Clinical Diagnostics

We are a global leader specializing in all phases of diagnostic research from discovery, development and validation,and commercialization with experts on staff to conduct research in the Americas, Europe and the Asia Pacific region. Our diverse experience in this area provides our clients a level of comfort because we understand that these are not drug development studies. We understand the importance of clinical in-vitro diagnostic and biomarker research for the greater good of healthcare. Our central monitoring approach and comprehensive knowledge of the regulatory environments help to speed up study timelines, focus on patient outcomes and optimize your clinical sample quality.

We understand these are not Drug Development studies and work with sponsors to run these studies in a way that will optimize your global sample quality.

Kathleen Mandziuk – Senior Scientific Affairs Director, Clinical Diagnostic Services

Clinical In-Vitro Diagnostic (IVD) & Biomarker Research

PRA’s Clinical Diagnostic Services (CDS) division specializes in a range of services extending to cover the complex activities of clinical in-vitro diagnostic (IVD) and biomarker research. We have proven experience and understand the importance of identification of high-volume real-world sites, robust sample integrity and rapid seamless sample processing. We are a global leader in the clinical diagnostic space with experts on staff to conduct clinical in-vitro diagnostic (IVD) research in US, EU and Asia Pacific regions. Our proactive and multilingual project teams have successfully managed large (>100,000 samples) and small through our local knowledge of cultures and beliefs, as well as how to deal with real world physicians around the world. Our comprehensive knowledge of global clinical IVD regulatory environments helps to support high sample quality, and is evident in how we are able and effectively speed up study timelines. Using our minimal risk research expertise, we are able to build a cost effective and streamlined global operational approach for diagnostics studies. A few highlights of our clinical IVD development experience and expertise:
  • Specialize in real-world clinical IVD research
    • Expertise across all phases of diagnostic research: discovery, development and validation, and commercialization
    • Successfully manage diagnostic studies small and large –knowing their importance for the greater good of healthcare
    • Comprehensive knowledge of predicate comparison validation, clinical utility/point of care and patient outcome studies
  • Global expertise
    • Cost effective and streamlined global operational approach for both small and large ( > 100,000 sample) clinical diagnostic studies
    • Proactive and experienced global project team in diagnostics
    • Currently conducting clinical IVD research in US, EU and Asia Pacific regions
    • Complete knowledge of the regulatory environments
  • Proven experience
    • Preferred provider for one of the largest diagnostic companies in the world
    • Rescued and successfully executed the validation study for a 1st in class diagnostic product
    • Consistent sample viability rates over 90%
    • Data from programs submitted to FDA has been positively received and approved
    • Recent experience includes Cardiovascular, Oncology, Central Nervous System (CNS), Gastroenterology (GI), Infectious Diseases, and Fetal Diagnostics

Proven Experience

PRA has extensive experience successfully performing clinical diagnostic studies across all phases of diagnostic research including discovery, development and validation, and commercialization. Our global teams are dedicated to the oversight and strategic planning of diagnostic studies to optimize efficiency while ensuring a positive and rewarding study experience for physicians and their patients. We are fully trained in the conduct of these studies, including customer service techniques to foster the relationship between participating physicians and sponsor. We use public health concepts in the design and execution of these studies ensuring real-world results. PRA’s global teams recognize the unique qualities and differences of diagnostic studies and are committed to implementing targeted strategies to effectively execute these important programs with the most up-to-date global regulatory requirements and successful operational tactics. Unlike other CROs, our teams understand these are not drug development studies and specialize in the unique needs of clinical diagnostic development. Our experts in the clinical in-vitro diagnostic (IVD) diagnostic and biomarker space and work with our in-house therapeutic experts to understand the standard of care to identify the right patients, in the right areas for high rates of viable sample collection. Solutions_Clinical_Diagnostics_Proven_Experience_Graphic

Centralized Site Support

PRA’s unique central monitoring approach consolidates, automates and reduces manual effort, providing high quality data that can be analyzed and acted upon (at the sample, patient, site, and project level) to help ensure high sample viability. This operational model allows us to manage both small and large diagnostic programs on a global basis to effectively and maximize site participation. Our central monitoring teams effectively and efficiently communicate and provide proactive support with potential high-volume and active sites. Through this data-driven approach it allows our teams to use real-time information from a variety of sources to focus on the most important thresholds, triggers and trends for the success of the study’s primary objective. Our Clinical Diagnostic Services scientific and operational experts implement proven strategies for site identification and selection, rapid study start-up, streamlined site management and monitoring, efficient sample management and logistics, and high-quality data collection. Relying on a range of databases, our team analyzes and cross-references diagnostic codes from protocol inclusion/exclusion criteria to understand current treatment patterns associated with specific disease states. This data-driven approach gives PRA the unique ability to determine the number of subjects being treated by population as well as their locations. By selecting sites where known patient populations exist, we greatly enhance the likelihood of successful accrual and minimize the cost of non-performing sites.

Comprehensive Sample Management

At PRA, we understand the importance of identification of high-volume sites, robust sample integrity and rapid seamless sample processing. The sample integrity of any clinical in-vitro diagnostic (IVD) being tested for research purposes is of critical importance, and demands timely and seamless sample processing throughout the entire life of the study. A well-defined plan for sample collection, processing, and logistics is critical to ensure high-quality study data. Our scientific experts look at our analytics to proactively follow the sample chain of custody processes to address issues early on, allowing us to see trends of non – viable samples for mitigation. PRA recognizes that every sample in a diagnostic study is as important as a randomized patient in a drug development clinical trial. PRA’s global diagnostics teams design and implement sample management and logistics strategies to optimize your clinical sample quality. We have successfully conducted multiple complex diagnostic studies involving on-site sample processing and our teams are well versed in Import/Export Restrictions and local regulatory environments.