CluePoints, a company providing risk-based study execution (RBx) and risk-based quality management (RBQM) software for clinical trials has won the best Contract Research Organization (CRO) in the specialist providers category at Citeline’s 2023 SCRIP...
Updated guidelines for risk-based quality management (RBQM) are much more than just for monitoring purposes and can show quality by design concepts, save immeasurable time on manpower and shows there has been a complete mindset shift within the last 15...
CluePoints is continuing to invest in artificial intelligence (AI) and machine learning (ML) they say they want to help clients 'extract every drop of potential from the RBQM-driven interrogation of their own datasets'. It says it recognizes...
A leader from the RBQM solutions specialists offers a preview of his SCOPE 2022 presentation on tools suited to decentralized trial design and management.
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.
Parexel and CluePoints to use CSM solutions for preclinical and clinical risk-based monitoring, after regulatory guidelines impact mutual acceptance of data across the US, EU and Japan.
Risk-based monitoring should be described as a “best practice,” says ACRO, which recently released a survey that found the majority of new trial starts in 2018 employed some form of RBM.
ICH E6 R2 sparked a paradigm shift, though 2019 will see the clinical trials industry transition from a risk-based monitoring approach to risk-based quality management.
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.
An analysis of clinical trial data by Medidata and industry group TransCelerate BioPharma has found that the value of source document verification (SDV) in a risk-based approach to clinical trial site monitoring is minimal.
As CROs and sponsors look to use risk-based monitoring more for clinical trials, the role of clinical research associates (CRAs) will shift dramatically, experts said Wednesday.
Medidata will provide metrics and analytics help to industry group TransCelerate to answer questions on the benefits and challenges associated with a risk-based approach to monitoring of clinical trial sites.
CROs and sponsors that apply a risk-based algorithm to monitoring clinical study sites could reduce the deployment of research associates and target more high-risk patients and sites, according to a new report from PricewaterhouseCoopers (PwC).
