RQM+ provides comprehensive clinical trial management services. We work collaboratively with sponsors and sites to anticipate challenges and proactively manage trials -- ensuring that results meet your expectations and are delivered on time. We also provide real-time data access to manage the enrollment and performance of your sites and surgical operators. Our clinical research associates and trial experts specialize in multiple data review and capture methods to deliver best-in-class data reconciliations. Our clinical operations teams are mapped to your clinical trial by expertise and years of experience -- providing the best on-site results for enrollment, strategic planning and communication.
Our services include:
Our Quality Management System (QMS) ensures that our services are compliant with all applicable regulatory quality standards, guidelines and laws, while also supporting the data integrity and safety of your trial. Additionally, our quality services team prepares you for any kind of inspection/audit. Proactive inspection preparation results in fewer findings and higher-quality data.
Our clinical safety team will drive the end-to-end safety management set up, coordination and reporting for your clinical trial. In coordination with our medical affairs team, we provide a seamless and on-time deliverable model to ensure all safety events and patient criteria are communicated, analyzed and reported.Our safety services include:
Our MedTech study start-up experts provide strategic oversight and leadership in all aspects of start-up and site activation for your clinical journey, inclusive of timelines and local and global regulatory requirements.Finally, we prepare the sites for initiation by:
Our transparent process gives you real-time data access during every clinical stage so that you can make well-informed decisions earlier in the trial. Our data management team ensures your data is reported, displayed, captured and fully compliant with global data and reporting requirements.Our services include:
Our biometrics team will recommend a customized program to design, collect, analyze, standardize and report your clinical trial data.Our biostatistcs services include:
Project management is essential in MedTech clinical trials to maintain and drive continuity and efficiency with our sponsors and internal stakeholders -- ensuring high-quality deliverables no matter the functional area of support. Project managers are responsible for delivering all aspects of the clinical trial on time and on budget while meeting quality expectations. Whether it is your early feasibility trial, 510(k), CE mark, premarket approval, post-market surveillance, decentralized trial or SaMD trial, we ensure efficient delivery of your project based on our:
RQM+ medical and scientific affairs physician experts leverage their experience with medical devices, combination products and diagnostics to provide the most suitable advisory and strategic methodology for your pre-market or commercial product and indication. We consider all applicable treatment guidelines, processes and impacts via the regulatory landscape to ensure safety and quality standards for your clinical trial.
Our clinical trials medical affairs support includes:
Our global team of seasoned medical writers has 40 years of expertise in all clinical specialties developing high-quality, concise documentation. Our writers collaborate with colleagues in regulatory and biostatistics, as well as project and data management, to ensure projects are efficient and seamless.
Our global team is comprised of engineers and scientists who understand how medical devices work, how performance is measured, and what type of documentation and evidence is required. With former regulators and notified bodies on staff, we have unique insights into how regulatory bodies and reviewers are likely to respond.
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