MedicSense Ltd. is a Clinical Research Organization (CRO) that specializes in planning, management and monitoring of pre-clinical and clinical trials for medical devices. Our experienced team of scientists, statisticians, engineers and CRAs will assure that the study meets regulatory expectation and complies with ICH-GCP Guidelines. Our services include:

  • Development of clinical research strategies.
  • Allocation of investigational sites and investigators including opinion leaders.
  • Development and preparation of study protocols for pre-clinical and clinical trials.
  • Statistical planning.
  • Development and preparation of Case Report Form (CRF).
  • Preparation of clinical affairs Standard Operating Procedures (SOPs).
  • Definition of Informed Consent (IC) form in accordance with local regulations.
  • Submission to and liaison with Ethic Committees/IRB and MOHs.
  • Preparation of Investigator Brochure (IB).
  • Preparation of Investigator Files (IF).
  • Conducting of site monitoring visits in accordance to ICH-GCP guidelines including preparation visit reports.
  • Data management and analysis.
  • Preparation of statistical reports and overall study reports.