A leader from the risk-based quality management solutions provider will discuss the growing interest in the technology, during this year’s SCOPE event.
This year brought the ‘biggest momentum shift’ in the adoption of risk-based approach to trial management in the clinical research industry, says CluePoints executive.
The FDA has extended its agreement with CluePoints to augment the agency’s oversight of clinical trials using data-driven approaches, with additional testing ideas focusing on moderators of treatment effect and real-world evidence, says CCO.
Since finalizing its risk-based monitoring guidance in 2013, the FDA is providing additional information in a new Q&A that reinforces the importance of performing risk assessments for all studies.
Quanticate is using CluePoints’ software to perform data integrity checks on all types of monitoring and investigator site data as part of its new Data Quality Oversight service.
Japan-based ONO Pharmaceutical will use CluePoints’ centralized statistical monitoring platform to lead its RBM strategy over the next four years following a successful pilot study in 2017.
