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Clinical Trial Start-Up

We coordinate the preparation and review of the necessary documentation to start a clinical trial in any center across the Iberian Peninsula, from early development to Phase IV, non-interventional trials, investigator-initiated trials, clinical investigations with medical devices and projects.    

We submit authorization to the Iberian Peninsula competent authorities and manage the required permits / contracts in the shortest possible time. FTH expertise is provided for our clients’ service at this vital stage in Clinical Management.

Start-up activities include:

  • Design and Elaboration of the Protocol

  • Design and Elaboration of Informed Consent sheet 

  • Feasibility Activities to assess Site Suitability

  • Electronic Investigators Network (EIN) in Diverse Therapeutic Areas

  • Preparation of the Patient Log / Manual

 

  • Submissions to IEC / IRB and Follow-Up

  • Regulatory Procedures with Competent Local, Regional and/or International Authorities

  • Negotiations of Contracts and Budgets

  • Management of the study in public databases: REec y clinicaltrials.gov