ECLINICAL INSIGHTS
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The Placeholder Debate: Why Teams Love (And Hate) This TMF Tool
What is an eTMF placeholder? Why do some love it and some hate it? ICE Consulting's Suzanne Turner explains why there's such debate over their usefulness.
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Integrating QMS And eTMF For Proactive Clinical Trial Quality
In today’s clinical trial landscape, where complexity is the new challenge, integration is not optional: QMS defines quality, and eTMF proves it.
CTMS RESOURCES
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Starting a new clinical study requires careful vendor selection and these practical, actionable steps to enhance your selection process and ensure long-term partnership alignment.
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Automation has become an essential tool for addressing the inefficiencies in traditional clinical trial methodologies, enabling trial teams to instead concentrate on critical tasks such as patient care.
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As Gen AI develops and reaches advanced stages it introduces risks such as model hallucinations, which can affect trial accuracy and reliability. Explore how to address these challenges.
EDC RESOURCES
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Switching solution providers mid-study isn't uncommon. But how can teams avoid schedule delays, interrupted operations, and errors? Learn best practices from this example by Signant Biotech.
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Kronos Bio discusses how their oncology biotech switched to Vault EDC for faster, more flexible builds.
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Learn how to automate the flow of Serious Adverse Event (SAE) information between data management and safety systems, enabling more timely responses by Pharmacovigilance (PV) teams.
ETMF RESOURCES
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Most unauthorized data breaches enter through doors that already exist. Learn how role-based access can improve security by tailoring access to each user’s needs and responsibilities.
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Assess five common pitfalls trial teams face when incorporating new technology and identify potential solutions to mitigate the common risks.
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Utilize this summary of key tips, checklists, and lessons learned to mitigate the risks and efforts associated with migrating a trial master file.