5 Myths about Academic Research Organizations
Myth 1. Academic Research Organizations are heavily focused on scientific innovation, but lacking in quality assurance measures.
Reality: Scientific innovation is certainly at the foundation of our organization. We are proud to specialize in the development and feasibility testing of novel imaging techniques and advanced assessments. However, partnering with the MGH Cardiovascular Imaging Core Lab (CVIC) does not mean compromising on quality assurance. We have a full library of Standard Operating Procedures (SOPs) that guide our organization, study management, and IT systems administration. In fact, quality assurance is emphasized throughout every step of our workflow. We encourage compliance groups to visit our facility to see for themselves. Our experience with sponsor audits has resulted in no critical findings to date, and we have successfully implemented corrective action plans to make important quality improvements. This ensures that our clients get the most out of their clinical trials. Our academic and industrial partners have all been extremely satisfied with our services.
|> CVIC provides services for a variety of trial types and sizes, engaging in both industry-funded and federal-funded clinical trials, as well as partnerships with other academic institutions for specialized services. Above is a display of our trial volume by type.
Myth 2. Academic Research Organizations can be unresponsive and don’t respect study timelines.
Reality: Every project at CVIC starts with a Project Management Plan where study timelines are presented and agreed upon. Then we make it happen. A smaller group means fewer hands on the data and less time waiting for the next department to do their job. The result is faster delivery of images to the reader and faster results to the sponsor. Don’t believe us? The MGH Cardiovascular Imaging Core Lab is becoming a member of the Metrics Champion Consortium (MCC) and will be participating in the Imaging Performance Metrics Initiative. So you can compare our performance directly to larger, industrial core labs and see just how efficiently we operate.
Myth 3. Employees at Academic Research Organizations are inexperienced and do not understand federal regulations and guidelines governing clinical research.
Reality: Our staff is made up of highly motivated and experienced industry professionals with comprehensive skill sets. All team members are trained in ICH-GCP and federal regulations. We also have first-hand knowledge of these guidelines through our involvement in clinical trials at MGH. We are exposed directly to the IRB review process and have developed a deep appreciation for HIPAA privacy rules. This experience enables us to recognize the challenges of patient recruitment and other logistical issues that sites face. With all this in mind, we understand what it takes to effectively manage an imaging trial. We have worked on multimodality imaging trials with up to 10,000 patients and coordinate with >200 clinical sites. Furthermore, because our investigators are engaged in leading-edge imaging studies, we have tremendous scientific knowledge that goes into every study and every dataset. Published literature even suggests that you may find more experience with an ARO than a traditional CRO.
>"We recently completed an imaging study in over 3,000 subjects with the Cardiovascular Imaging Core at MGH. Their team established an outstanding imaging protocol, collected all images, and conducted measurements using collaboratively developed read methodology that allowed us to investigate several important cardiovascular endpoints and quantitative fat measurements. Measurements were completed in a timely manner and according to specifications, and we were able to initiate research immediately after the completion of imaging. We are extremely pleased with the results and it would be my pleasure to work with them again"
- Scientific Director, Academic Partner
Myth 4. Academic Research Organizations are difficult to work with and do not communicate effectively.
Reality: During study start-up phase, CVIC works with our clients to establish a Communication Plan that includes regular teleconference and webinars. We also believe in the importance of transparency and direct communications as issues arise. Our Standard Reporting provides sponsors with the metrics needed to monitor and effectively manage study progress. Most importantly, our ability to connect with Clinical Sites is perhaps our greatest strength. We establish strong working relationships with staff at the Imaging Centers. This unique rapport with fellow radiology departments is made possible by our position within MGH Radiology and our close contact to world-class leaders in every area of imaging. Active communication with sites improves the quality of our data and adds tremendous value to the final analysis.
Myth 5. The contract process is painfully slow at Academic Research Organizations.
Reality: MGH Cardiovascular Imaging Core Lab works with Partners Clinical Research Office for all industry sponsored research trials. PCRO executed 2,219 agreements in fiscal year 2010. To achieve this volume, this group has streamlined the contract process. This means less back and forth with legal and a quicker start to study initiation.
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