07.25.25 -- Outsourcing Everything But The Responsibility Under ICH E6 (R3)

Without teamwork, the best solutions still fall short. Unlock your clinical data's potential and transform chaos into clarity by starting with clear questions, adapting to insights, and fostering collaboration.

This report offers a view on implications for biopharma and the wider healthcare ecosystem and identifies actions to continue to shift towards transparent, trusted, and transformational clinical trials.

How can an effective partnership help you to utilize advanced data analytics to address the significant challenges of clinical trials centered around ultra-rare diseases?

Enabling sites to focus solely on critical data facilitates faster data entry, reduces queries, and fosters better relationships between sponsors, CROs, and sites.

Address inconsistent assessment scoring that masks treatment effects and inflates placebo responses while delivering cleaner endpoint data through standardized scale administration.

Learn about a sophisticated suite of pharmacokinetic (PK) and pharmacometric services designed to accelerate and optimize early-phase drug development.

ICH E6 (R3) advocates for a streamlined, risk-informed trial design that enhances quality and participant experience, paving the way for more efficient and successful clinical research outcomes.

Ergomed ensures the highest data integrity and patient safety standards through risk-based clinical monitoring and SDV practices. SDV ensures the data collected are accurate, complete, and verifiable.