Monitoring and Coordination Services of Clinical Studies
We provide services for Phase 1, 2, 3 and 4 Studies. We have a team with vast experience in conducting clinical studies.
We provide services for Phase 1, 2, 3 and 4 Studies. We have a team with vast experience in conducting clinical studies.
Studio set up
- Feasibility of Centers and Researchers.
- Qualification of Centers and Researchers.
- Management of Agreements and Contracts.
- Research Insurance Management.
- Payment Management
Regulatory activities
- Preparation of Regulatory Dossiers.
- Management of Authorizations/Approvals Ethics Committee.
- Management of Authorizations/Approvals Institutional Committees.
- Progress Reports Ethics Committee.
- Regulatory Entity Progress Reports.
Study initiation visits
- Training for the Research Team.
- Assembling the study Binders.
- Management of Distribution of Materials and Supplies to Research Centers.
Periodic monitoring visits
- Monitoring of Source Documents.
- Monitoring of Essential Documents.
- CRF monitoring.
Closing visits of studies and centers
- Closure of CRFs.
- Management of Withdrawal of Materials and Supplies from Research Centers.
Other services
Clinical Studies - Phase I Studies
Clinical Studies - Phase I Trials
We conduct Phase I to IV Clinical Research studies with the highest quality standards. A team made up of Medical Specialists from our research units together with the team of Medical Researchers form a group in charge of developing the protocols.
View detailsBioavailability-Bioequivalence Studies
We are leaders of design, execution, and analysis of Bioavailability-bioequivalence and pharmacokinetic studies in Argentina
View detailsLATAM Pharmacovigilance
The team at FP CLINICAL PHARMA can help your company in developing a GOOD PHARMACOVILIGANCE PRACTICES PROGRAM according to your specific needs. THE GOOD PHARMACOVILIGANCE PRACTICES PROGRAM was designed as a quality system based on national and international guidelines and includes the investigation, detection, assessment, validation, monitoring, reporting and archiving of adverse events of the products during commercialization.
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