Advancing a new molecular entity from lead identification to initial clinical evaluation is a major challenge. Tight timelines and limited budgets only make matters more difficult. As if that's not enough, identifying the appropriate preclinical studies — with their diverse scientific disciplines and regulatory requirements — can strain your resources to the breaking point.

Covance Program Management Services can alleviate this pressure and help you achieve your drug development goals by acting as your tactical, logistical and scientific interface with our global drug development resources.  Focusing on your development goals, our team will tailor an integrated development plan that is flexible and responsive to your needs. We have over 20 years of experience managing and optimizing hundreds of integrated programs from late discovery to Phase I and IIa development with seamless transition to late stage clinical development.  Over the past three years our Program Management team has enabled our clients to submit more than 120 IND/CTA applications.

IND/CTA-enabling Services

A well-designed development strategy is crucial to the success of a drug candidate. As new drugs proceed into development, Covance's Program Management team works with you to develop a cost-efficient strategy to address key safety and regulatory issues, and enable clinical testing in human volunteers.

Covance Program Managers are a dedicated full-time staff of experienced scientists who can help you customize your drug development strategy. Program Managers integrate the complete array of IND/CTA-enabling services, including safety pharmacology, toxicology, pathology, drug metabolism, pharmacokinetics to assure successful design and conduct of your program.
Nonclinical services

First-in-human services

A critical milestone in drug development is initiation of a first-in-human clinical trial. Your Program Manager's knowledge of your molecule's nonclinical disposition and safety assessment provides a critical link to enable the development of a robust Phase I protocol.

With access to our Global Clinical Research Units located in the US and Europe, your Project Manager can schedule your first-in-human study to coincide with regulatory approval. Each unit is staffed with physicians, clinical pharmacologists, project managers, clinical research associates and data managers to assure the timely execution of your study protocol.
Clinical Pharmacology Services

Phase IIa proof-of-concept services

Once you have completed first-in-human studies, proof-of-concept studies may begin. These studies are conducted under controlled conditions in a small population of target patients to demonstrate efficacy of a new drug.  Our Program Management team will help you transition your compound into Phase IIa. You will have access to our clinical and pharmacometric staff for study design and conduct, to our bioanalytical staff for correlating PK/PD parameters and to the capabilities of Covance Central Laboratories for safety monitoring.
Early Patient Clinical Studies