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RQMIS
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Clinical Trial Management

RQMIS collaborates with clinicians and clients to design and manage clinical studies that deliver reliable, actionable results..

Bringing a medical device to market requires robust clinical evidence that meets the stringent regulatory requirements of the FDA, EU MDR, and other global regulatory bodies. At RQMIS, we provide end-to-end clinical trial management services to help you efficiently generate the data needed for approval while ensuring compliance with Good Clinical Practice (GCP) and international standards.

Our expert team guides you through every stage of the clinical trial process, from planning and site selection to execution, monitoring, and final reporting. Whether you need full-service trial management or targeted support for specific trial components, RQMIS delivers customized solutions to meet your unique needs.

Our Clinical Trial Management Capabilities

1. Clinical Trial Design & Strategy

  • Development of clinical study protocols aligned with regulatory requirements
  • Identification of the most efficient trial design to support regulatory submissions
  • Risk-based approach to trial planning for optimal resource utilization
  • Regulatory strategy consulting to ensure study compliance and efficiency

2. Site Selection & Investigator Coordination

  • Identification and qualification of clinical trial sites and investigators
  • Assistance with site feasibility assessments and regulatory approvals
  • Development of investigator training materials and study documentation

3. Regulatory & Ethics Committee Submissions

  • Preparation and submission of Investigational Device Exemptions (IDE) to the FDA
  • Coordination of Ethics Committee (EC) and Institutional Review Board (IRB) submissions
  • Support for Notified Body and Competent Authority interactions in the EU

4. Clinical Trial Monitoring & Compliance

  • On-site and remote monitoring to ensure protocol adherence and data integrity
  • Implementation of risk-based monitoring (RBM) for enhanced efficiency
  • Compliance audits to ensure adherence to GCP, ISO 14155, and other relevant standards

5. Data Management & Biostatistics

  • Development of electronic data capture (EDC) systems for streamlined data collection
  • Statistical analysis to support regulatory filings and clinical study reports (CSRs)
  • Management of data queries and quality control measures

6. Clinical Study Reporting & Submission Support

  • Preparation of Clinical Study Reports (CSRs) and regulatory submissions
  • Compilation of Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) plans
  • Submission of trial results to regulatory authorities and medical journals

Why Choose RQMIS for Clinical Trial Management?

  • Regulatory Expertise: Our team has in-depth knowledge of FDA, EU MDR, and global regulatory requirements.
  • Customized Solutions: We tailor our clinical trial strategies to your specific product and market goals.
  • Efficient Execution: Our streamlined processes help reduce trial timelines and costs.
  • Compliance Assurance: We ensure your study meets all GCP, ISO, and regulatory guidelines.

Whether you’re conducting an early feasibility study, pivotal trial, or post-market clinical follow-up, RQMIS provides the expertise and support needed to navigate the complexities of clinical research.

Let’s discuss how we can optimize your clinical trial strategy.