Provision of high level strategic advice, including:
- clinical development plans
- co-ordination of key opinion leader input into clinical programmes
- definition of target product profile
- trial designs
- timelines/project plans
- budget estimates
- position papers on development strategies for consideration by Boards of Directors
Project planning, and assistance to clients with identifying internal and external resource requirements
Project management (on behalf of, or in conjunction with, the Client's development team) commencing from study design to CRO tendering, selection and management, regulatory and ethical approvals, successful trial implementation and completion, and preparation of the clinical study report
Writing and/or review of clinical protocols, clinical trial agreements and other trial-associated documentation
Clinical development input into formal pre-trial meetings with USA, German and French regulatory agencies
Involvement in the successful submission of clinical trial applications to regulators in Australia, USA, Russia, South Africa
Conduct of clinical trials in countries including Australia, UK, Europe, Russia, South Africa
Due diligence of GCP compliance of clinical data prior to corporate acquisition
Gap analyses on SOPs required for clinical research activities; writing and/or review of full set of GCP compliant clinical research SOPs
GCP compliance reviews of Sponsor and Site, and due diligence of laboratories (for P/K and specialised biological assays)
Ongoing consultancy role for NIH NIAID contract supporting a Phase I and II IND clinical development programme of a candidate microbicide gel.