Iberian Clinical Services
Hospital & Health Care - Madrid, Community of Madrid, Spain
Iberian Clinical Services Employees
Iberian Clinical Services Details
we have more than 14 years of experience in Clinical trials; We have experience in :1. Ethic Submissionso Obtain all the documentation for Ethic Submission.o Follow up the reception of the documents by Ethic Committees.o Do the payments for Ethic Committees evaluation.o Work according Ethics Committees timelines.o Verify the Protocol translations.o Verify the Inform Consent Forms according the law requirements.o Translate to local language (galego) in Spain, translation verification.2. Translation. • Protocols.• Informed Consent.• Questionnaires • Alert cards• Patient Diary.• IVRS• Laboratory Manuals.3. Verifications4. Contract Negotiation with the sites.5. MonitoringI have experience like CRA in Spain and Portugal.I have experience in:• Different therapeutics areas.• Phase I- IV.• Pediatrics / adult.I performance all the monitoring visits from feasibility until close out visit.Feasibility:o select Sites according the protocol requirements.Pre-study Visit:o Visit the facilities of sites.o Review the study procedures and the capacities of site for develop the protocol.o Verify if site has the experience and if they have access to the patients involved in the study. Initiation Visit:o Do the Initiation Visit after Contract signature according Spanish legislation.o Training study staff.Monitoring Visit;o Visit sites after the first patient enrolled or according the monitoring plan.o Monitoring Visits according monitoring plan.o Follow up of Queries.o Pharmacy Visits due.o Visit to the Investigator team.o Investigator File up dates. o Support sites in recruitment. Close out Visit:o Communicate to Ethics Committees after each site closed. We organize Investigators meetings:
