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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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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. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy.

Trials 64
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Scopus BioPharma Announces Appointment of Additional Directors

The Pharma Data

Scopus is a biopharmaceutical company whose lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers. Dr. Russell has managed all aspects of the drug development and regulatory approval processes for oncology and non-oncology drug candidates.

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Demystifying the ICH M10 Bioanalytical Method Validation Guidelines

Conversations in Drug Development Trends

Global Impact of ICH M10 Validation Guidelines Harmonization of bioanalytical validation methods is crucial in a world where pharmaceuticals are developed and approved across different regions. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

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The Power of Bespoke Hybrid FSP/FSO Solutions

PPD

Often, however, a hybrid use case will fit into one of these general categories: 1) An existing FSO arrangement needs additional expertise or resources to support a specific study function, requiring the developer to scale or augment that FSO arrangement with FSP services.

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Trends in Oncology Study Design, from Optimus to Endpoints

Conversations in Drug Development Trends

You can learn more about biomarkers and how to use them in oncology studies in this white paper. Single-Arm Trial Design Single-arm trials have also become an increasingly common development strategy to support regulatory approval and allow patients expedited access to novel therapies, particularly in the accelerated access setting.