As clinical trials continue to grow in complexity and global scope, the volume of clinical trial data is expanding exponentially. Regulatory requirements for increased safety monitoring are also increasing the amount of study data that must be gathered, organized, and analyzed. Innovative eClinical technologies are essential to manage these data requirements, reduce development costs, support faster “Go/No-Go” decisions for potential new products, and increase efficiency throughout the clinical trial process.
PAREXEL’s technology subsidiary, Perceptive Informatics, is the leading eClinical solutions provider for the biopharmaceuticals industry, with a broad array of innovative products that increase trial efficiency and improve data management. Perceptive’s product portfolio is built on cutting-edge technology, combined with PAREXEL’s extensive medical and clinical expertise and a deep understanding of the regulatory environment. These innovative products include:
The ClinPhone Randomization solution has been used in more than 2,800 clinical trials, helping pharmaceutical sponsors achieve treatment group balance, eliminate selection bias, and limit the predictability of treatment allocations. The Trial Supply Management solution reduces waste and improves the efficiency of trial supply logistics by automating the restocking of sites and depots.
A clinical trial management system plays a vital role in helping biopharmaceutical companies to track and record the complex array of administrative, financial, site-related, and other data that is critical for the efficient monitoring, and management of clinical trials. IMPACT CTMS provides the top global pharmaceutical companies a flexible solution with feature breadth and depth. IMPACT CTMS is available as a SaaS solution and can also be implemented as an on-premise solution.
Electronic Data Capture (EDC) solutions add tremendous efficiency to the data collection and cleaning processes of a clinical trial by replacing paper Case Report Forms (CRFs) with an electronic CRF for recording clinical data. Perceptive Informatics' DataLabs® EDC solution improves data accuracy, reduces redundancies, facilitates rapid data review and query resolution, and cuts the time to database lock.
The use of patient self-reported data systems is growing rapidly, especially for larger, late-stage studies. Perceptive Informatics’ wide array of ePRO solutions – including IVRS, IWRS, and hand-held systems such as PDAs) – have successfully supported clinical trials of all sizes and complexities worldwide, in every major therapeutic area.
Clinical study sponsors increasingly rely on advanced medical imaging technologies to serve as surrogate endpoints for studies of product efficacy and safety. Perceptive Informatics' therapeutic and medical imaging experts provide a range of capabilities in the application of the latest techniques to support every stage of clinical development. Our experience using novel modalities to accelerate early decisions about therapeutic agents is particularly valuable in today’s pressure-filled development environment.
Perceptive Informatics also provides powerful eClinical integration solutions to provide seamless, automated exchange of data, such as the Clinical Technology Integration Platform (CTIP) – a proven middleware system that enables diverse clinical trial applications to work together synergistically.
We are a leading global bio/pharmaceutical services organization that helps clients expedite time-to-market through our development and launch services. These include a broad range of clinical development capabilities, integrated advanced technologies, regulatory affairs consulting, and commercialization services.