We work with our clients at early stage of development to identify medical needs, support them in their choice of therapeutic indication and/or medical use of their products including specific patient populations.
- Early stage medical advice for guidance in patient populations and medical needs
- Literature searches for specific medical fields or situations
- Medical writing and medical review of regulatory documents
- Clinical trial design and protocol development
- Specific patient population investigational plans (paediatric, elderly, other)
- Risk/benefit assessments for clinical trials
- Safety monitoring and safety management plans
- Medical reports, including clinical study report
Medical and scientific review of promotional and educational material.