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Hybrid FSP/FSO Solutions Enable Flexibility and Agility to Keep Biotech Trials On Time and On Budget

PPD

The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions.

Trials 98
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How the FSP Model Augments Biotech Sponsors’ Internal Capabilities

PPD

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions. With FSO, all tasks for a clinical trial are outsourced.

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Evolution of Clinical Operations Drives FSP Staffing Models to the Forefront

PPD

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.

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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Conversations in Drug Development Trends

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. We recently published a white paper discussing the value of proactive AME studies, best practices, and lessons we’ve learned over the years to help optimize your study.

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Trends in Oncology Study Design, from Optimus to Endpoints

Conversations in Drug Development Trends

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” You can learn more about biomarkers and how to use them in oncology studies in this white paper.

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Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

Conversations in Drug Development Trends

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

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The Power of Bespoke Hybrid FSP/FSO Solutions

PPD

Each model delivers a distinct set of capabilities to the study sponsor: In an FSP arrangement, the contract research organization (CRO) performs a specific function or multiple functions (clinical operations, pharmacovigilance, etc.) across protocols, medicinal products, a portfolio of studies or the entire company.