Preclinical Consulting
Providing expert guidance in the critical first stages of the pipeline, DataRevive ensures you have defined the optimal preclinical strategy to streamline the entire process through to pre-approval GMP inspections – ultimately yielding a more efficient and positive result.
DataRevive enables you to maximize your product’s success potential by designing PK, PD, and toxicology studies that accurately model desired biological effect, efficacy, and toxicities while also conforming to the expectations of regulatory authorities. From data review to the composition of regulatory submissions, DataRevive’s preclinical services span the gamut of your needs and include:
- Phase-Specific Strategy Guidance & Gap Assessment
- Preclinical Strategy/Program Design, including:
- GLP Toxicology Studies
- GLP PK Studies
- Non-GLP Pharmacodynamics Studies
- Protocol and Report Review for PK/PD/Toxicology
- Study Report Composition, Review, Authorization & Results Interpretation
- PK/PD Modeling
- IB Writing & Preparation
- Nonclinical Study Report Translation (Chinese/English)
DataRevive’s esteemed preclinical team averages 20+ years of experience supporting novel drug discovery and development and includes a Nobel Prize laureate. These consultants work hand-in-hand with clients like you to provide their experienced insights and the strategic oversight needed to optimize regulatory interactions and submissions at every step.
