Pre-Clinical Phase

Prepare your vision

Assess whether a drug candidate is ready for human testing with analytical analyses and laboratory support. From pre-clinical safety evaluations and toxicology to clinical trial planning, we many options and capabilities to support your decisions in a confident manner. Our planning solutions will help you align operationally, design effective clinical trials and advance candidates.

Seeking Ways To Ensure Participant Safety In First-In-Human Trials

Learn about regulatory guidelines for first-in-human trials.

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Key Strategies for Speeding Time to Clinic

Getting to First-in-Human Clinical Trials: A make-or-break milestone for small biopharmas.

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Writing Guide for First-in-Human Trials

Reference this checklist to help you draft phase-appropriate chemistry, manufacturing, and controls (CMC) modules for the common technical document (CTD).

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Gain access to robust lab support, tailored study design, regulatory consulting, epidemiology research and more, including:

A wide variety of bioanalytical laboratory capabilities
Preclinical dosage, toxicology, PK/PD and safety testing
Pre-IND/IND support

FDA or EMA filing support and representation
Clinical trial development, design and methodology
CMC consulting for all types of pharmaceutical products

Pre-clinical resources

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Proceed with conﬁdence as you test and optimize your lead candidate to prepare for the clinical trial phase. Whether you’re preparing study data for IND ﬁling or developing a CMC strategy, browse solutions driven resources to simplify and accelerate your work.