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CTMC is a Romanian CRO conducting clinical trails and offering the following services:
- Clinical Trials Phase II to IV and PMS
- Trial design and preparation
- CRF Design and ancillary documents
- Informed Consent design
- Investigators brochure
- Study set-up activities
- Feasibility studies (pre-study visits)
- Investigators and site selection
- Regulatory and ethics committee submissions (Preparation, translations, submissions, tracking of submission timelines)
- Management for Study Drug and Supplies
- Initiation visits
- Patient recruitment
- Project Management and Administration
- Clinical monitoring (Monitoring/co-monitoring visits)
- Study close out visits
- Post-Trial Follow-Up Monitoring (end of trial notification, transfer of documents to sponsor, submission of final report)
- Post-Trial document archiving and retrieval for audits
- Management of SAEs
- Quality control and audits
- Inspections
- Investigator meetings and medical communications
- Study team meetings
- Medical writing (Clinical study reports, Articles for publishing)
- Financial administration
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