Innovation Is Finally Modernizing Clinical Trials
PHILADELPHIA, March 21, 2019 /PRNewswire/ -- There is a well-known saying in the Pharmaceutical industry when confronted about the approach to executing and managing clinical trials. It is also the most expensive saying in business: "We have always done it that way".
The FDA has recently reaffirmed its commitment to modernizing clinical trials1 but acknowledges a "continued reluctance to adopt innovative approaches among sponsors and clinical research organizations (CROs). In some cases, the business model adopted by the clinical trial establishment just isn't compatible with the kind of positive but disruptive changes that certain innovations can enable." One such area is Risk Based Monitoring (RBM) which, if carried out as the Regulators intended, will enhance the overall quality of clinical trial execution and provide more efficient oversight compared to traditional on-site monitoring which is resource intensive and may account for up to a third of the total clinical trial cost.1
Vindicated by the position of bodies like the FDA and EMA, some pharmaceutical sponsors have decided to break away from the inefficient approach to managing trials forced on them by CROs and shifted toward more innovative methodologies. They are turning to companies like Transformative Pharmaceutical Solutions (TPS) which was built to challenge the antiquated methods of conducting clinical trials that have been the industry norm for the last several decades. TPS utilizes a combination of experienced people, efficient processes and proprietary technologies to offer solutions, such as:
- CROversight™ - an ICH E6(R2) compliant, technology-enabled, risk-based approach to CRO Oversight and
- iAM (integrated Adaptive Monitoring) - a solution which extends beyond traditional risk-based monitoring to provide the industry's first integrated RBM solution.
Our solutions are founded on the basis of a partnership between TPS and our Sponsors through which our sponsors recognize not only an increase in quality, but also a significant savings of 15-30% of traditional monitoring costs.
With ever-increasing pressure on Pharmaceutical companies to look at overall spend and seek ways to save money, finding a true partner that is aligned with your goals, has never been more important. Find out more by contacting [email protected].
SOURCE Transformative Pharmaceutical Solutions, LLC
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