Drug Development Program Management Services
We understand that the success of your development program is not based solely on a collection of study results, but also by the decisions made between studies.
A team of professionals dedicated to program management
More than 20 years of experience managing integrated drug development programs
Successfully filed more than 120 IND/CTAs in the last 2 years on behalf of our partners
A partner in the journey.
Powerful decisions are driven by insights; insights are gathered from experienced interpretation and the ability to connect the dots between the outcome of one study and the implications for the next. Our experienced team of program managers will guide you through your studies, and the decisions you need to make between studies, to reveal opportunities for your program, maximizing your ROI along your development journey.
Relentless focus on your strategic outcomes.
Whether your goal is to bring your molecule through commercial approval or to divest at the appropriate point of development, our dedicated team of experts connects you to insights that will maximize the potential of your asset. We see the drug development process as a series of objectives, and manage programs to efficiently meet each of them in a timely fashion.
Fluency in multiple languages, especially yours.
Engage with experienced scientists who offer a broad range of drug development expertise in efficacy/lead optimization, toxicology, metabolism, CMC, clinical development, as well as regulatory strategy and submissions for any compound or indication. We understand the process holistically, so we can effectively work with you on a high-level strategy. Once initiated, your program manager will communicate program status through collaboration, reports and daily interaction with you.
Defining your unique journey.
The drug development journey is riddled with questions. How you answer them determines your unique pathway towards approval.
- Is the therapeutic target or disease pathway validated?
- Can we identify a lead candidate?
- Can we develop the lead candidate?
- Is it safe to give to humans?
- Does the drug work in human clinical conditions?
Our program managers are relentless in helping you answer these questions to efficiently progress your program towards your desired destination.
Destination: Candidate Selection
Our program managers develop integrated strategies to help you identify and develop your best lead candidate. From early characterization and formulation on development batches, to non-GLP screening for early identification of pharmacology — or toxicity-related issues — we can help you move your best candidates forward.
Our program managers seamlessly integrate the complete array of Covance nonclinical services, including lead optimization, safety pharmacology, toxicology, pathology, drug metabolism and pharmacokinetics, to assure successful design and conduct of your program — all the way up to and through IND/CTA submittal and/or approval.
Destination: First-in-Human Trials
With access to our global Clinical Resource Units, your program manager schedules 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 ensure the timely execution of your study protocol.
Destination: Proof-of-Concept Trials
Our team of program managers helps you transition your compound into Phase IIa. We connect you to our clinical and pharmacometric staff for study design and conduct, our bioanalytical staff for correlating PK/PD parameters and to our Central Laboratories for safety monitoring.
Whatever your destination, with a Covance program manager as your partner, you’re set up for success.