Phase I hybrid trials are early clinical studies combining both healthy normal volunteers (HNVs) and patients from the target indication in one protocol. These trials can be extraordinarily valuable, as they can deliver important insights regarding a drug's pharmacodynamic (PD) effects and therapeutic potential at a very early stage in development.

Using a cGMP pharmacy at your Clinical Research Unit (CRU) for Phase I drug manufacturing yields benefits in quality and safety, timeline reduction and cost efficiency.

Labcorp data can help accelerate your studies. Labcorp data is comprised of four powerful data sets: Labcorp De-Identified Lab Result Data, Labcorp Central Labs Investigator Data, Patient Direct and Patient Intelligence.

The landscape of early drug development has changed radically over the last decade. The norms of the past, wherein first-in-human (FIH) studies consisted of a relatively straightforward series of observations following administration of small molecules to normal healthy volunteers, have given way to exponential increases in complexity.

Get access to a rapidly growing database of people who have given permission to be contacted directly for participation in clinical studies. Over 16,000 gastroenterology patients included in our global database deepening our insights to make your studies more efficient.

Over 16,000 autoimmune patients included in our global database deepening our insights to make your studies more efficient. Our surveys collect information on a wide variety of variables for each patient. Compare different populations of autoimmune patients.

Not all data is created equal. Leveraging our proprietary data enables us to deliver strong, viable protocol designs, faster patient recruitment and fewer non-performing sites than the industry average.

Eighteen biosimilars were approved by the FDA through the 351(k) pathway as of the end of March 2019, but the regulatory pathway in the U.S. is still considered a new frontier, especially when compared to regulatory guidance in the EU.

It can be a challenge to stay on top of the ever-changing regulatory landscape when looking to re-register or take a new chemical to market.