Services Overview

Clinical Trials

Regulatory

Medical & Pharmacovigilance

Nonclinical Safety

Data Management & Biostatistics

Chemistry, Manufacturing and Controls

Medical Writing

Quality Assurance

Project Management

Investigator Registry

Services: Medical Writing

Our statisticians, scientists, and physicians collaborate to provide high quality integrated clinical and statistical reports to provide a comprehensive overview of the trial and an integrated analysis of the clinical trial data. Our ICH E3-compliant report format was developed to facilitate review by regulatory agency personnel and includes in-text tables, figures, and convenient summaries that are suitable for use by the FDA in the preparation of FDA reviewer documents. Of note, numerous sponsors and FDA representatives have complimented Cato Research on the high quality and clarity of presentation of the clinical study reports produced by our project teams.

Cato Research medical writers are experienced PhD-level scientists who prepare protocols, investigators’ brochures, and other study documents in addition to study reports. For all deliverables, Cato Research executes a detailed, three-step document preparation and review process that facilitates the production of high-quality technical reports.