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
