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Early Phase Clinical Trials

Phase I and IB trials represent the first practical tests of your compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives.

Maximizing success in early phase development requires a highly coordinated effort to anticipate potential challenges, recruit the right patients, engage top investigators and design a trial that will build a platform for later-stage success.

PPD’s dedicated team of global experts in early development and clinical pharmacology perform a critical assessment of your compound’s unique attributes to identify areas of strength and potential weakness that could impact the outcome of your trial and subsequent trials. Next, the team develops an integrated, early-phase program that leverages our facilities, site network, operational expertise and development experience to execute your trial in patients and/or healthy volunteers. Each step of the process is conducted with an eye toward supporting later-phase programs and regulatory submissions.

We customize solutions to fit your compound, your business model and your study’s objectives. PPD’s early development services provide: 

Three state-of-the-art clinical research units (CRUs) located in Austin, Texas, Orlando, Florida and Las Vegas, Nevada, where integrated teams of investigators and clinical research experts support a range of studies in both healthy volunteers and patient populations.
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A dedicated team of early development professionals whose sole function is to plan and execute Phase I and IB trials that accelerate your trial and contain costs.
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Access to a global network of early-phase research sites that conduct studies in general and specialty populations.
Unprecedented access to global patients via Accelerated Enrollment Solutions (AES), PPD’s industry-leading patient recruitment engine.
A range of consulting services for asset planning in the earliest phases of development and regulatory strategy assessment to mitigate risk.
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PPD Laboratories’ comprehensive set of lab services designed to support early phase trials including customized assays for drug product evaluation as well as bioanalytical and pharmacokinetic assays.

In the past five years, we have conducted more than 340 studies involving more than 10,000 patients and healthy volunteers.

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Early Development and Clinical Pharmacology Solutions Brochure

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