Clinical trial services

RQM+ provides comprehensive clinical trial management services. To ensure that results meet your expectations and are delivered on time, we work collaboratively with sponsors and sites to anticipate challenges and proactively manage trials.

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:

• Patient and site recruitment and scenario planning
• Patient and site retention and engagement
• Risk-based monitoring strategies
  
  • Decentralized patient retention and engagement
• Conducting site visits
  • Pre-study qualifications
  • Site initiation visits
  • Interim monitoring visits
  • Close-out visits
• Clinical operations management and communication

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.  

We offer:

• Full-study file reviews
• Sponsor-directed audits
• Bioresearch Monitoring (BIMO) preparatory audits
• Supplier qualification auditing

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.  

• Draft and implementation of the safety management plan (SMP) and process for your clinical trial
• Case processing of all product safety events per protocol
• Narrative prep and finalization for adverse events (AEs) and serious adverse events (SAEs)
• Case and event reporting protocol
• Facilitating meetings and coordination with Clinical Endpoint Committees (CECs) and Data Safety Monitoring Boards (DSMBs) as required
• Reporting of unanticipated device effects (UADEs) and other required events, such as device malfunctions and device failures, which meet the criteria to be reported and mitigated during the trial phase

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.

• Site and feasibility analysis
• Site activation and approvals per study and portfolio
• Site contracts and budgets
• Site and project communication
• Timeline management
• Risk mitigation strategies during start-up phase

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.

• Case report form (CRF) development
• Database build
• Data review and cleaning
• Data visualization and reporting
• Data standardization 
• Data integration: Application Programming Interface (API)
• Data lock
• Data entry

Our biometrics team will recommend a customized program to design, collect, analyze, standardize and report your clinical trial data.

• Statistical consulting
• Study design
• Randomization
• Statistical analysis
• Programming and data analysis

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 study (EFS), 510(k), CE mark, premarket approval, post-market surveillance, decentralized trial or SaMD trial, we ensure efficient delivery of your project based on our:

• Therapeutically matched experience
• Regional or multi-national experience
• Background in managing multi-functional and dynamic projects and programs
• Resource planning and methodologies
• Technical and clinical development operating models
• Knowledge of current local and global regulations within the MedTech industry
• Risk mitigation strategies
• Maintenance and promotion of high-performing teams and solutions
• Budget and finance models for effective delivery of contracted relationships
• Excellent transparency and communication

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:

• Trial design and advisory support
• Medical monitoring support
• Development and execution of the medical monitoring plan
• Safety event/case medical input
• Endpoint adjudication and data safety monitoring board advisory and management support
  • Committee member selection and qualification
  • Contract and agreement support
• Medical affairs and scientific strategy on a per-product and therapeutic basis
• Building and maintaining relationships with key opinion leaders (healthcare practitioners, academic researchers, sponsor advocates and experts in defined therapeutic areas)
• Sponsoring education programs for healthcare practitioners, sponsors and clinical trial stakeholders
• Supporting internal and external training programs
• Gathering and sharing market intelligence with internal and external stakeholders

At RQM+, our medical writing team is an integral partner from the very beginning of your project, collaborating closely with you to define trial specifics, align with regulatory frameworks, and design studies and outcome measures that meet your unique goals.

Our medically and scientifically trained experts craft study protocols for your medical device trial that tie together State-of-the-Art, patient characteristics, treatment strategies, and the intended use of your medical device.

We deliver high-quality interim and final reports, and we prepare manuscripts that adhere to academic standards, ensuring seamless publication of your study protocols or results.

Whether your project involves randomized controlled trials (RCTs), registries, chart reviews, or post-market clinical follow-up (PMCF) studies, our medical writing team is equipped to provide the precision and expertise you need to succeed.

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.