CLINICAL TRIALS PROJECT MANAGEMENT SERVICES
- SOMO Enterprises provides services at every phase of the project from preclinical to Phase IV, we provide timely and accurate clinical trial data. This allows clients to make sound and cost-efficient decisions about safety, tolerability, efficacy, cost effective, and marketability for their services. With our high-energy team, we at SOMO Enterprises are committed to achieving the highest quality results, and seeing clinical trial projects to a successful end.
- SOMO Enterprises staff with their experience has the ability to handle large-scale clinical projects while providing the personal attention lacking in other larger contract research organizations. With fewer levels of management, our staff members are experienced and trained to be able to respond quickly to a client’s request and initiate action without having to consult committee or managers.
- Site Management: Solicitation/Feasibility, Qualification, Selection and Recruitment. This role involves full life cycle of monitoring – everything from Feasibility up to the Close Out stage including local submissions to EC/RA, site contracts/budgets. With experience on management of Oncology trials as beneficial.
- Regulatory Management: Ethics Committee and Regulatory applications
- Project Management and CTM Management
- Study Monitoring: Data Verification and Validation
- Medical Monitoring/SAE Reporting
- EDC Electronic Data Capture
- Risk Management
