Boston MedTech CRO (Contract Research Organization) Group is associated with Boston MedTech Advisors, a consulting and professional services company focusing on establishing and accelerating market adoption of new medical technologies. We support our clients in the commercialization of new products and services by addressing the highly inter-dependent regulatory, clinical development, reimbursement, marketing and business development requirements of the global medical technology industry.
Boston MedTech CRO provides medical device companies and other clinical trial sponsors the necessary resources to design and implement all phases of clinical trials design and management, whether intended to support regulatory filings, marketing, reimbursement or R&D.
Boston MedTech CRO is a full-service provider, offering a suite of services, carefully customized to meet the unique requirements of the business or entity sponsoring the clinical study.
- Study Design
- Site and Principal Investigator Selection
- Site Liaison
- IRB Applications
- Enrollment Planning
- Project Management
- Adverse Event Reporting
- Data Safety Monitoring Board
- Clinical Trial Monitoring
- Data Management
- Statistical Design and Analysis
- IRB reporting requirements
- Report Preparation
- Operational and Logistical Support
Boston MedTech CRO specializes in the complete management of U.S. and International clinical trials (e.g. European, Asian) for medical technologies, including devices and combination products. Our experienced team of regulatory experts, clinical research associates (CRA), physicians and statisticians is knowledgeable in FDA, CE, GCP and ICH standards and regulations, data integrity and patient safety reporting requirements.