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How FSP Solutions Support Risk-Based Methodologies and Tech Innovation in Clinical Operations

PPD

In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.

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Patient-Centric Strategies for Successful Oncology Trials

PPD

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. Drug developers must consider ways to remove these barriers to enhance their ability to recruit and retain trial participants.

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Evolution of Clinical Operations Drives FSP Staffing Models to the Forefront

PPD

A recent white paper from the PPD™ clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years, moving from capabilities that were previously built up and maintained in-house, to the multiple outsourcing models available today.

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How to reach a fully integrated production environment by transforming labs

The Pharma Data

In order to capture and manage large amounts of data while conforming to regulations, laboratories need to transform and be digitalized by unifying data capture and providing an intuitive way of interacting with it. Develop a fully automated environment to significantly boost research efforts.

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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The workshop is also discussed in Cell & Gene here and here.