top of page
PROJECTS
Small medical device start-up company - Developing three medical devices in different clinical areas - set-up and management of the company clinical department, including preparation of Standard Operating Procedures (SOPs) and all clinical documents, requiring for clinical studies according to ICH-GCP guidelines, full performance of international clinical studies and clinical support throughout the whole device development process, including preparation of scientific summaries and final clinical reports for CE submission.
Medium size medical device company - Scientific review of all clinical studies, previously performed by the company in two clinical areas and preparation of Clinical Evaluation Reports (CERs) for periodic CE renewals.
Medium size medical device company - Internal Clinical Quality Audit (QCA) / Good Clinical Practice (GCP) Audit of the company clinical department, including the audit of the previously performed clinical studies, and presentation of the results for further fund raising.
Large medical device company with huge market access - Clinical review of hundreds of published literature reports and preparation of scientific summary for the company management and development of further marketing strategy.
Medium size US pharmaceutical company - Entire management of Phase II emergency clinical study in 5 centers in Israel, including regulatory submissions, negotiations on the study contract, project management, study monitoring and other clinical study responsibilities.
Huge international CRO - Entire responsibility of Phase III and IV clinical studies in Israel, including all tasks of local clinical studies, conducted by large pharmaceutical company.
Private statistical companies - Providing of medical writing services (study protocols, final clinical study reports).
bottom of page