Whitepapers

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 More
Achieving 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 More
Essential 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 More
Hindsight 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 More
Implementing 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 More
Trends 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 More
Strategic 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 More
Future 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 More
Defining 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 More
Finding 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.

Read More