As clinical trials grow in complexity and global scope, biopharmaceutical companies must continue to find new ways to streamline every part of the drug development process, including drug strategy analysis, early-phase testing, investigator selection, trial site initiation, patient recruitment, trial monitoring, clinical and drug supply logistics, and handling the growing volume of trial-related data. Sponsors also need to make earlier – and more informed – decisions about their development portfolio to improve the success rate of products reaching later-stage trials.
Effective use of innovative eClinical technology – such as Clinical Trial Management Systems (CTMS), Randomization and Trial Supply Management (RTSM), Electronic Data Collection (EDC), electronic Patient Reported Outcomes (ePRO) systems, and medical imaging – is essential to achieving the efficiencies and cost reductions mandated by the current global biopharmaceutical marketplace. By implementing advanced eClinical systems, biopharmaceutical companies are able to access the comprehensive data they need to reduce development costs, increase patient safety, support faster “Go/No-Go” decisions about potential new products, and accelerate time to market. Equally important, integrated data from the various developmental processes provides a sponsor with a broad overview of a compound’s characteristics, which is vital for understanding product safety and efficacy.
While eClinical technologies can deliver dramatic improvements in trial productivity and data accuracy, the biopharmaceutical industry must move beyond the gains provided by these individual systems if they are to achieve the cost and time savings that are necessary for their future success. The next level of clinical technology requires integrated data systems throughout the clinical enterprise – combined with innovative clinical services – to create a new operating model that increases efficiency across the development spectrum. This combination of advanced technology and expert services is essential to support the key trends in clinical development, such as: increasing emphasis on early-phase testing to better predict product safety and efficacy; larger, multinational Phase III trials; and more expansive Phase IV trials to accommodate growing regulatory requirements for data on long-term product safety and comparative effectiveness research.
PAREXEL has the eClinical systems and global clinical resources to help your company reach the next level of product development that is fully enabled by technology. Through our technology subsidiary, Perceptive Informatics, PAREXEL offers a full range of eClinical systems, including CTMS, RTSM, EDC, ePRO, web portals, and industry-leading medical imaging technologies. We will work with you to find the most appropriate solutions for your specific requirements. By leveraging the best available technologies and combining them with our clinical experience and a global infrastructure, PAREXEL is right where you need us to marshal all the necessary resources to help any biopharmaceutical company – large or small – reduce the time and cost of clinical development at every stage of the product lifecycle, anywhere in the world.
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.