Beaufort provides expert guidance throughout your in-vitro diagnostics (IVD) development journey, delivering specialized clinical trials designed specifically for diagnostic innovations with regulatory success in mind.
Our specialized experience spans the complete IVD spectrum, with deep expertise in both established and emerging diagnostic technologies across all major therapeutic areas and regulatory pathways.
As an IVD CRO, our technical expertise covers the complete spectrum of diagnostic platforms, from traditional methods to cutting-edge solutions. We understand the unique validation challenges and regulatory considerations for each technology type, ensuring optimized study designs.
Our extensive IVD experience spans all major therapeutic domains, with particular depth in infectious disease, oncology, and cardiovascular diagnostics. We understand the unique specimen requirements, reference standards, and clinical endpoints essential for each area.
From high-complexity labs to point-of-care environments, we tailor validation strategies to your intended use setting. Our experience in CLIA waiver studies, professional use, and direct-to-consumer applications ensures appropriate usability assessments and regulatory approach.
We navigate the evolving global IVD regulatory landscape with confidence, guiding clients through FDA 510(k), De Novo, and PMA pathways, EU IVDR compliance, and international market access strategies. Our approach aligns clinical evidence with specific regulatory requirements. Beaufort’s regulatory team develops and manages Pre-Submission (Q-Sub) strategies that open direct lines of communication with the FDA.
Beaufort’s proprietary sample management platform ensures the accuracy, reliability, and integrity of data across the full sample lifecycle in IVD clinical trials. By entering, reviewing, and trending data on sample processing and handling, labeling, storage, and transportation, Beaufort prevents sample loss, degradation, and misidentification that could compromise study results.
Beaufort designs and manages the full range of IVD studies required for regulatory clearance and approval, as well as market access. Our teams bring hands-on experience across every major study type, so your program moves forward without gaps.
Performance studies:
Analytical Studies:
[We] went through a significant search process when selecting our CRO. We chose Beaufort, and I must say it has been a great decision. The company is extremely competent, with a strong specialization in IVD/Diagnostic trials. They are really great to work with, and their expertise and advice in the IVD trial world have been right on target. Someday, when I look back at the things we did right, engaging Beaufort will be one of the key ones.
Stay current with expert perspectives on IVD innovation, regulatory developments, and clinical trial optimization from our diagnostic industry specialists.
View All InsightsGet answers to some of the most common questions about IVD
clinical trials and CRO services.
IVD clinical trials and drug trials differ in their objectives. While drug trials focus on establishing therapeutic efficacy and safety, diagnostic trials aim to prove diagnostic accuracy and analytical performance. These primary endpoints for diagnostics center on sensitivity, specificity, and predictive values compared to established reference standards, rather than clinical outcomes like mortality or symptom improvement. This fundamental difference enables IVD companies to leverage streamlined regulatory pathways like 510(k) clearance, significantly reducing development timelines and costs.
Compliance with the EU’s In Vitro Diagnostic Medical Device Regulation (IVDR) requires medical device companies to properly classify their diagnostic products and work with notified bodies for conformity assessments. Manufacturers must establish quality management systems, gather clinical evidence to prove their devices work safely and effectively, and maintain detailed technical documentation. Non-EU companies need an authorized representative based in Europe to handle regulatory responsibilities. Additionally, companies must continuously monitor their products after they reach the market to ensure ongoing safety and performance.
Specialized IVD CROs bring deep regulatory expertise and proven clinical experience in diagnostic studies to support sponsors. They offer access to specialized facilities, cutting-edge equipment, and seasoned professionals without the substantial investment required to build these capabilities in-house. By leveraging their established processes and regulatory relationships, companies can significantly reduce the risk of delays as well as overall development costs. This allows IVD companies to focus on their core competencies while ensuring their diagnostic products meet stringent quality and regulatory standards efficiently.
Method Comparison studies require careful design from the outset to ensure the data generated is statistically valid, regulatory-ready, and fit for its intended purpose.
Beaufort designs Method Comparison studies in accordance with established CLSI guidance — EP09 for assays with quantitative output and EP12 for assays with qualitative output. Regardless of the assay type, every well-designed Method Comparison study addresses three core considerations:
Quantitative assays (EP09): For studies involving quantitative output — such as a hepatology or gastroenterology biomarker — it is essential to assess whether differences between measurement procedures are proportional or constant across the measurement range, and to ensure samples adequately span low, medium, and high values. Randomization of replicates is critical where multiple samples are drawn from the same subject.
Qualitative assays (EP12): For studies involving qualitative output — such as infectious disease or STI diagnostics — key design decisions include selection of the reference standard, specimen collection and randomization procedures, and blinding of results to prevent bias in endpoint determination.
Beaufort brings hands-on experience designing and executing both study types across multiple therapeutic areas, regulatory pathways, and submission types.
Companion diagnostic development requires coordinating with pharmaceutical companies to get both the diagnostic test and drug approved together, which creates complex regulatory and timing challenges. Developing accurate tests that identify the most appropriate patients for specific treatments requires extensive clinical validation and significant investment. Companies must carefully align their development schedules with drug partners while proving the test’s value.
Most moderate-risk (Class II) IVDs require FDA clearance through the 510(k) pathway before they can be marketed in the United States. Through a 510(k), manufacturers demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Low- to moderate-risk IVDs without a suitable predicate may instead be eligible for De Novo classification, while higher-risk devices generally require Premarket Approval (PMA).
Whether clinical data are required depends on the device, the predicate, and the nature of any differences between them. Clinical data are not required for every 510(k). FDA may expect clinical performance data when analytical and non-clinical testing alone cannot adequately establish substantial equivalence.
Common situations where clinical data may be needed include:
| Scenario | Example |
|---|---|
| Differences in intended use between the new IVD and the predicate | Expanding testing to a new patient population or adding a new clinical indication |
| Differences in technological characteristics that raise questions about safety and effectiveness | A novel detection technology or a new specimen type |
| Analytical and non-clinical testing alone cannot establish substantial equivalence | No recognized reference standard or validated comparator method exists for the biomarker being measured |
| Newly identified or increased risk associated with the predicate raises questions about the new device | Additional clinical evidence is needed to address risks newly identified for the predicate device |
Determining early whether clinical data are likely to be required can significantly affect development timelines, study design, regulatory strategy, and submission readiness.
The duration of an IVD clinical trial varies significantly depending on the study type, regulatory pathway, enrollment complexity, and specimen requirements. Every study moves through the same fundamental phases and timeline management at each stage determines overall success.
Study Start-Up: Typically 1 to 3 months. Covers protocol finalization, site identification and qualification, contract and budget negotiation, IRB/EC submission and approval, site initiation, and EDC and laboratory set-up. Start-up is where most study delays originate and where early operational discipline has the greatest impact on overall timeline.
Enrollment: Timelines vary by study type:
Close-Out: Typically months. Covers database lock, statistical analysis, site close-outs, CSR preparation, and TMF delivery.
At Beaufort, our experience across IVD study types, combined with proactive site management, risk-based monitoring, and centralized enrollment oversight, is designed to keep studies on timeline and address risks before they become delays.
