Cracking the IVDR Compliance Code for Clinical Trial Success
The In Vitro Diagnostic Regulation (IVDR) represents one of the most significant shifts in regulatory compliance for diagnostics in Europe. As clinical trials continue to become more global, pharmaceutical sponsors now face a new set of challenges that can directly impact study timelines, costs, and outcomes.
Understanding the Shift: From IVDD to IVDR
The IVDR replaces the previous In Vitro Diagnostic Directive (IVDD), tightening the requirements for In Vitro Diagnostic (IVD) medical devices.
The key impact under the new regulation is the increased responsibility placed on pharmaceutical sponsors. While previously the burden lay more heavily on IVD manufacturers, sponsors are now more directly responsible for ensuring that any diagnostic tools used for patient inclusion or management in clinical trials are IVDR compliant.
This shift means that sponsors must take an active role in demonstrating that the assays they use meet strict scientific, analytical, and clinical data standards. Sponsors are also tasked with ensuring that these tools comply with both European regulations and other regional standards if their trials span multiple geographies, such as CAP, CLIA, and U.S. FDA regulations.
A sponsor’s main goal is to ensure global IVDR compliance to protect potential future Investigational Medicinal Product (IMP) applications, with minimum impact on the clinical development strategy from a financial, time, and resource perspective. Achieving compliance requires sponsors to navigate a maze of regulatory requirements by using CE-marked assays, compliant Health Institutions, or conducting IVD clinical performance studies (CPS) alongside their trials. Given the significant financial and resource investment required for CPS, sponsors need to develop pragmatic strategies early in the protocol design phase to minimize risk.
LabConnect, with its specialized team from A4P Bio, is uniquely positioned to help sponsors with this level of responsibility required by the IVDR to ensure regulatory compliance while maintaining the integrity of their trial.
Overcoming IVDR Challenges with LabConnect’s Team of Experts
From understanding how current assays may fall under the new regulations to determining whether additional validation experiments are needed, sponsors are often overwhelmed by the complexity of compliance.
LabConnect helps sponsors overcome these hurdles by offering tailored solutions, including:
- Expert IVDR guidance during protocol design
- IVD market and documentation reviews, ensuring appropriate assay selection
- Comprehensive vendor assessments that ensure laboratories, manufacturers and CROs’ validation practices and regulatory compliance are robust enough to meet IVDR requirements
- Global alignment across multiple geographies to help sponsors manage cross-border regulatory requirements, ensuring compliance in every region where a clinical trial operates
- Expert support when working with laboratories to generate the necessary documentation and fill any gaps in available data
- Efficiently manage data with a transparent review process that allows for quick decision-making
LabConnect In Action: Navigating IVDR
In one case, a sponsor needed to include a biomarker for patient inclusion in an upcoming Phase II trial. The assay selected was not fully validated in line with the IVDR requirements. LabConnect assessed several laboratory options and performed a gap analysis, identifying additional analytical requirements to support the biomarker’s inclusion. The thorough review and actions taken ensured the sponsor could move forward with confidence, keeping the trial on track without unnecessary delays.
Your Trusted Partner for IVDR Compliance
Pharmaceutical sponsors turn to LabConnect for their unmatched expertise in diagnostic validation and regulatory compliance. With a broad network of laboratories and deep scientific knowledge, LabConnect offers the flexibility and global reach necessary to navigate the complexities of IVDR. LabConnect can work with any laboratory that best suits a sponsor’s needs, ensuring unbiased recommendations and the best possible outcomes. By leveraging LabConnect’s proven track record in diagnostic validation and regulatory strategy, sponsors can focus on what matters most – accelerating the development of new medicines around the world.