Gaps in data handling or reporting structure can delay assessment and trigger additional information requests. For you as a sponsor, this service ensures that data generated during your investigation can be used with confidence for regulatory and internal decision-making.

How Apices delivers data management and reporting

Apices supports data management and reporting for medical device studies through structured, in-house processes aligned with regulatory expectations. Data collection and management activities are planned early, alongside clinical investigation design, so that data flows reflect how sites will actually operate.

Data validation, review, and reporting are managed in close coordination with clinical operations and monitoring. This ensures that issues are identified early and that reported outputs accurately reflect study conduct.

Because data management and reporting are delivered within the same operational framework as the rest of the study, you benefit from continuity and clear ownership throughout the investigation.

Alignment with regulatory and operational requirements

Data management and reporting at Apices are aligned with notified body expectations and applicable device regulations. Reporting structures are designed to support clinical evaluation and regulatory assessment without unnecessary reformatting or rework.

Close collaboration with medical writing ensures that data outputs are presented clearly and consistently across reports and submission documents.

Regulatory framework considered

Data management and reporting activities are performed in alignment with applicable medical device regulatory requirements. In the European Union, this includes Regulation (EU) 2017/745 on medical devices (MDR), relevant MDCG guidance, ISO 14155 for good clinical practice in medical device clinical investigations, and expectations for clinical investigation reporting and clinical evaluation. Where applicable, U.S. regulatory requirements are considered, including FDA regulations under 21 CFR Parts 812 (Investigational Device Exemptions), 11 (electronic records and signatures), and applicable data integrity and reporting guidance, to support global submission strategies.

What you can expect from this service

You can expect structured datasets and clear clinical investigation reports that support regulatory review. Data are handled in a controlled manner, with traceability and consistency across the study lifecycle.

Data management and reporting at Apices are designed for medical device sponsors who want predictable regulatory interactions and defensible clinical evidence.