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Blog: How Clinical Operations Can Accelerate Through De-risking Clinical Trials

Advances in clinical trial design and technology are significant contributors to medical progress. However, they also hamper clinical operations and data management professionals’ understanding of risk. While clinical trial innovations result in increasingly diverse data sources and study types, this diversity also brings additional concern about patient safety and data quality.

Fortunately, this gap between advancement and increased patient risk was not unnoticed by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the E6(R2) Guideline for Good Clinical Practice (GCP) is undergoing revision. Last revised in November 2016, GCP is a standard that guides the world’s most preeminent regulatory bodies including but not exclusive to the United States Food and Drug Administration and European Medicines Agency. Through the adoption of new GCP guidelines, organizations can develop drugs and therapies on the forefront of science while minimizing risk and maintaining quality.

The new guideline, denoted as ICH E6(R3), is scheduled for completion in August 2023 and they shared a work plan issued in July 2021. Due to the increase in innovation available to clinical operations teams, the new guidance is expected to address a broader range of studies and data sources.

Great Idea, Harder Practice: GCP Remains Difficult for Some Clinical Operations Teams

While GCP guidelines are an important standard for the industry, some life sciences organizations struggle to meet the standard. Small and midsize companies, with less operating capital and smaller teams, often use home-grown solutions to manage risk which leaves them scrambling through spreadsheets and various other documents to gain insight on risk.

But why? Both time constraints and budgetary concerns hamper finding a solution to meet GCP guidelines. However, spreadsheets and home-grown solutions are not up to the task of meeting clinical operations team requirements resulting in costly delays and elevating risk for study startups.

There is a better way to identify and manage clinical trial risk.

Finding a True Solution for Clinical Teams

The world of software has grown exponentially and thus, more available to organizations. Utilizing a modern Clinical Trial Management Systems (CTMS) is easier than ever before and accessible to organizations of all levels. A CTMS that includes advanced frameworks for making decisions about risk also makes it easier to meet GCP guidelines both new and upcoming, empowering clinical operations teams and clinical data to better anticipate risk.

A CTMS system pushes for better cross-functional collaboration between data management, clinical operations, and others to ensure additional risk identification. A CTMS offers a framework to help answer key questions, such as:

  • What risks do we have?
  • How large are the risks?
  • How can we reduce risks?
  • How well can we detect if things go wrong?
  • If they do, how will we respond?

With a CTMS using this framework, clinical teams can uncover hidden study risks with industry standard questions, and score study risk based on likelihood, impact, and detectability. The result is a more air-tight risk plan that makes for a stronger clinical study report.


Cross-functional Collaboration Creates Stronger Clinical Teams

Using a modern CTMS with this framework built in, teams of functional leaders work with a project manager to proactively identify critical risks that may affect trial quality or participant safety. From there, they create cross-functional plans for mitigating risks. Collaboration creates a cohesive environment with clear communication, visibility across the trial, and mitigates risk in expensive clinical trials. CTMS systems are more accessible than ever before to organizations of all sizes.

Learn more about how CTMS systems can help clinical teams identify and manage risk via view this webinar and how a this can help teams reduce cost, ensure safer clinical studies, and empower teams to do more.

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