Regulatory Guidebooks Paved the Way for Decentralized Clinical Trials 

Regulatory Guidebooks Paved The Way For Decentralized Clinical Trials

The adoption of hybrid and decentralized clinical trials (DCTs) has been accelerating across the world. According to Everest Group, 90% of the industry will incorporate some DCT components for their clinical trials by 2024. However, challenges have also increased for sponsors and Contract Research Organizations (CROs) to carry out DCTs successfully. One of the key challenges is accessing and understanding the regulations. 

The regulatory landscape surrounding the implementation of DCTs is complex and fragmented. DCT regulations are evolving with constant changes and are varying country by country. But a consolidated global regulatory guidance on the DCT landscape is yet to be developed, which brings many uncertainties and potential delays in trial implementation.  

To help sponsors and CROs overcome the challenges, RegASK has developed a series of DCT regulatory Guidebooks covering 24 countries, which provide vital and validated information on the current DCT regulatory framework, with a deep dive into DCT elements and their nuances. The information in the guidebooks is presented in an easy-to-comprehend digital library that allows readers to understand the general clinical trial regulatory framework and DCT components in a faster and painless manner.  

Read the case study and learn how RegASK’s Guidebooks assist CROs in all regulatory aspects of hybrid or decentralized clinical trials for efficient and successful trial implementation.  

Objective

A global CRO specializing in virtual clinical trials has been providing tech-enabled DCT solutions to clinical trial sponsors around the world. When they were planning to register a DCT in a new country or use tech-enabled solutions within a clinical trial, regulatory questions arise and often become a blocker that delays the trial.  

To guide their trial implementation, the team was manually gathering regulatory information from DCT regulators in different countries, which is time-consuming, disorganized, and insufficient to answer all their questions related to trial registration and execution. 

The CRO was looking for a one-stop regulatory service that can provide complete and thorough insights into the global DCT regulatory landscape to better guide their clients for clinical studies execution and help them improve clinical trial efficiency. 

Solution

  • RegASK developed detailed Guidebooks highlighting all the aspects of the regulatory requirements to implement hybrid or fully decentralized clinical trials in over 20 markets covering Asia, LATAM, EU, and North America. The digital Guidebooks cover end-to-end information needed to build a DCT strategy, from importing the investigational samples, location and qualification requirements of investigators, eConsent, eSingature, ePRO, HHCP visits to verification and validation of data storage protocols, and data transfer regulations.
  • RegASK produced a country requirement overview for the registration of digital clinical studies, and designed a roadmap for the submission process. 
  • The Guidebooks are constantly updated through RegASK’s intelligence and ongoing monitoring solution – the RegAlert platform. 

Results

The CRO gained clarity on the regulations related to DCT registration and implementation, allowing them to plan and implement DCTs in 20 countries and beyond, saving them hundreds of hours on regulatory research and significantly boosting their trial efficiency.  

 

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