The Challenge
A leading global pharmaceutical company was preparing to scale hybrid clinical trials for its Food for Special Medical Purposes (FSMP) product. However, the diverse and evolving regional regulations posed a major hurdle to scaling the trials effectively.
Regulatory frameworks for hybrid and decentralized clinical trials (DCTs) vary significantly across the globe, and no harmonized playbook exists.
The requirements for eConsent, digital health tools, home healthcare professional (HHCP) visits, remote monitoring, and data privacy differ substantially by jurisdiction. The challenge was not just how to execute the trials, but understanding which regulations applied in each country, highlighting the need for tailored regulatory playbooks to guide local implementation.
The RegASK Approach
RegASK, by combining its AI-driven regulatory intelligence solution with its deep domain expertise, brought structure to the complexity.
We delivered a set of DCT Regulatory Guidebooks for 27 strategic markets. Each guidebook included:
- Clear, validated actionable insights on local DCT regulations
- Side-by-side country comparisons to assess regulatory requirements and readiness
- Practical Q&A navigation to support clinical ops and regulatory teams
- Continuous updates to keep teams aligned with evolving regulatory landscapes
Key Highlights
27
jurisdictions covered
90%
time saved to compile the country regulations
Ease
to access data
The Result
RegASK enabled faster, more confident trial planning and execution by:
- Enabled faster, evidence-based decision-making on trial design and launch strategy Empowered clinical and regulatory teams with up-to-date, localized intelligence
- Eliminated time-consuming manual research across multiple countries
- Supported compliant, scalable hybrid clinical trial deployment across global markets
From regulatory uncertainty to competitive edge, RegASK delivered clarity, confidence, and speed.
Frequently Asked Questions
Q1: How does RegASK help simplify DCT compliance across countries?
RegASK simplifies Clinical trials implementation compliance by providing clear, validated insights into country-specific regulatory requirements. Our expert-authored guidebooks and global intelligence platform help stakeholders understand local rules for decentralized components like eConsent, telemedicine, and remote monitoring; enabling consistent, compliant trial strategies across diverse regulatory environments.
Q2: What content do the Regulatory Guidebooks cover?
RegASK’s Regulatory Guidebooks offer country-specific insights into the clinical trial landscape, covering the ethics committee process, timelines, and decentralized elements such as eConsent, e-signature, and data handling. They support effective planning and regulatory navigation for trials in target markets.
Q3: How does RegASK stay ahead of fast-changing regulations?
RegASK stays ahead of fast-changing regulations through a combination of:
• advanced AI-driven monitoring tools
• a global network of regulatory experts
• continuous analysis of official updates and industry trends
This enables us to deliver near real-time, validated insights that help clients adapt quickly and maintain compliance across markets.
