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CCCP clinical services: preparation, regulatory approval, set up and conducting of your clinical study in various therapeutic areas. Depending on your needs, we offer:
Project management:
- preparation and tracking of project timelines and milestones
- selecting, training, managing and supervising the CRA team
- recruiting clinical sites and investigators
- investigator training and meetings
- establishing project communications and customized reporting systems
- adverse event reporting/safety plan development and maintenance
Clinical monitoring and site management:
- pre-study, initiation, interim and close-out monitoring visits
- site preparation and CRC training
- source documentation verification
- drug distribution and accountability
- SAE/AE reporting
Full logistical support: - set-up and conducting of investigators meetings
- investigators contracts and payments (including legal support)
- international vendors selection and management
- central lab assistance
- customs brokerage (import and export of clinical supplies, biological samples and equipment)
- IT support consulting
- printing and heavy-duty copying services
- medical communications: writing and translation of all study-related documents (majority of CCCP personnel are proficient in Russian and English, and hold advanced degrees in medicine and the life sciences).
Quality assurance: - site auditing
- QA consulting (regulatory package, study file, preparing to external audits)
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