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An overview of recent projects illustrates the range of services available.
If you don’t see what you want, ask!
Drug Development
- Review pre-clinical pharmacological and toxicological data
- Provide medical and scientific input into drug development plans and study design
- Assess products for in-licensing
- Assess the potential utility of products in pre-clinical development
Clinical Trials: from first entry to man to marketing authorisation application
- Represent client at steering committee and investigator meetings
- Advise on study design
- Write and review protocols, statistical analysis plans, clinical trial reports, investigator brochures
- Provide cover as Principal Investigator or Medical Adviser
- Review coding of adverse events, diseases and medication
Regulatory Affairs
- Write relevant sections of CTD, Clinical Expert Reports, Summaries of Efficacy and Safety
- Prepare response to regulatory concerns
- Write clinical sections of CTX / IND
Other Services
- Interim management
- SOP review / revision
- Business development
- Technical writing: abstracts/posters/papers for publication; literature searching
- Teaching: seminars and lectures
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