Services
Planning phase
- Design and implementation of customized quality assurance programs
- Expectations assessment
- Subjects recruitment strategies
- Design et drafting of regulatory forms and reference manuals
- Identification, qualification and recruitment of investigators and sites
- Pre-study sites visits
- Management of site-specific regulatory documentation
- Preparation and conduct of site initiation visits
Conduct phase
- Proactive subjects recruitment
- Technical review of clinical data
- Proactive process management of data clarification request (queries)
- Management of deadlines
- Management of study supplies
- Management of investigator compensation
- Continuous evaluation of sponsor satisfaction
Evaluation phase
- Preparation and conduct of site close-out visits
- General summary of services rendered and results obtained
Ongoing
- Coaching and mentoring
More details will be available upon request.
Last update: 02Apr2010