Pre-Clinical - Support through Pre-Clinical Phase

Supporting your pre-clinical phase

Determine whether a drug candidate is safe for human testing with laboratory and study design support, regulatory consulting and FDA guidance. From pre-clinical dosage, toxicology and safety analysis to clinical trial design, ﬁnd what you need to have conﬁdence in your results. Explore capabilities, case studies and ﬁnd additional resources to help you excel throughout this critical step.

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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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.