CLINTREX has performed the following services:
- Provided services for > 150 companies, 5 foundations, and 10 CROs
- Assisted with the conduct of > 150 clinical trials
- Assisted in the conduct of > 15 pivotal trials
- Provided investigator training for > 50 clinical trials
- Established enrollment authorization committees for > 40 clinical trials
- Established, managed, or chaired DSMBs for >15 clinical trials.
- Established a course to train DSMB members
- Prepared for and attended in-person face to face meetings with FDA, EMA, and other regulatory agencies in support of > 25 sponsors (including pre-IND, EOP2, and pre-NDA meetings)
- Prepared white papers supporting orphan drug status, disease landscape, and other specific issues for multiple companies
- Created scientific and clinical communications to the financial and pharma/biotech communities on behalf of > 20 sponsors leading to successful IPOs, refinancing, acquisitions, and partnering.