The accreditation strengthens Avania’s ability to support medical device, diagnostic, and combination product clinical trials using one of the industry-leading electronic data capture platform
The accreditation strengthens Avania’s ability to support medical device, diagnostic, and combination product clinical trials using one of the industry-leading electronic data capture platform
Marlborough, MA & Bilthoven, Netherlands, July 6, 2026 — Avania, a global MedTech-focused CRO purpose-built to navigate the distinct clinical, regulatory, and evidence-generation needs of medical devices, diagnostics, and combination products, today announced it has achieved Accredited Partner status with Medidata for Rave EDC.
The accreditation expands Avania’s clinical data management capabilities, enabling the company to support sponsors across a broader range of MedTech clinical programs that require robust, scalable data capture infrastructure aligned with the operational realities of medical device, diagnostic, and combination product trials.
According to the ISR Market Research 2025 EDC Benchmarking Report, Medidata Rave EDC is an industry-leading electronic data capture platform, with 83% of respondents identifying it as a category leader.
What Makes Avania a Leading MedTech CRO for Clinical Data Management
Avania’s Clinical Development team has supported more than 1,250 clinical trials across medical devices, diagnostics, and combination products, spanning early feasibility, first-in-human, pivotal, and post-market studies. Avania’s Clinical Development model integrates project management, clinical operations, field clinical specialists, data management, biostatistics, medical writing, safety management, and imaging core lab services within a single delivery model.
Adding Rave EDC to the data management portfolio strengthens this integrated approach, giving sponsors access to a platform that aligns with fit-for-purpose MedTech study designs, procedural workflows, device-specific endpoints, and evidence requirements.
Why MedTech Clinical Trials Require a Fit-for-Purpose Data Management Approach
Medical device, diagnostic, and combination product trials often differ from traditional drug development programs in how evidence is generated, captured, and reviewed. Data management strategies must be fit for purpose and account for the study design, device use, procedural workflows, operator technique, device effectiveness and performance endpoints, imaging or core lab inputs, safety reporting model, and regulatory pathway, while also accommodating a wide range of site environments and device-specific data capture requirements.
Evidence must reflect not only clinical outcomes, but also how the device is used, procedural context, usability, operator variability, device effectiveness, and device performance, while meeting applicable regulatory expectations.
Rave EDC fits within Avania’s clinical infrastructure by enabling advanced data management capabilities, including real-time edit checks, dynamic field logic, and configurable workflows that align with fit-for-purpose medical device, diagnostic, and combination product study requirements. By addressing data issues at the point of entry and delivering immediate site feedback, teams can identify and resolve data questions earlier in the study lifecycle rather than relying primarily on downstream review.
For sponsors, this translates into improved data quality, fewer repetitive queries, reduced review timelines, and a shorter path from last patient out to database lock.
“Rave EDC adds another industry-leading option to Avania’s data management portfolio and strengthens our ability to take a fit-for-purpose approach to each study. The value is not a one-system model; it is being able to match the EDC environment to the sponsor’s protocol, data volume, endpoint strategy, and operational needs. For studies that benefit from Rave’s scale and configurability, we now have accredited capability in-house, while continuing to use other validated systems when they are the better fit. That flexibility helps sponsors capture high-quality data, reduce avoidable queries, and move efficiently toward database lock,” said Charlene Dark, Chief Operating Officer, Avania.
What Avania’s Accredited Partner Status Means for Sponsors
Avania’s data management team has completed the full Medidata accreditation process, covering Rave EDC functionality, database build best practices, and operational implementation.
For MedTech sponsors, data management often requires close alignment among clinical outcomes, adverse events, device deficiencies, procedure details, imaging, endpoint assessments, and, where applicable, complaint or product-performance information. Depending on the study design and sponsor infrastructure, safety information may be managed through an integrated safety system, within the EDC environment, or through a hybrid approach. Avania’s team is equipped to support these models in a way that aligns with sponsor needs, regulatory expectations, and study operations.
“By combining Avania’s medical device expertise with Medidata’s leading data capture platform, we are positioned to deliver something sponsors don’t often find in one place: deep MedTech clinical knowledge and advanced technology to support more efficient, high-quality trials from study build through database lock,” said Richard Veerman, Director of Data Management, Avania.
About Avania
Avania is a global MedTech-focused CRO, purpose-built to navigate the distinct clinical, regulatory, and market access requirements of medical devices, diagnostics, and combination products. Integrating regulatory strategy, clinical development, and market access and reimbursement, Avania takes innovations from concept to commercialization with confidence. With 1,250+ clinical trials executed and 450+ regulatory and market access filings, Avania supports the world’s leading MedTech companies as well as emerging innovators.
MedTech’s Trusted Champion. Learn more at avaniaclinical.com.