To pharmaceutical companies we offer services related to phases I-IV clinical research conduct.
ClinStart executes and manages all the clinical operations required to get trials up and running as efficiently as possible.
The new area of risk management requires the ability to identify safety signals from all sources. The rapidly growing demand for post-approval studies led us to single out a dedicated Post-Approval Study Department familiar with the nuances of late-phase studies.
Operations carried out by ClinStart in collaboration with pharmaceutical companies:
- feasibility and capability analysis
- support in site selection
- administrative preparation of sites selected in terms of their research potential, equipment base and experience – pre-study visits and classification of research centers in accordance with ICH GCP
- provision of required training for study team (GCP training),
- carrying out actions and procedures required for study start-up
- completion of essential documents for study registration,
- preparation of registrations/submissions,
- EC/RA submission,
- liaison with Regulatory Authorities and ethics committees
- monitoring – initiation, monitoring and close-out visits, follow-up and support in running studies (Rescue Team)
By offering services to pharmaceutical companies ClinStart guarantees:
- experience in communication with Regulatory Authorities and submissions to ethics committee
- excellent knowledge of EU directives and Polish law in the field of clinical research
- up-to-date information about study sites and investigators
- dedicated and experienced team of professionals