Services
IND-Enabling Toxicology Programs That Pass FDA Review
Avoid the 60% of IND submissions that receive FDA clinical holds due to inadequate preclinical toxicology. RSS designs and manages comprehensive tox programs that regulatory agencies approve on first submission
Gene Therapy with Intravenous and Direct Deposition
Navigate the complex regulatory landscape for gene therapy products with an expert who's managed multiple gene therapy preclinical programs across multiple delivery routes.
Data Analysis
RSS can derive data either from digital waveform recordings or paper tracings and provide data summarization and descriptive statistics. RSS is proficient with data aquisition systems (Pohnemah, EMKA, Notocord) and can also do some a basic statistical analyses (SigmaPlot, GraphPad)
Laboratory Animal Medicine and Surgery
RSS is also highly experienced in laboratory animal medicine and the Director has served as Attending Veterinarian at several pharmaceutical companies and in academia. RSS can provide surgical guidance in vascular access ports/buttons, telemetry data collection, various vascular modifications, in vivo tissue sample collections, and vivarium management
Our Scientific Journey
Meet Dr. Michael Stonerook: Your Preclinical Success Partner
Rook Scientific Services is a consulting firm providing specialized scientific solutions across various preclinical study designs and drug development packages.
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Michael Stonerook, PhD (physiology), DVM, DABT has participated in many roles during his career including Attending Veterinarian, surgical veterinarian, study director for safety pharmacology studies and general toxicology studies (GLP and non-GLP), production of IND packages, and manager/director of research groups. With 20+ years navigating pharmaceutical regulatory requirements, Dr. Stonerook has helped dozens of companies successfully transition from discovery to clinical development. His unique combination of veterinary medicine expertise, toxicology board certification, and hands-on pharmaceutical industry experience makes him the go-to consultant for complex preclinical programs.