Early Phase Development Solutions

Drive your molecule’s success with the help of a team of experts committed to advance your program through critical milestones.

Partnership. Continuity. Value.

  • Leverage world-class drug development experts 

  • One focused team for your early drug development journey 

  • Make more informed business decisions

file
Your Needs

Start with the end in mind to make smarter decisions—at every stage.

With so many critical decision points in the drug development process, increased insights into early drug development efficiencies can help you uncover potential risks and opportunities, and efficiently answer the increasingly sophisticated set of questions that arise:

  • How do I identify issues early allowing me to make adjustments without losing time or money?
  • How do I demonstrate that my compound will be commercially attractive?
  • Is this the best regulatory strategy to mitigate risk?
  • How do I align my nonclinical plan with my clinical endpoints?

From the very beginning, we work with you to proactively identify the right strategy based on your unique program. With flexible solutions and on-time execution, you’ll receive continuous support to overcome uncertainties and reach your critical decision points, faster.

Scientific and operational continuity—from the very start.

Continuity is vital to the success of your program. Early Phase Development Solutions provides you with direct access to a focused team of nonclinical, clinical and regulatory experts that will remain with you throughout your program and help deliver a unified, consistent data package to set you up for success. 

Flexible solutions to match your unique needs.

Partnering with Covance for Early Phase Development Solutions doesn’t mean you’re locked in. Our flexible approach to contracting provides you with optimal options, such as study-by-study or targeted milestones, all with guaranteed deliverables to meet your unique financial needs. It’s just another way we work together to maximize your asset’s value—and your bottom line.

Our Capabilities

Your drug development strategy

The success of your drug development program starts with your compound’s unique overall strategy. With our experience in partnering with more than 500 biotech companies per year, you have instant access to a focused team of experts that can help you build a strategy to de-risk your program and add value to your asset. 

Which candidate is best?

Get integrated solutions to rapidly 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. 

IND/CTA-enabling nonclinical safety assessment

Leverage the knowledge of a team who manages programs that support hundreds of regulatory submissions per year.  This enables you to seamlessly integrate the complete array of nonclinical services, including lead optimization, safety pharmacology, toxicology, pathology, bioanalytical, drug metabolism and pharmacokinetics, to assure successful design and conduct of your program—all the way through IND/CTA submission.

First-in-Human (FIH) Studies

With Early Phase Development Solutions, you benefit from the retained knowledge from nonclinical study results and interpretation of potential findings to move your compound across phases more effectively. The focus will be on two critical aspects of your FIH studies: scientific integrity and human subject safety. As early research continues to demand more complex studies requiring special populations, multiple endpoints and adaptive protocol designs, you’ll leverage our more than 35 years of insights and industry-leading human AME expertise. 

Proof of Concept (PoC)

Waiting until you have a complete data package before designing your PoC (Proof of Concept) study can waste time. Instead, take innovative approaches to these shorter, scientifically demanding studies by parallel processing study feasibility and site assessments, incorporating relevant biomarkers and leveraging adaptive trial designs. Increase your clinical ROI by applying the right level of medical, scientific and therapeutic expertise resources and patient stratification strategies to your program.