Clinical Trial Regulatory Services

Applications when everything must go right.

Our Clinical Trial Regulatory Services team can help facilitate a seamless experience no matter where in the world you operate. By combining centralized data management with the ability to simultaneously manage multiple regulatory submissions, we can guide you through quicker trial start-up and follow-through.

We are also proud to ease your journey with labelling services in a single location. So whether you need a single label or a full library, we can work it into your full-service clinical trial management solution.

Partner for greater flexibility

Across your clinical development journey, consider our Clinical Trial Regulatory Services a hub for all. Whether you, a third party, or Parexel are managing your clinical trial, our processes and solutions are designed to bring everyone together. From your submission plan, assembly, and application management through delivery to master archiving, you’ll rest easy knowing all your assets are being managed by a single watchful team.

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From lay summary requirements to the Voluntary Harmonization Process (VHP), check out key insights about the EU-CTR. Click to learn more >

Parexel's Clinical Trials Regulation (EU) 536/2014 Advisory Services

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Preparedness for the Clinical Trials Regulation (EU) 536/2014 will require a wide-ranging cross enterprise business strategy including for both ongoing and new clinical trials to be set up correctly.  Are you ready for the change? Download our factsheet to learn more about how Parexel can help you prepare for the transition.

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Three ways to work with the FDA for better patient-focused trials

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Four reasons to conduct robust natural history studies before clinical trials

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Maximize the efficiency of regulatory operations with five key competencies

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Five competencies for operational excellence in cell and gene therapy clinical trials

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Parexel Resource Center

Browse the Parexel Resource Center for our latest content on clinical trial supplies, logistics, innovation, drug safety, cell & gene therapy, and more!

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