It’s Time to Harmonize Clinical Trial Site Standards

ABSTRACT | Climbing costs and lengthy time frames of clinical trials are significant
bottlenecks in medical product development. Despite the fact that scientific discoveries
yield many new possible targets for developing into therapies, the capacity
and resources with which to develop these targets are limited, thereby leaving potentially
valuable discoveries undeveloped and unrealized. Under the aegis of the
Clinical Trial Site Standards Harmonization Action Collaborative (“the Collaborative”)
of the Forum on Drug Discovery, Development, and Translation of the National
Academies of Sciences, Engineering, and Medicine, clinical research stakeholders
set out to discuss opportunities to improve clinical trial site functioning, with the
goal of increasing productivity in medical product development. Our conclusion:
harmonization of standards for clinical trial sites has significant promise in improving
clinical trials. Standards would also be essential to the formation of a site accreditation
system in the United States, should a consensus emerge on the need
for such a system. This paper synthesizes the results of the work conducted to
inform discussions of the Collaborative. This paper may serve as a launching point
for harmonizing requirements applied to clinical trial sites and the development of
standards. A clinical trial infrastructure that reduces redundancies and increases efficiencies
would, in turn, accelerate the pace and productivity of new product development,
to the benefit of patients and society.

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Medidata and RapidTrials

Medidata and RapidTrials

Industry Spotlight: RapidTrials CEO Tracy Harmon Blumenfeld

by Geeks Talk Clinical

We like to highlight people that are doing interesting work in our industry, and this week we want to put the spotlight on Tracy Harmon Blumenfeld. Tracy and her company RapidTrials recently sold us a patent that covers systems and methods for evaluating the performance and progress of clinical research trials. 

Access to real-time, site-level benchmarking data is vital for companies that need to be able to shift course quickly in all aspects of clinical development programs. With the data in hand, company sponsors working in collaboration with their sites can make a significant impact on the development process.

“What’s unique about RapidTrials approach is we made real-time, protocol-specific metrics and benchmarking information available to site personnel as well as sponsors,” Tracy said in an interview.

“Sites want access to comparative information that can help them to be successful. Sharing benchmark information forces sites to ask the question, ‘What are the best practices that drive results leading to rapid identification of corrective actions that will work?’” she added.

Tracy cofounded RapidTrials in 1996 to streamline clinical trial implementation. She works with research sites, CROs and pharma companies to achieve faster study enrollment and more efficient trials by offering study feasibility, site selection, patient recruitment, and site resourcing and site management services. Tracy co-founded RapidTrials with a physician after both met and worked at contract research organization Parexel International. At Parexel  she gained valuable experience understanding the key metrics that drive efficiency and performance of clinical trials and developing benchmarking products to help sponsors improve their internal clinical trial operations.

As a vehicle to deliver real-time metrics, benchmarking and best practices to sponsor companies and research sites, RapidTrials created the Performance Gateway collaboration portal. The Performance Gateway streamlines study start-up, patient recruitment and data quality. Performance Gateway allows sponsors and sites to view recruitment data, site effort and resourcing information, financial indicators and performance projections.

“Whether during study planning, start-up or implementation, RapidTrials consistently has a measurable impact on site efficiency including: reducing time to study start-up, increasing enrollment rate, and reducing screen failure and drop-out rates. Getting metrics and data to the people that can have the greatest impact has been key to our success,” Tracy said.

Our own Glen de Vries has worked with Tracy for years. “Tracy and her leadership team started their careers in managed care and healthcare operations, which has provided them with significant competitive advantage in helping sites integrate clinical trials at their practices and institutions,” Glen said.

“Tracy’s vision for clinical trial efficiency and the innovative methods she has developed to improve operational performance have influenced the industry. I’m excited to see what valuable insights she will generate next to help shape the clinical trials of the future,” Glen added.

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RapidTrials to assist ACRES with SASI Steering Committee Leadership

Cambridge, Massachusetts, USA
March 12, 2013
For immediate release. 
Collaborative Initiative to Develop Standards for Clinical Research Sites Underway
--Meyerson and Blumenfeld leading effort
Alliance for Clinical Research Excellence and Safety (ACRES) President, Greg Koski, former director of the Office for Human Research Protections (OHRP) at the U.S. Department of Health and Human Services, announced a major step forward in efforts to re-shape the world of clinical research through a collaborative systems approach that leverages the expertise and resources of stakeholders world-wide.
ACRES Site Accreditation Standards Initiative (SASI), inaugurated in December of 2012, has teamed up with industry leaders Linda Meyerson and Tracy Blumenfeld who will serve as Co-Chairs of the SASI Steering Committee.  SASI brings together prominent members from the multi-sector biomedical research community to promote formal standards for accreditation of clinical research sites worldwide.  
With more that 250,000 research sites around the globe, numbers that are rapidly growing outside of the traditional bases in North America and Europe, the development of such standards represents a critical step toward creating a global system to enhance safety, quality, ethics and efficiency in clinical trials and health research.
Meyerson recently retired as the chief operating officer at Icon CR, a Philadelphia-based pharmaceutical services company where she was responsible for handling clinical operations, conducting clinical trial programs, and analyzing data that support clinical development and clinical study.  She was formerly the vice president for global clinical operations at GlaxoSmithKline.  
Tracy Harmon Blumenfeld is the co-founder, president and CEO of RapidTrials, a leader in improving the efficiency of clinical trials.  For the past decade, RapidTrials has been at the forefront of aiding sponsors in selecting, assessing, and managing sites, with an end result of significantly faster enrollment and more efficient, high-quality trial execution. 
“The research site is a critical element of a clinical trial. Despite this vital role in the research process, no uniform standards exist to define the requirements of sites or distinguish levels of quality among sites.  SASI is a collaboration of global leaders in clinical research to define site standards so that we can enhance safety, quality and efficiency of drug development”, says Blumenfeld.  
Over the next two years, SASI working groups, representing all key stakeholder groups, will develop and pilot test standards in at least four areas: facilities, professional personnel, information technology and quality management.  Standards will provide the foundation for globally recognized, third-party
accreditation of research sites that will ensure industry-wide inter-operability and efficiency, while driving standardization, safety and quality in clinical trial conduct worldwide through a global network system.   
Meyerson notes, “It's all about quality--while cost and time matter in clinical trials, ultimately success depends on quality, and site excellence is a hallmark of quality. With quality sites everyone wins, sponsors, clinicians, regulators and most importantly, patients.”
Through its alliance-based approach, ACRES seeks to integrate its efforts with complementary activities being conducted by like-minded organizations, including The Multi-Regional Clinical Trials Center at Harvard (MRCT), the Metrics Champion Consortium (MCC), the Association of Clinical Research Professionals (ACRP),  the Health Improvement Institute (HII), PharmaTrain, the Consortium of Academic Programs in Clinical Research (CoAPCR), the Society for Clinical Research Sites (SCRS) and Model Agreements & Guidelines International (MAGI) among others. 
 “To be successful, this initiative must be collaborative and informed by the wisdom and needs of the sites themselves”, says Koski.  “In addition to the sites, there are many stakeholders in the clinical research process, not the least of which is the public, and all will benefit. Standards and accreditation are proven methods for building public trust by ensuring quality and enhancing safety, while driving standardization and efficiency.  Accreditation also affords an opportunity for sites to demonstrate their commitment to quality and safety.  This initiative is greatly needed and long overdue.” 
ACRES is a private, non-profit, multi-sector organization operating in the public-interest, aligning ethical principles and good business practices to address critical challenges facing the drug and device development in a socially responsible manner.  
ACRES is working together with stakeholders and like-minded organizations world-wide to develop siteaccreditation standards, launch safety and quality initiatives, and to build a global technology network to support the clinical research system and its oversight. Through standardization of policies and procedures, regulatory simplification, professionalism and information technology, the ACRES system will enhance safety, quality and efficiency while reducing the cost and time required to responsibly deliver new medical products and better health to the people of the world.
For Further Information
More information about ACRES and its initiatives is available at
Global Headquarters: One Broadway, 14th Floor, Kendall Square, Cambridge, MA, 02142. 
Contact: Dr. Greg Koski at

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