As the COVID-19 pandemic continues to disrupt clinical research, there is an increased need from the pharmaceutical and CRO industry to implement decentralized or hybrid clinical trials (DCTs) for improving clinical trial efficiency.
Read our case study to know how RegASK assists CROs in fulfilling the regulatory requirements for implementing DCTs across different countries.
Challenge
A virtual research organization wanted to gain regulatory insights of DCTs across 16 countries/regions to better guide their clinical trial execution. However navigating the regulatory landscape of DCTs and staying compliant is not easy. The regulations are varying significantly from country to country and are not always fully matured. Life sciences and CRO organizations are subject to regulatory changes, which brings uncertainties and delays in clinical trial implementation.
Solution
RegASK provided comprehensive regulatory affairs solutions on DCTs including:
- Full Guidebooks answering questions related to clinical trial regulations, from study design to a step-by-step guide on how to register a clinical trial
- A Knowledge Card answering specific regulatory questions
- A roadmap of the submission process
- Access to the RegAlert regulatory monitoring platform which uses AI to provide updates to the Guidebooks and Knowledge Card
Results
The client gained specific regulatory expertise that did not exist in-house and reduced the cost of monitoring (no need for additional hires). More importantly, they gained peace of mind regarding the regulatory changes on DCTs so that they could focus on scaling their business.
