Risk-Based Monitoring (RBM)
The pharmaceutical industry is facing constant challenges — particularly over the past decade — as a result of the economic downturn, the expiration of blockbuster product patents, and the resulting pressure to do more with less. These challenges extend to clinical trials, and, in particular, to the complex task of monitoring the progress of a trial at various sites.
HCL’s rHorizon, a risk-based monitoring tool, gives sponsors a holistic view of study performance with valuable insights and data visualizations. Driven by a highly configurable engine coupled to a rules database, rHorizon enables sponsors and CROs to adopt a dynamic and flexible risk-based monitoring approach throughout a trial.
- CRO Experience: The CRO division of HCL has more than 12 years of experience conducting more than 75 clinical trials in several therapeutic areas for sponsors in India, Europe, and the United States. The team works with several major pharmaceutical companies and CROs and has extensive experience conducting routine site-monitoring visits and site audits.
- Preferred Partner: HCL brings CRO domain expertise and technology under one roof to address complex problems for pharma and CRO clients. Leveraging an extensive global offshore infrastructure and network of offices in 31 countries, we provide holistic, multi-service delivery in health care.
- Ability to rate study sites on 54 criteria
- A comprehensive view of study performance with valuable insights and data and performance visualizations
- Improved quality and integrity of data (data is verified on an ongoing basis)
Business Value to Customers
- Better ability to meet trial timelines with improved site performance
- Savings of up to 55% in site-monitoring costs
- A reduction in SDV between 45% to 65%duction