Xavier Flinois, president, Parexel Informatics
Biopharmaceutical companies share a common goal - make the drug development process more efficient without compromising patient safety or data quality. The operative word here is ‘efficient’ particularly in the early stages of a clinical trial when companies are challenged to conduct a range of crucial activities simultaneously. It’s a delicate period, and yet one of the few where drug developers have an opportunity to save time and resources and increase the likelihood of a successful trial from the beginning.
Every day that a treatment is delayed from reaching the market means potential financial losses amounting to millions of pounds. With such a small percentage of drugs receiving approval from regulatory agencies, the aim is to clear roadblocks and complete trials quickly so that drug sponsors can bring new and effective drugs and treatments to patients rapidly. Building, integrating and maintaining IT systems and infrastructure is a costly and complex undertaking for a biopharmaceutical company. Further, it is not always efficient to retain operational expertise in-house. Given the complexity of running clinical trials, Contract Research Organisations (CROs) like Parexel are committed to developing innovative technologies and expert services that allow for easier implementation of activities and streamlined operations.
As part of that commitment, Parexel Informatics has released an enhanced version of its ClinPhone RTSM (Randomisation and Trial Supply Management) service. A key element of the Perceptive MyTrials eClinical platform, it is designed to help clients rapidly design and implement studies by using pre-built, interactive web modules for patient, supply and site activities common to every study. Comprised of hundreds of highly configurable and pre-validated components, the service provides leading RTSM functionality to users through easy-to-use and intuitive web interfaces.
Understanding that time to market is critical, biopharmaceutical companies have been looking to their strategic partners to develop progressive technologies that help simplify drug trials from start to finish. Drawing on the experience from working on thousands of studies, Parexel Informatics has identified ways to standardise common RTSM functionality for patient screening, medication re-supply and other fundamental study activities while maintaining the flexibility to easily adapt to study-specific needs. With these capabilities in hand, pharmaceutical companies can streamline trial management activities, cutting weeks off of study start-up time and getting trials off the ground quicker than ever before.
The need to simplify drug development is ever present in today’s marketplace. Part of that pursuit is the trend toward greater standardisation and a configuration-driven approach to RTSM system development. In the past, clients required a more custom approach with a high degree of variability from study to study; however, as the industry has matured, clients are approaching RTSM design in a more consistent and standardised way, which simplifies and accelerates development.
Until now, providing a service that could generate real improvements in clinical trial efficiency and speed, while ensuring patient safety and study integrity, proved challenging. The problem came not just from the costs of pushing a drug through trials, but because of the time limit placed on patents, the pressure of weak drug pipelines and increasing market competition. Today, however, by helping pharmaceutical companies simplify the clinical trial process through innovative technology services, biopharmaceutical research organisations can significantly impact the economics of current drug development. More than that, by increasing speed to market, they can help sponsors bring important treatments to patients in need.