Services* (you can select multiple choise)
—Seleziona un'opzione—Drafting protocolPreparation of SynopsisSample Size calculation and Statistical AnalysisBudgeting and Patients Fee calculationsSites Feasibility and Sites SelectionContract Reseach Organization (CRO) selectionSelection of laboratoriesStipulation of InsuranceData management Plan DesigneCRF designRandomization List generationData Safety Monitoring Board (DSMB) or Clinical Events CommitteeStudy email and website (optional)STATISTICAL PLAN DesignMonitoring Plan DesignQuality Plan DesignValidation Plan DesignRisk management analysisKick Off MeetingRegistration of the study on clinicaltrials.govTMF preparation and ISF preparationPreparation of Documents and Dossier to submit to EC/CA and applying for Research Ethics Committee OpinionApproval from Competent Authority (CA) (for pre-market studies)Notification to Competent Authority (CA) (for post-market studies)Contract NegotiationInvestigators’ meetingsGood Clinical Practice (GCP) Training and Curriculum Vitae (CV)SIV preparationIP ManagementNotification of first enrolment to the ECData ManagementData entryRemote and On site MonitoringAmendmentsIP AccountabilityGAP AnalysisNewsletterPreliminary or Interim ReportDSMB and CEC OrganizationMeetings with CROInvestigator meetingsCOVClinical Study ReportStatistical analysisDatabase lockData cleaningArchiving

Study Type: InterventionalObservational

Sponsor: ProfitNon-Profit

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