SOUTHBOROUGH, MA – October 13, 2022 – Veristat announced that it has joined an alliance of over 120 life sciences and healthcare organizations whose mission is to accelerate the broad adoption of patient-focused, decentralized clinical trials and research. The Decentralized Trials & Research Alliance (DTRA) unites industry stakeholders which include healthcare companies, regulators, patient groups, clinical research and development organizations. The Alliance is dedicated to making clinical trial participation widely accessible by advancing policies, research practices and new technologies in decentralized clinical research.
“I am pleased to welcome Veristat to DTRA,” said Amir Kalali, MD, founder of several collaborative life science communities and co-Chair of DTRA. “By advancing decentralized research, we can make the clinical trial process more patient-focused, increase trial efficiency and encourage use of technologies.”
When compared to more traditional methods of conducting clinical trials, decentralized clinical trials (DCTs) can have a positive impact on study sites, the clinical trial process, and the patient experience. While there are many aspects of a trial that can be decentralized, Veristat’s approach to DCTs eases the burden on patients and sites through bespoke decentralized solutions including remote monitoring, patient reported outcomes, centralized sites, e-consent, and at-home nursing. In addition, Veristat has introduced its own virtual site, inclusive of patient accrual, call-center intake, centralized rating and protocol visit completion.
“Disruption across the traditional clinical trial model has served as an accelerator to taking bold, new and inclusive approaches to conducting decentralized clinical trials for advanced therapies,” stated Shaheen Limbada, Executive Vice President of Innovation and Strategy, Veristat. “Leveraging virtual trial tools and strategies designed for complex studies supports Veristat’s goal of reducing the burden on patients while delivering increased trial efficiencies to save our sponsors time and costs.”
The current and ongoing benefits to having decentralized and virtual trial components despite the world seemingly opening up from COVID lockdowns is that the use of these components in clinical trials can reduce the strain of participation and travel on patients — one of the primary barriers to patient recruitment and retention. Additionally, decentralized approaches facilitate participation by a more diverse patient population. Inclusion of representative patient populations in clinical trials by race, age and geographic location has long been an operational challenge. To support meaningful diversity, the U.S. Food and Drug Administration (FDA) recently released updated draft guidance on the representation of racial and ethnic minorities in clinical trials. The guidance recommends sponsors submit to the FDA a Race and Ethnicity Diversity Plan early in clinical development.
“Now is the time to share ideas and insights that will chart the future course of clinical trials, accelerating drug development and impacting lives,” said Craig Lipset, DTRA co-Chair. “By taking part in DTRA, Veristat is joining the many entities that are contributing to this mission. We have a responsibility to advance the health of people with unmet medical needs, and by convening stakeholders we can remove remaining barriers to adoption and impact patients today.”
Veristat, a scientific-minded global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 27 years of experience in clinical trial planning and execution, Veristat is equipped to support any development program.
Veristat’s focus on novel drug development has led to success when handling the unknowns that arise across complicated therapeutic areas, such as rare/ultra-rare disease, advanced therapies, oncology, and infectious disease trials. Every day, we apply this knowledge base to solve any clinical program’s challenges, from the simplest to the most complex. Veristat has assembled an extraordinary team of experts worldwide who have mastered therapeutic development intricacies, enabling sponsors to succeed in extending and saving lives.
Lauren L. Brennan, V.P. of Marketing
The Decentralized Trials & Research Alliance (DTRA) was convened to enable collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research. It works to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods.
DTRA Media Contact:
Glenn Silver, Lazar – Finn Partners