FDA and MHRA Say Remote and Hybrid Inspections to Continue

July, 2022

At the 2022 Drug Information Association Annual Meeting, held in-person in Chicago June 20-23, representatives from the ...

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Examining the Why and How of Integrating Your eTMF and CTMS

July, 2022

Adapted from a Phlexglobal Ask An Expert interactive discussion held May 11, 2022 and available on-demand here.  

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Sponsors Gear Up For a Smoother Process With CTIS but Must First Overcome Key Hurdles

June, 2022

Read the latest blog from our Pharmalex colleagues, Milena Shuytsova-Mircheva and Lisa Pascoe, who discuss the benefit ...

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Decision Criteria for the Next Generation of Regulatory Information Management (RIM) Systems

June, 2022

Adapted from a Phlexglobal webinar, “The Next Phase of Intelligent Regulatory Process Automation,” held April 20, 2022 ...

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The Future of the TMF Reference Model

June, 2022

Adapted from a Phlexglobal Ask An Expert interactive discussion, “TMF Reference Model Q&A,” held April 6, 2022 and ...

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How Quality Review and Heatmaps Can Reduce Remediation Time, Cost, and Effort for an Acquired Trial Master File

May, 2022

Adapted from a Phlexglobal Ask An Expert interactive discussion, “How to Ensure TMF Inspection Readiness & ...

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