RSI – Research Management is the research operations arm of the Regenerative Sports Institute. Our primary goal is the improvement of patient outcomes and the advancement of medical science through innovation and quality execution of clinical research. Our perspective is not only based on statistical significance but also on clinical relevance.
RSI — Research Management provides clinical trial related services to contract research organizations (CRO), pharmaceutical companies, biotechnology companies, medical device companies, and clinical sites. Hospitals and health care institutions that do not have adequate infrastructure and staff to meet the requirements of clinical trial protocols of interest make up the majority of these clinical sites.
Our services include clinical monitoring, clinical project management, regulatory affairs and submissions, QA auditing, study start-up services, feasibility and site selection, data management, biostatistics, safety reporting, and medical monitoring. It is our role to be a trusted advisor, making decisions and acting with our clients’ best interests in mind.
Our main service offerings at RSI include:
- Contract negotiations
- Submission for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval
- Patient education
- Patient recruitment
- Patient follow-up
- Drafting appropriate Informed consent forms (ICF)
- Site initiation and trial close-out operations
- Trial-related documents archival and maintenance
- Reporting serious adverse events to the Sponsor or CRO and the IRB
- Ensuring protocol compliance
- Advising & alerting investigators of potential protocol violations
- Data management
Dr. Gregory E. Lutz matriculated to Georgetown University School of Medicine in 1984, having graduated from Drew University magna cum laude and Phi Beta Kappa. He graduated from medical school in 1988 and was awarded the Margaret M. Kenrick Achievement Award in Physical Medicine & Rehabilitation. He pursued his specialty training in Physical Medicine & Rehabilitation at the Mayo Clinic in Rochester, MN. Following his residency, he completed an Orthopedic Sports Medicine Fellowship at the Hospital for Special Surgery (HSS) in New York City. Dr. Lutz has been in practice at the Hospital for Special Surgery since 1993.
Dr. Lutz is currently the Physiatrist-in-Chief Emeritus for the Hospital for Special Surgery and is a former member of their board of trustees. He is an Associate Professor of Clinical Rehabilitation Medicine at Weill Medical College of Cornell, and Founder of the Regenerative SportsCare Institute (RSI) in Manhattan. He is also a consulting physician to the National Hockey League’s Players Association.
Kwadwo Boachie-Adjei previously served as the Research & Administrative Coordinator at the Hospital for Special Surgery with the Department of Physiatry. He is an Epidemiologist and consultant in the Life Science disciplines in the greater New York City area.
Mr. Boachie-Adjei completed his graduate program with a focus on Epidemiology and International Health from The Harvard School of Public Health and also holds a Bachelor of Science degree in Biology from Syracuse University where he also minored in Economics.
Kwadwo Boachie-Adjei sits on the Board of Directors for the Foundation of Orthopedics and Complex Spine (FOCOS). FOCOS is a non-profit organization based in the U.S with operations in Ghana. FOCOS aims to improve the quality of life of patients in need throughout Africa and other parts of the world by providing optimum orthopedic care.
Our Core Values & Philosophy
Our primary core values are to place the needs of the client above all else. Our philosophy is to assist and enable the client to offer the best treatment options based on sound evidence-based research. We are results-oriented and set high standards for our clients as well as ourselves.
RSI-RM will design and implement a data management system using optimized Clinical Trial Management Solutions (CTMS) for trials that is fully compliant with industry guidelines and FDA requirements. Our multifaceted platform enables us to support both paper and electronic data capture (EDC) to meet the unique requirements of the client and their study participants.
From database creation to database implementation, our data management team serves as an extension of your own team. Our solutions are easily customized to meet your specific trial needs and budget constraints.
Our innovative, performance-driven approach and resources can ensure that your studies yield high quality data within strict timelines and budget requirements.
Regulatory Filings & Medical Monitoring
As a core service offering at RSI-RM, our division of Regulatory and Medical Affairs provides our clients with expertise in working with agencies such as the FDA. Our regulatory personnel are dedicated to sharing their knowledge of the complex regulatory environment needed from Phase I through Phase IV trials. Our experienced staff is committed to the ever-changing regulatory climate through continuous education, trend analysis, and the awareness of industry standards. Utilizing an optimized CTMS platform to manage workflow allows our team to streamline our regulatory knowledge.
From Regulatory Support, Safety Oversight and Pharmacovigilance, and therapeutic expertise, our global network of experts provide a range of strategic services to support clinical trials in all stages of development. Providing regulatory consultation and ongoing assessment throughout the product lifecycle, and ensuring your data is submission-ready, is our key niche.
Medical Writing/Statistical Analysis & Reporting
At RSI-RM, our statisticians are well versed in industry and academic clinical research methodologies and have vast experience in the statistical design and analysis of clinical and non-clinical studies. They specialize in SAS™, STATA™, and SPSS™ programming for summary, analysis, and presentation of study data.
Our clients receiving critical data on time is always one of our key priorities and considered to be of utmost importance. Our expertise allows for collaboration that will result in better, and faster, product and device decision-making processes for you and your patients.
Our team provides guidance on the statistical components throughout all stages of your studies and assures that strata, cohorts, and demographics are handled appropriately, along with efficient use of hypothesis tests, modeling, graphing, etc. for analysis of the data. We use the most up to date software including, SAS™, STATA™, and SPSS™ to manage data collection and statistical analysis.