The Challenge
A leading global pharmaceutical company was ready to scale hybrid clinical trials for its Food for Special Medical Purposes (FSMP) product. But regional complexity brought things to a grinding halt. Regulatory frameworks for hybrid and decentralized clinical trials (DCTs) vary drastically around the world, and there’s no single harmonized playbook.
Navigating different rules around eConsent, digital health tools, home healthcare professional (HHCP) visits, data privacy, and remote monitoring created serious roadblocks. The question wasn’t just how to launch, but where, when, y under what rules.
The RegASK Approach
As an AI-driven agentic solution for regulatory intelligence and workflow orchestration, RegASK stepped in to bring clarity to complexity.
We delivered a set of DCT Regulatory Guidebooks for 27 strategic markets. Each guidebook included:
- Clear, validated insights on local DCT regulations
- Side-by-side comparisons to assess regulatory readiness
- Practical Q&A navigation to support clinical ops and regulatory teams
- Continuous updates to keep teams aligned with evolving rules
Aspectos destacados clave
- 27 jurisdictions covered
- 90% time saved to compile the country regulations
- Ease to access data
The Result
RegASK didn’t just provide information – we delivered confidence:
- Enabled faster, evidence-based decision-making on trial design and launch strategy
- Eliminated time-consuming manual research across multiple geographies
- Supported compliant, scalable execution of hybrid trials across global markets
With RegASK, the client transformed regulatory uncertainty into a competitive advantage.
Frequently Asked Questions
Q1: Why are hybrid and decentralized trials so complex from a regulatory standpoint?
Hybrid and DCTs often involve components—like virtual engagement, remote monitoring, eConsent, and digital health tools—that are governed differently in each market. There’s no global standard, which makes it difficult to scale without deep, localized intelligence.
Q2: How does RegASK help simplify DCT compliance across regions?
RegASK combines AI-driven regulatory intelligence with expert-curated guidebooks tailored to 27 key markets. Our guidebooks help teams instantly understand what’s allowed, what’s not, and where the gaps are—reducing trial planning cycles from weeks to days.
Q3: What’s included in the DCT Regulatory Guidebooks?
Each guidebook covers core DCT components: eConsent validity, HHCP home visits, data privacy requirements, digital platform use, and more. The information is structured in a user-friendly Q&A format, backed by primary sources and updated regularly.
Q4: How does RegASK stay ahead of fast-changing DCT regulations?
Through RegAlerts, our AI system monitors and curates regulatory updates relevant to DCTs and FSMPs. You’ll get timely, actionable updates—so your teams can plan proactively instead of reacting to changes late.
Q5: What is the role of AI in improving regulatory decision-making for clinical trials?
AI accelerates insight generation by analyzing volumes of regulatory data, surfacing patterns, and summarizing requirements. RegASK’s generative engine contextualizes this data to your market, product type, and trial model—so you get answers, not just documents.
Q6: Can RegASK integrate with our current trial planning systems?
Yes. RegASK is designed to be interoperable. With features like API access and customizable reporting, you can embed regulatory intelligence directly into your workflows, tools, and dashboards.
Q7: Is RegASK secure enough for clinical research applications?
Absolutely. RegASK is ISO 27001 and SOC 2 Type II certified. We’re committed to the highest standards in data protection, system reliability, and confidentiality.
