The RBQM platform is used to detect and monitor potential risks allowing corrective action to be taken. Teams can access information centrally, collaborate and document mitigations and remedial actions to produce a clean data set and prepare for the usual regulatory scrutiny
CluePoints says its risk-based quality management (RBQM) platform has been critical in supporting pharmaceutical companies and CROs interrogate data in global COVID-19 vaccine and antiviral antibody trials to ensure data quality and integrity.
The company says it played an important role in one of the largest of these vaccine trials which was conducted across several hundred sites and multiple countries, including most US states, and recruited tens of thousands of trial participants. The size, magnitude and critical importance of this study required a robust RBQM platform to drive regular assessments of quality, across a volume of clinical and operational data accrued at unprecedented rates. CluePoints’ software, which saw an implementation time of two weeks, allowed the client to monitor and analyse the trial data in near real-time, across all the participating sites and countries.
Patrick Hughes, co-founder and CCO at CluePoints said: “We are delighted to see that our collaboration on such momentous and exciting studies is having such a positive impact in ensuring successful approvals. Never has it been more crucial to ensure that such important studies are executed without delay and are free from any data quality and integrity issues. These sponsors and CROs required an innovative and proven approach to support early risk detection, which is exactly what CluePoints’ software is designed to do. For CluePoints to be able to support studies of this magnitude, in record time, is testament to the responsiveness, flexibility and efficiency of all stakeholders involved in these partnerships.”
The company has provided software and assistance on a number of COVID-19 studies, in addition to supporting studies directly impacted by COVID-19 restrictions and regulations. It introduced a dedicated COVID-19 package that incorporates a coronavirus-specific risk assessment template that includes a set of relevant risk categories and associated considerations gleaned from regulatory guidance documents issued by FDA, EMA, PMDA and MHRA.
Hughes continued, “Across the clinical trials industry, every effort is being made by CROs and Pharmaceutical companies to achieve unprecedented progress with vaccine trials and other COVID-19 treatments. The ability to quickly prove that therapies are safe and effective for regulatory review dramatically accelerates availability of novel medicines. Data quality and early risk detection is crucial to support the pace of such programmes and to achieve high efficacy treatments which can be made widely available in the shortest time.”