ClinPhone RTSM, which has been used in more than 3,300 studies involving more than 290,000 sites and 2.4m patients, is a managed service run from Parexel’s global data center that includes access to the IRT (interactive response technology) system, with delivery, project management, and randomization and clinical supply management consultancy. For the latest update, Parexel integrated the interactive response technology acquired from ClinIntel in October 2014 with Parexel’s experience in delivering RTSM services to thousands of studies.
Kevin Bishop, Corporate Vice President, eClinical Operations at Parexel, explained to Outsourcing-Pharma.com the advantages of these services: “The randomization algorithms available within the ClinPhone RTSM service are designed to ensure that cohorts and treatment allocations areappropriately balancedaccording to the statistical objective of the study protocol and that, if required, the blind is maintained. The supply chain methodologies are designed to reduce the risk of ‘stock-out’ and keeping patients waiting for scheduled medication, while minimizing wastage of the investigational productas well as to promote the blind of the treatment group to which an individual patient has been assigned.”
Clients will see new benefits from the ClinPhone RTSM service around speed and efficiency, particularly in cutting weeks off of the standard system delivery time; configuration and customization, depending on the different phases of clinical development, regulators, regional requirements, and client or protocol needs; and rapid turnaround and minimal timeline disruption for study changes before or during the trial.
Xavier Flinois, President of Parexel Informatics, also explained that RTSM services “are critical to clinical trials, helping sponsors achieve treatment group balance, eliminate selection bias, increase the predictability of treatment allocations, and manage trial supplies, including minimizing drug wastage by enabling automated site restocking.”