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.
[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.
When approaching method comparison studies in CRO, prioritize statistical rigor while maintaining practical business relevance by establishing clear success metrics upfront, ensuring adequate sample sizes for meaningful results, and controlling external variables that could skew outcomes. Since statistical significance alone isn’t enough, researchers should focus on effect sizes and confidence intervals to understand how much and whether the difference between the two methods justifies any cost differentials of the methodologies. Most importantly, any quantitative results should be combined with qualitative insights to understand the “why” behind performance differences, which will help determine future optimization strategies beyond the immediate test results.
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.
