Harris Orthopaedics Laboratory: Clinical Studies and Post-Market Surveillance

As a full-service Academic Contract Research Organization (ACRO), the Harris Orthopaedics Laboratory provides comprehensive clinical research services, drawing upon the clinical trial expertise of its Harvard Medical School affiliated academic faculty and Massachusetts General Hospital affiliated professional staff.

Harris Orthopaedics Laboratory is a full-service Academic Contract Research Organization (ACRO), that draws upon the clinical trial expertise of its Harvard Medical School affiliated academic faculty and Massachusetts General Hospital affiliated professional staff to provide comprehensive clinical research and pre- and post-market surveillance services.

Harris Orthopaedics Laboratory is associated with a number of Joint Registries in the US, Australia, UK and the Nordic countries. This enables us to limit duplicate data entry, offer improved study site management and communication, and follow patient outcomes long-term via the registries. We also collaborate with AdvaMed and Eucomed to develop global guidelines for post-market surveillance and reporting. Nested studies, which are studies organized within countries or regions with well-established joint registries, can provide the detailed clinical outcome results needed for early benchmarking of new technologies. They can also provide the basis for registry-based post-market surveillance needed for longer-term reporting. The strong academic focus of the ACRO offers opportunities for peer-reviewed scientific publications, and it can generate and provide the detailed results needed for reporting to notified bodies around the world.

Services:

• Study Design
• Project Management
• Site Management and Monitoring
  • Assistance with Worldwide Site Selection and Subcontracting
  • US, Australia, South Africa, UK, Europe
  • Site Payments
  • Recruitment and Follow-up, Optimization
• Data Management using CFR 21 Part 11 Compliant Data Collection and Reporting System
  • Patient Reported Outcome Measures (PROMS)
  • Radiographic Analysis
  • Soft Tissue Imaging Analysis
• Statistical Analysis
• Adverse Event Monitoring and Reporting
• Scientific Manuscript Development and Presentations at International Conferences
• Data and Safety Monitoring Board (DSMB) Set-up and Coordination
• Post-Market Surveillance
• FDA post-approval studies
• FDA 522 studies
• Data collection and reporting for CE mark maintenance according to the Medical Device Directive (MDD) and guidelines MEDEV 2.7.1 Rev 3
• ODEP reporting for United Kingdom
• Reporting to other notified bodies

Academic Program

The ACRO helps sponsor MD/PhD students with an interest in registry science in a visiting Fellowship program designed to develop the students skills in clinical outcomes research and the analysis of large data sets obtained through collaboration with national and regional arthroplasty registries. The fellowships range from six months to one year. During their time in Boston, the students take advantage of the training courses offered by Mass General and Harvard University, such as those related to ethics, statistical analysis, proper conduct of human research and leadership development. Educational opportunities include: travel to national and international conferences such as the American Academy of Orthopedic Surgeons and the International Society of Arthroplasty Registries; interaction with leaders in the field of arthroplasty registries; visits to national registry sites and interaction with various registry leaders; participation in data mining and data analysis; abstract and manuscript preparation.

This program is well suited for clinician scientists interested in making the conduct of clinical outcomes studies and registry interaction a part of their career and for those who reside in countries with established or developing national and regional registries. Past participants: Denmark: Karl Tobias Haak MD, PhD; Henrik Palm MD, PhD; Anders Troelsen MD, PhD, Kirill Gromov MD, PhD; Nanna H. Sillesen MD, PhD; Christian Skovgaard Nielsen MD, PhD · Sweden: Ola Rolfson MD, PhD; Viktor Lindgren MD, PhD · Finland: Rami Madanat MD, PhD.