Thought Leadership


The Fallacy of the Corporate Memory Concept

The article challenges the concept of “corporate memory” within large CROs, arguing […]

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Do You Take Comfort In Governance Agreements

The article delves into the limitations of governance agreements with large CROs, […]

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Keys to Successful Risk Management in Clinical Trials

Risk Management in Clinical Trials

The article emphasizes the critical role of comprehensive risk management in clinical […]

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Natural History Studies in Gene Therapy Trials: Benefits, Timing and Execution

Natural history studies (NHS) in gene therapy trials are essential for understanding […]

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Diverse Mentorship Models Create Multiple Paths To Employee Success

Mentorship models create multiple paths to employee success by fostering deeper, more […]

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Quality Control in Medical Writing: What It Means and Why It Matters

Quality Control in Medical Writing: What It Means and Why It Matters

The article discusses the critical role of quality control (QC) in medical […]

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Evolving Trial Master Files Require Experienced TMF Resourcing

Evolving Trial Master Files Require Experienced TMF Resourcing

This blog post highlights the challenges inexperienced individuals face in maintaining a […]

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Shifting the Approach: 4 Strategies for ICH E6(R3) Implementation

Shifting the Approach: 4 Strategies for ICH E6(R3) Implementation

Implementing the ICH E6(R3) guidelines requires organizations to adopt a proportionate approach […]

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Gap Analysis and Collaboration Lead to Success

Gap Analysis and Collaboration Lead to Success

Conducting a comprehensive gap analysis and fostering collaboration within your organization’s quality […]

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The Critical Role of the Medical Monitor In A Clinical Study

​The Medical Monitor plays a crucial role in clinical trials, primarily ensuring […]

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