Clinical Trial Management

Clinical Trial Management

Service offered :-
  • Confidentiality Agreement (CDA) development
  • Investigator Briefing Package and Feasibility Questionnaire (FQ) development
  • MedClinica Feasibility Database search and initial selection of sites for the feasibility study
  • Obtaining executed CDAs and completed FQs
  • Conservative re-assessment of sites’ patient pools and enrollment projections
  • Assessment of regulatory feasibility
  • Feasibility Report writing
  • IRB/IEC and Competent Authorities approval
  • Site’s contracts and investigator’s fees set up, negotiation and execution
  • Translations
  • Import/Export License management
  • Insurances
  • Feasibility strategy set up based on previous experience and country / site specific analysis
  • Identification and selection of sites and investigator’s according to study protocol requirements and target patient’s population
  • Coordination of investigator meetings, including all applicable logistics
  • Direct Staffing and training of Study Site Coordinators where required
  • Overall study start-up delivery: (Sites agreements, IEC / IRB and Competent Authorities submissions, Import /Export license, Translation, Insurances)
  • Initiation and ongoing monitoring of investigational sites according to applicable local and international regulations
  • Ensuring appropriate support to sites staff for optimised data integrity and accelerated patients recruitment
  • Site closure activities including document management and supply reconciliation and destruction/shipment
  • Pre-study activities
  • Study initiation activities
  • Study Conduct activities
  • Study Closeout activities
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