The evaluation of risk and the focus on management of the key aspects that drive the outcomes and safety of each trial are integral to our success. We leverage our proprietary processes, along with best in class technology to deliver a superior clinical trial experience.
STORM™ or, Statistical Tools for the Optimization of Risk Management, is our unique application of the concept of starting and executing clinical trials with the end in mind. Cross- functional teams inclusive of clinical, regulatory and statistical experts begin evaluating the actual and potential risks associated with each unique trial during the earliest stage of our involvement.
RPG has provided clients with robust protocol assessments inclusive of considerations for risk management beginning at the proposal stage, well before the issuance of the FDA’s Guidance for Industry entitled, A Risk-based Approach to Monitoring (August, 2013). Once awarded the service contract, the cross-functional team further evaluates and determines, in close cooperation with the clients, the best and most efficient approaches to management of key risk from the standpoints of monitoring, data cleaning, safety management and ultimately, statistical evaluation of results. The results are more visibility for the clients and internal staff of site performance, data trends and subject safety over the trial, with the ultimate result being higher quality data to meet the objectives of the study.
RPG has implemented customized applications to aggregate site ratings based on data findings from central monitoring with subjective ratings based upon our interactions and knowledge of site characteristics (such as experience level of the PI and staff, turnover, responsiveness, etc.) in order to direct our dynamic approach to site management. Composite site ratings are reviewed routinely by the project management team for each study to direct the focus of our site interactions as well as the frequency and length of our on-site visits.
RPG always selects the best solution/tools/technology to match the unique requirements of each study. In addition to EDC, we use a wide range of tools for our projects, ePRO, IWRS and understand the strengths and weaknesses of systems, and will combine the needed tools in an efficient way to deliver project needs.
Senior management is closely involved in your trial. The Sponsor receives the attention of individuals who have not only worked with the largest CROs, but also those who have worked for large pharma. RPG understands the challenges of navigating the clinical trial process from both sides.
ResearchPoint Global has extensive experience with over 1400 clinical trials across all major therapeutic areas and product types (drugs, including small molecules and biologics, devices, and IVDs).
We are clinical development experts with knowledge and ability to execute across any therapeutic area, our most recent focus has been in Oncology, Endocrinology, CNS, and Cardiovascular. We also bring a unique understanding of and recent experience in Women’s Health and Pediatric studies.
We have site relations within each of the main areas and can ensure smooth startup of domestic and global studies in each area.
- Often we are quick to point out when things aren’t going right and rarely do we take the time to point out when our colleagues are doing a great job. I'd like to say that [Sr. Project Manager] and the RPG team are truly a pleasure to work with and go above and beyond helping us with this difficult study. You all are the face of the study and the relationships you have built with our sites speak to the 29 subjects enrolled in the USA. THANK YOU FOR ALL YOU DO!!!!!!Sponsor
- "The CRAs really became part of the team, offering opinions and suggestions along the way. The fact that the clinical sites had no observations noted during an FDA audit speaks to the CRA’s monitoring skills. We would not hesitate to work with ResearchPoint in the future."Associate DirectorClinical Operations (Pharma Company)
- "Thanks for a masterful job at running the investigators meeting this past weekend. It could not have been better and your leadership was evident throughout. It is obvious that we have chosen well in selecting you and ResearchPoint to assist us in this program."Executive Vice PresidentClinical Operations, (Pharma Company)
- "I just wanted to express all of our thanks once again for being such a great partner. Your continued support and guidance on the project is valued tremendously."Sponsor
- COOBiotechnology company
"RPG served as the single point of contact for a global study team comprised of RPG plus other CROs and multiple vendors. RPG's global PM was proactive in managing the 37 sites spread across 9 countries, successfully exceeding our time line by completing enrollment two months ahead of schedule."
- "We are small, and we will have several studies upcoming and I think the team here would really like RPGs personalized approach. My experience with your team was excellent, and that should be rewarded with additional potential business."Sponsor