms that will only be used for certain sites? CGIRB has online templates to use for Informed Consent development.
• If vulnerable populations are involved, are the appropriate assent forms ready for IRB review? CGIRB has a list of FAQs regarding assent to assist you.
• Will the Sponsor’s legal department have to review changes made by the IRB? If so, customized templates can be negotiated with the IRB prior to study submission.
• Will translated ICFs or other study information be allowed? If so, will CGIRB provide translation services or will the sponsor provide certified translations of CGIRB-approved ICFs?
• Are there any specific HIPAA language considerations? If yes, discuss the considerations with CGIRB in advance to avoid delays during the review process.

• Subject recruitment/retention materials or advertisements
• Will there be any subject recruitment or advertisements submitted? If so, remember to submit them with the protocol.
• If sites have their own advertisements, will these require sponsor/CRO approval prior to submission??
• If a third party will be preparing recruitment items, will they need access to Connexus® to help with the submission of these items for IRB review?

• Submission and Forms
• CGIRB will answer any questions you may have regarding Principal Investigator application requirements during your study initiation call. Be certain to use the most current version of IRB forms by downloading them directly from www.cgirb.com.
• Consider how investigator documents will be submitted to CGIRB. Will they be coming from the Sponsor, the CRO, or individual sites? Explain the process to your CGIRB team during the study initiation call.
• Ensure that each investigator is trained in GCP (or other IRB requirements regarding education and training). CGIRB can provide resources (CITI Training) for research-naïve sites.
• Are there any conflicts of interest for Principal Investigators involved in the study? If so, CGIRB has a form for the PI to complete and can provide guidance.
• Communicate with sites or others on your project team to assure that they understand that complete submissions ensure timely turn around and incomplete documents that are submitted will delay the review process.
• Will there be any pediatric subjects or other vulnerable subjects enrolled? If so, are there special protections in place?
• Ensure that sites are aware of applicable state laws regarding research.

After Protocol Approval

Keep the lines of communication with the IRB open after the study has been approved

Study Maintenance

Continuing to communicate with CGIRB after the study has been approved is important. Prompt safety reporting and notification of changes to research are vital to subject protection.

During the study maintenance phase, there are different IRB requirements to consider:

• Unanticipated problems
• How will IND Safety reports, if any, be submitted to the IRB during the study? CGIRB encourages submissions directly from the sponsor rather than individually from each investigator.
• How will the reporting of Serious Adverse Events and Protocol Deviations be handled during this study? Will there be a standard reporting form?
• Are you familiar with the IRB’s requirements for which UPs require reporting? If not, your CGIRB contact will provide guidance.

• Other Maintenance Submissions
• Remember to notify CGIRB when staffing changes occur in order to ensure that notifications will be delivered to the correct study contacts.
• Will there be any Clinical Investigator Brochure updates? If so, provide them to CGIRB in a timely manner.
• Is there a process in place that allows for prompt communication of any changes in the research to CGIRB, such as modifications or amendments? Are you familiar with the IRB’s review process for reviewing materials submitted after initial review? If not, your CGIRB contact will guide you through the submission.
• Are you familiar with the IRB’s Continuing Review process? CGIRB will contact you two months prior to the study expiration date and provide Continuing Review forms.
• Each site is required to submit a study close out form. When CGIRB receives notice of study closure from the sponsor or CRO, study close out forms are provided to sites.

For additional information, contact CGIRB.

Veit, a frequent industry speaker, was joined by co-panelists from Duke Medicine, Harvard University and the Duke University Health System IRB to present information on the obstacles faced in conducting multiregional clinical trials. Veit’s presentation specifically addressed the challenges IRBs and other stakeholders in clinical research face regarding safety reporting and the exceedingly high volume of reports received. Veit referenced recent guidance from the U.S. Food & Drug Administration (FDA) aimed at reducing the reporting burden and offered solutions to decreasing over reporting.

The symposium, led by CGIRB in collaboration with the Drug Information Association (DIA) and the Duke Clinical Research Institute (DCRI), focused on creating synergy in the conduct of global clinical trials.

“It’s clear that there are emerging issues in global clinical research that need to be addressed,” Veit said. “Hearing the perspectives of my co-panelists and the thought-provoking questions from attendees illustrated the fact that there is a lot of work that we, as an industry, have to do to become real leaders in improving efficiencies and data quality and ensuring the safety of human clinical trial subjects at home and internationally.”

About Copernicus Group IRB
Experience and innovation in ethical review®
Copernicus Group IRB, established in July 1996, is a leading U.S. independent institutional review board (“IRB”) dedicated to ensuring the rights and welfare of research study participants. The IRB provides ethical review of research protocols, investigators, and subject information and consent forms to ensure compliance with federal regulations set forth in 21 CFR, 45 CFR and ICH/GCP Guidelines. CGIRB achieved full AAHRPP accreditation in 2004, reaccreditation in 2007 and 2011, and ISO 9001:2008 certification in 2010. For more information please visit http://www.cgirb.com

About the Drug Information Association
The Drug Information Association (DIA) is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related medical products. Through international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and wellbeing worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India and Beijing, China. www.diahome.org.

About Duke Clinical Research Institute
The Duke Clinical Research Institute (DCRI), the world’s largest academic clinical research organization, is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making 40 years after its founding. www.dcri.org

In addition to CGIRB staff members, speakers included representatives from top academic institutions Yale, Harvard and Duke, industry-leading corporations Merck, Sanofi and Celgene, and the U.S. Food and Drug Administration (FDA).

“The symposium attracted a unique group of panelists,” said CGIRB Vice President and Chief Business Development Officer Bill Van Nostrand. “For me, as a member of the program committee, it was a remarkable experience to work with the panelists and refine the theme for each session. The blending of unique experiences and perspectives enhanced the overarching theme of collaboration.”

Yvonne Higgins, CGIRB’s Director of Quality Management, served as the symposium’s committee co-chairperson. She was instrumental in building the event’s roster of world-renowned speakers.

“It was inspiring to work with each of the panelists,” said Higgins, who also moderated a panel discussion on investigator certification, accreditation of human research protection programs HRPPs and qualification standards Phase 1 clinics. “Having a group with this much experience from so many respected organizations created a platform for innovation and new ideas to be shared.

The symposium’s question and answer sections were particularly stimulating. Attendees posed questions about the hurdles they face in conducting multi-regional clinical trials; and the expert panelists offered advice and solutions which created an exciting atmosphere of partnership.”

About Copernicus Group IRB
Experience and innovation in ethical review®
Copernicus Group IRB, established in July 1996, is a leading U.S. independent institutional review board (“IRB”) dedicated to ensuring the rights and welfare of research study participants. The IRB provides ethical review of research protocols, investigators, and subject information and consent forms to ensure compliance with federal regulations set forth in 21 CFR, 45 CFR and ICH/GCP Guidelines. CGIRB achieved full AAHRPP accreditation in 2004, reaccreditation in 2007 and 2011, and ISO 9001:2008 certification in 2010. For more information please visit http://www.cgirb.com

About the Drug Information Association
The Drug information Association (DIA) is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related medical products. Through international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and wellbeing worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India and Beijing, China. www.diahome.org.

About Duke Clinical Research Institute
The Duke Clinical Research Institute (DCRI), the world’s largest academic clinical research organization, is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making 40 years after its founding. www.dcri.org