| STRATEGIC SERVICES |
Application of a Strategic Approach to Your Development Programme
will Aid in Ensuring that Your Company's Regulatory and Commercial
Objectives are Achieved with Maximum Efficiency and Rigour
will Aid in Ensuring that Your Company's Regulatory and Commercial
Objectives are Achieved with Maximum Efficiency and Rigour
We can assist with defining the clinical development pathway from first-in-man studies through to the value-adding stages of out-licensing or registration. We can also assist with interactions with key opinion leaders to define the target product profile and to design the appropriate clinical trial(s) to support your Company's regulatory and/or commercial objectives.
Services include:
- Clinical development plans for new chemical/biological entities
- Clinical trial design
- Project plans & timelines
- Project management of multidisciplinary project teams
- Co-ordination of market/commercial assessments
- Tailored information packages – technical & non-technical (commercial, regulatory agency, marketing)
- Establishment and management of Clinical Advisory Boards
- Co-ordination of pre-IND meetings & information packages
- Preparation of R&D funding proposals