Why IVD Specialization is a Game Changer for Sponsors
There are many factors a sponsor must consider when selecting the right contract research organization (CRO) for their next project. For instance, what range of CRO services do they provide, and do they have relevant experience that matches your project scope and needs? These two questions alone can highlight a CRO’s core strengths – as well as expose potential gaps. For diagnostic manufacturers, the answers are especially important as in vitro diagnostic (IVD) development demands an elevated level of specialization that many CROs are unable to offer.
As you consider your next partner, here are several ways a CRO specializing in IVDs can provide sponsors with a significant advantage in the successful development, validation, and regulatory approval of their diagnostic products:
- Organization-Wide Expertise: A company with diagnostics-focused CRO services will provide sponsors with relevant expertise across all functional levels of the organization. The immediate benefit for the sponsor is partnering with an integrated team that fully understands the complexities and intricacies of IVD development – and collectively brings knowledge and experience in managing and executing IVD-specific programs. They will know what detailed questions to ask and can provide pertinent insights and solutions right from the start. It is this deep familiarity that can set the foundation for a valued partnership and help sponsors realize the most effective and efficient path to market.
- Efficient Clinical Trial Management: In vitro diagnostic clinical studies are inherently unique when compared to other trials, such as the Research and Development inputs and coordination, and the analytical study requirements. These distinctions, and the implications of different IVD technologies, impact all aspects of clinical trial services including strategy, planning, budgeting, management, and execution. An experienced diagnostic CRO will have the processes, systems, and controls in place to allow for these specialized nuances to be properly addressed through all stages of clinical research — from study design, protocol development, and study start up to site monitoring, data collection, and study close-out.
- Targeted Regulatory Guidance: Global regulatory requirements for IVDs are continuously evolving and often diverging. CRO companies with extensive IVD experience are fluent in the complex regulatory requirements governing IVDs and are well-positioned to anticipate, identify, and respond to emerging challenges, smoothing the pathway to regulatory clearance or approval. A CRO providing end-to-end regulatory consulting and support can effectively facilitate and direct all phases of the process from initial regulatory strategy to post-market compliance activities.
- Robust Quality Assurance: Quality is essential to the success of any project. The right CRO partner will have tested and proven quality management systems in place to ensure the reliability, traceability, and accuracy of data generated from IVD assays. They can help evaluate, refine, and implement optimal quality management procedures as well as provide IVD-oriented gap assessments and remediation plans.
- Improved Patient Enrollment: CRO’s that can appropriately identify and access the right patient populations for an IVD clinical study are crucial for a successful outcome. The subject populations in IVD studies can vary greatly depending on the specific objectives of the study, intended use settings, the disease or condition being targeted and the impacts of the disease prevalence. A knowledgeable CRO can effectively support recruitment of eligible participants within the desired demographics, ensuring sufficient sample sizes and enrollment of required cohorts. Additionally, their expertise in study design optimization, study validity, regulatory compliance, and timely completion of the study contribute to overall efficiency in the research process.
- Analytical Study Insights: Sponsors will also benefit from a contract research organization with the knowledge and expertise in how to design and analyze analytical studies based on the Clinical and Laboratory Standards Institute (CLSI) guidelines (e.g., Reproducibility, Limit of Detection, Linearity, Reference Range, and Stability) required for a successful regulatory IVD submission. The CRO can leverage a deep understanding of regulatory agency requirements for IVD analytical studies and apply sound data collection and statistical principles to provide timely, accurate, and actionable analyses and reporting.
- Specialized Data Management: Clean, consistent, and validated data is central to every successful IVD regulatory submission. Advanced data management systems are often required to capture and handle the large volume of data generated including the handling of instrument data and the collection of multiple specimens from a subject. A CRO with clinical data management expertise specific to IVDs can maximize data quality and transparency, maintain data integrity and security, and quickly identify and correct issues. IVD-focused CROs are also well-versed in data privacy and security requirements and implement stringent measures to protect patient privacy and ensure data security during the study.
- Advanced Data Analysis: Sponsors will benefit from a CRO with the knowledge and expertise in bridging large-volume data collection and advanced biostatistical analysis to generate the meaningful insights and conclusions necessary for a successful regulatory IVD submission. This includes deep knowledge and understanding of the IVD clinical trial objectives/endpoints, study design, and expected analyses. The CRO can leverage a deep understanding of regulatory agency requirements for IVDs, and apply sound statistical principles to provide timely, accurate, and actionable analyses and reporting.
- Fast & Efficient Time to Market: By leveraging their specialized expertise, existing infrastructure, streamlined processes, and established relationships, CROs that are diagnostics centered can navigate the intricacies of IVD development and regulatory processes more effectively and efficiently. Their fluency with IVD-specific challenges allows for proactive identification and mitigation of potential issues, resulting in less errors and deviations, faster regulatory approvals, reduced time to market, and a competitive advantage for the IVD sponsor.
We recognize that selecting a contract research organization is not an easy process. Each CRO company will have its own guidelines for evaluation criteria for selecting a partner. In our experience, diagnostic sponsors quickly recognize the value of a CRO who fully understands the IVD landscape and has an established history of success in managing diagnostic clinical trials.
If you are looking for a CRO services partner that can best meet your needs, please contact us to learn about our full range of clinical, regulatory, and quality solutions and how you can benefit from the experience Beaufort provides our diagnostic clients.