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