TransCelerate Shares Its Take On Risk-Based Monitoring Models And Tech

With clinical trial sponsors spending a sizable chunk of their huge Phase III trial budgets on source data verification (SDV) in return for questionable benefits, risk-based monitoring is an obvious target for TransCelerate BioPharma's R&D efficiency agenda. The Big Pharma consortium has further clarified its thinking on the topic in two research papers.

TransCelerate published both papers in the Drug Information Association's Therapeutic Innovation & Regulatory Science journal. The first of the two papers--which is authored by staffers at AstraZeneca ($AZN), Eli Lilly ($LLY), Pfizer ($PFE) and other Big Pharma firms--discusses the models companies are using as they move toward centralized monitoring of clinical trials. Successful implementation of such models is vital to the strategy of lessening trial oversight costs while maintaining quality.

"Successful implementation of risk-based monitoring is dependent on being able to operationalize the concepts effectively through multiple considerations, including process, people and technology. Risk assessment, central monitoring and technology to scale the methodology are all important for success," Brett Wilson, associate director of business operations at Bristol-Myers Squibb ($BMY), said in a statement...