Clinical Studies and Regulations

We offer clinical research services in all aspects of study monitoring and site management from set up to closure including:

  1. Site evaluation and selection
  2. IRBs and CA submissions
  3. Informed consent forms development
  4. CRF design
  5. Study file set up
  6. Site trainings
  7. Site Contracts and budget negotiation
  8. Initiation visits
  9. Investigator meetings organization
  10. Translation and validation of study documents.
  11. Site management – documents
  12. Monitoring
  13. Safety reporting
  14. Site support – data base and query resolution
  15. Technical support
  16. Site closure.

All of our services are in accordance with the ICH-GCP, ISO and MOH guidelines for clinical trials in human beings.

We have an experience with safety studies, pivotal studies and post marketing studies.

For more information please contact Moran Feldman at [email protected],il