Blog — Insights & Updates

ClinicalMay 20, 2026 4 min

What to Look for When Selecting a CRO for IVD Performance Studies

Not every CRO is equipped for IVD performance studies. Learn the nine capabilities that matter most for compliant, defensible evidence generation.

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ClinicalMay 20, 2026 5 min

Three Sponsorship Models for Combined IVD-Drug Studies: How to Choose the Right One for Your Program

Explore the three main sponsorship models for combined IVD-drug studies and learn how governance structures impact compliance, timelines, and data ownership.

ClinicalMay 20, 2026 3 min

Delegation vs. Transfer of Sponsor Responsibilities: The Line Every IVD Performance Study Sponsor Needs to Draw

Understand the difference between delegating operational tasks and transferring Sponsor responsibilities in IVD performance studies under IVDR and FDA frameworks.

ClinicalMay 20, 2026 4 min

Who Is the Sponsor of Your IVD Performance Study and Why It Matters More Than You Think

Learn who carries Sponsor responsibility in IVD performance studies and why this role shapes compliance, data ownership, and regulatory success.

Software Solutions & ServicesMay 17, 2026 5 min

Why Most AI Pilots Fail in Regulated Environments and How to Fix It

Discover why AI pilots in pharma often fail before production and how governance, workflows, and data foundations determine success.

Software Solutions & ServicesMay 13, 2026 7 min

How MedTech's AI Playbook Can Accelerate Compliant AI Adoption in Pharma

Discover how MedTech's validated AI approach can help pharma accelerate compliant AI adoption across R&D, clinical trials, and GMP operations.

Software Solutions & ServicesMay 13, 2026 3 min

AI in Life Sciences: From Hype to Compliant Reality

Discover why governance, validation, and trust, not model performance, are the real challenges for AI adoption in life sciences.

Software Solutions & ServicesMay 13, 2026 4 min

Why AI Is Too Generic for Regulatory Conversations in Life Sciences

Discover why AI governance in life sciences depends on intended use, risk context, and control frameworks rather than the AI label itself.

ClinicalMay 13, 2026 5 min

Structural Heart and Coronary Trials in Europe: What Can Go Wrong

Discover the most common operational and regulatory pitfalls in structural heart and coronary trials across Europe, and how to mitigate them early.

ClinicalMay 13, 2026 3 min

Running Your First Structural Heart Trial in Europe: What to Expect Before You Start

Discover what non-EU sponsors should expect when launching a first structural heart or coronary device trial in Europe under the MDR framework.

ToxicologyRegulatory AffairsMay 6, 2026 4 min

Bringing ERA into Practice: Key Challenges in Pharma

Discover the practical challenges of Environmental Risk Assessments (ERAs) in pharma, from toxicology input to data consistency and lifecycle management.

Regulatory AffairsMay 6, 2026 5 min

Governance in Combined Studies: Getting Roles Right Before the Clock Starts

Discover why governance and role clarity are critical in combined drug-diagnostic studies under the CTR and IVDR.

Regulatory AffairsMay 6, 2026 4 min

Why Pharma and IVD Partners Must Collaborate Earlier Than You Think

Discover why early collaboration between pharma sponsors and IVD partners is critical for successful companion diagnostic development under the IVDR.