Study Initiation Visit (SIV)

CliniApps experts visit the site and check for the preparedness and readiness of the site. All the relevant documents listed below are verified:

  • Ethics Committee and Regulatory Approval
  • Approved Protocol and Informed Consent Forms
  • SmPC / Product label / Investigational brochure
  • Investigational Medical Product related documents
  • Screening procedure for the subjects/ Volunteers / Patients
  • Study Meetings and Duty Delegation Sheets
  • Risk Management Plan (RMP)
  • Method Validation Report (MV)
  • Regulatory Inspection History
  • Instruction for CRF Documentation
  • Trial Master File (TMF)
  • Standard Operating Procedures (SOPs)
  • Individual Training records

Study Monitoring Visits (SMV)

CliniApps monitors visit the facility during the study conduction process for monitoring and verify the following
  • Screening Records, X-ray, ECG and laboratory reports
  • Subject IC/EC criteria and enrolment process
  • Informed Consent Form for its completeness
  • CRF data review
  • Adverse Event Reporting
  • IMP Accountability
  • Trial Master File
  • IQ, OQ and PQ and Calibration Records (IQ, OQ, PQ)
  • Dispensing of IMPs
  • Dosing of subjects
  • Study restrictions
  • Pharmacokinetic blood sampling
  • Protocol violations/deviations

Study Close Out Visits

CliniApps monitors visit the facility after completion of study for retrospective review of the following
  • Review and Completeness of the Screening Records
  • Review and Completeness of CRFs
  • Review and Completeness of TMF
  • Protocol Deviations and Impact Analysis
  • Appropriate Corrective Actions and Preventive Action
  • Ethics Committee and Sponsor Correspondence
  • Pharmacy Documents
  • IMP Accountability and Retention
  • Clinical Study Report (CSR)
  • Analytical Study Report
  • Individual Subject Chromatograms

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