Early Phase Clinical Trials
Navigating 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.
The dedicated team of PPD global experts in early development and clinical pharmacology performs a critical assessment of your compound’s unique attributes to identify areas of strength and potential weakness that could impact the outcome of your current and subsequent trials. 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.
Ensuring patient diversity in clinical trials
Inclusive research solutions curated to meet your needs at every phase of drug development.
Helping our clients navigate their Phase I-IB studies
PPD’s early development services keeps an eye toward supporting your later-phase programs.
Phase I studies conducted in the past five years.
Households in our patient database.
PPD’s Early Phase Development
and Clinical Pharmacology solutions
Our streamlined services help establish proof-of-concept by reducing time and cost from your development timeline.
Early phase CRO services
Phase I clinical trial capabilities
First-in-human studies are demanding and multidimensional, requiring a finely tuned balance between scientific rigor, patient safety, regulatory requirements and market access strategies.
Orchestrating these disparate elements requires an experienced and dedicated team of experts who collaborates to inform, advise and execute your Phase I studies. Our dedicated Phase I professionals customize solutions to fit your unique compound, business model and study objectives.