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Whether you need a full-service CRO or just support for key study aspects, RQM+ can support your IVD clinical trials. At RQM+, we focus on partnership, collaboration, and quality at the highest level possible.
At RQM+, we believe there is no one-size fits all approach for IVD clinical trials. Each project is designed and executed to support our clients. We take a collaborative operational approach that is tailored to the intended use of the device, the envisioned markets, and the client's needs.
Our technical expertise and deep clinical trials backgrounds can support IVDs from any therapeutic area.
- Infectious disease including bacteriology, virology, parasitology
- Cancer detection, diagnosis, and monitoring
- Precision medicine
- Diabetes
- Genetics
- Microbiology
- Hematology
- Immunology
- Transfusion and transplant
- Women's Health
- Others
RQM+ will consider the specific requirements and claims of the device when supporting study design. Study design considerations for certain IVDs:
- Point-of-care (POC) tests / Near Patient tests (NPTs)
- Over the Counter (OTC) tests / Self Tests
- Companion Diagnostics (CDx)
- Reagents, controls, instruments, specimen collection · Novel biomarkers
- Interventional vs. observational studies
- Patient recruitment versus banked samples
- Molecular diagnostics including next generation sequencing (NGS)
- IVD software including artificial intelligence
- Instrumentation and associated software
- Immunoassays including ELISA
- Clinical chemistry
- Flow cytometry
- Microscopy
- Mass spectrometry
- Agglutination assays
- Lateral flow assays
- Novel technologies
Featured Leaders and Subject Matter Experts
Margot Borgel, Ph.D.
Director, IVD Global Regulatory Affairs
Margot Borgel, Ph.D. is the Director for IVD Intelligence and Innovation at RQM+ where she provides her expertise in IVDR implementation and notified body requirements. Prior to RQM+, Margot was a Technical Specialist at BSI, where she performed technical reviews for IVDR, IVDD and UKCA certification. She is especially passionate about certification of high-risk devices and enjoyed seeing these devices through IVDR certification while at BSI. Before her notified body work, Margot worked for Immucor, Inc. where she held roles in R&D, manufacturing technical support and manufacturing.
“The RQM+ IVD Team has the tools and expertise to provide IVD organizations a clear path to successful IVDR certification.”
Cari Kniola
Senior Director, Project Management
Cari Kniola is a clinical research professional with a strong foundation in project management and clinical trials. Her career journey, beginning with roles as a Clinical Research Associate (CRA) and Clinical Trial Manager (CTM), has led her to RQM+, where she plays a pivotal role in supporting IVD manufacturers. With her expertise centered on the strategic and operational aspects of clinical trials, Cari offers a focused and impactful approach to IVD clinical research, ensuring that projects are managed effectively and comply with the highest standards.
"At RQM+, my focus is on navigating the intricate landscape of IVD clinical research through effective project management and clinical trial expertise. Our aim is to elevate the standard of diagnostics, ensuring they are not just compliant but also significantly enhance patient care."
We are passionate about your success. Tell us more about your needs so we can help.
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