The Importance of GCP and GMP Audits to Verify Clinical Trial Compliance
Auditing is an essential element and key function within clinical trials, helping companies ensure patient and product safety, avoid gaps in compliance and prepare for regulatory inspections. In this white paper, we examine the key steps in audit performance – planning, preparation, conduct, reporting, follow-up, and closure – outlining the differences and similarities in process and scope of review between GCP and GMP-focused audits.
Read MoreAchieving Inspection Ready TMF Quality: The Four Cornerstones
Despite the increase in eTMF utilization, Health Authority attention and sponsor awareness, TMF Quality continues to be an issue for many organizations. Issues in TMF Quality are driven by many factors, including the complexity of today’s trial protocols, frequent change in outsourcing models, and the use of new eClinical systems, to name a few. In this white paper, we will discuss how it is possible to attain TMF Quality sufficient to withstand health authority inspection by thoughtful and deliberate management of four key TMF cornerstones.
Read MoreEssential Soft Skills for Quality Leaders: Learnings from the COVID-19 Pandemic Response
This white paper examines the soft skills that are beneficial in the development of a well-rounded quality thinker and professional.
Read MoreHindsight is 20/20: Effective Pharma-CRO Quality Partnerships in Turbulent Times
This white paper provides insights into the skills & tools that build strong pharma-CRO partnerships, & common misunderstandings that can lead to strained relationships.
Read MoreImplementing ICH E6 (R2) and Planning for E6 (R3)
This white paper describes lessons learned during the organizational implementation of E6 (R2) at Advanced Clinical, examining operational hurdles, solutions & results.
Read MoreTrends in Immuno-oncology: Meeting clinical trial and market access challenges
Learn how immuno-oncology therapies are being used today and where it needs to be tomorrow.
Read MoreStrategic Resourcing Using a Functional Service Provider (FSP)
Learn how FSPs offer a valuable solution to the talent shortage dilemma in this white paper by our Strategic Resourcing experts.
Read MoreFuture Trends in Clinical Trials: Looking Ahead to the Next Decade of Innovation
Explore what the future holds for clinical trials and how the process could evolve. Download the whitepaper now.
Read MoreDefining the Computer Systems Validation (CSV) Lifecycle: Four Foundational Components Supporting Your Clinical Trials
Take a closer look at how four areas define the overall CSV lifestyle. Download the whitepaper now.
Read MoreFinding the Right Technology for Your Clinical Development Plan
Learn how to identify the EDC capabilities needed for your clinical development plan. Download the white paper now.
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