What we do
Our services include, but are not limited to:
- Study protocols
- Clinical study reports (Phases I to IV)
- CTD clinical summaries and overviews
- Investigator brochures and updates
- Clinical trial registry and database summaries
- Quality control checks of clinical documentation
- Clinical trial authorizations/investigational new drug applications
- Non-clinical reports
We have been involved with successful registrations in Europe (EMEA) and the United States (FDA) across a wide variety of therapeutic areas.
We have links with the Evidence Research Unit, another specialized division within the Complete Medical Group, who have expertise in interpretation and analysis of health outcomes and economic data from clinical studies.
We have a sound understanding of current and emerging regulatory guidelines/requirements, experience in a wide variety of therapeutic areas and in-depth knowledge of non-clinical and clinical data evaluation, medical statistics and pharmacokinetics. This, combined with our quality control procedures, enables us to produce high-quality documents that meet your exact requirements.