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Study Management Services
Project Management
Preparation and oversight of medical device clinical trials is a vital, yet challenging task. Boston MedTech CRO offers project management tools tailored to the specific needs of each sponsor. Areas managed include:
- Negotiation with clinical sites – study implementation, budgeting, staffing, role of the site clinical coordinator, development of timelines for study milestones
- Patient recruitment and enrollment– identify channels to recruit patients, develop targeted media campaigns to support recruitment and expand referral networks of research patients needed to meet targeted enrollment.
- Reporting – provide weekly, monthly and ad-hoc progress reports to sponsors, including number of patients screened, enrolled and completed various phases of the study, logistical issues, technical problems, and any other pertinent issue impacting progress of study in accordance with study protocol and plans.
- Adverse event reporting – meeting reporting requirements of serious adverse events per GCP and local regulatory requirements