Written by Andrea McSweeney, Vice President of Customer Success – Channel, CluePoints
Contract research organizations (CROs) are uniquely positioned to partner with sponsors on risk assessment and monitoring activities—but they must have the systems in place to ensure subject safety and data quality across their study portfolios.
CluePoints can offer the tools to aggregate data in a scalable, repeatable way across unique sponsor engagements. Using our risk-based quality management (RBQM) technology allows CROs to unlock data and grow their clinical expertise. CluePoints advanced data analytics, while deployed on a single study, can become a robust knowledge base when CROs take a programmatic approach and place their clinical portfolio on the platform. In addition, data collection across unique studies can be rolled into organizational level dashboards to aid the CRO in identifying common trends that otherwise may not be communicated from one study team to another within therapeutic areas and different indications.
Our clients who have adopted the CluePoints platform have been empowered to gain deeper insights and proactively manage clinical and operational risks to correctly apportion resources and deliver higher quality outcomes. Here are ten benefits CROs can gain from deploying a risk-based approach facilitated by technology:
1) Greater Regulatory Compliance
RBQM was formalized in the ICH Guideline for Good Clinical Practice E6 (R2) released in 2016. We expect to see an even more stringent stance on standardizing risk-based approaches embedded within the soon-to-be-released ICH E6 (R3) update later this year as we have a longstanding relationship with the FDA. Most recently, the UK’s MHRA has cited CluePoints as part of the Good Clinical Practice guidance for quality oversight and monitoring activities as an example of the power of statistical central monitoring technology.
This means the pressure is on sponsors and CROs to ensure studies meet the standards being set. As a result, we see a surge of interest in our configurable off-the-shelf technology solution to facilitate a CRO’s RBQM framework and establish the relevant processes.
2) Improved Use of Resources
Central monitoring is a cost-effective and efficient solution—it allows a more significant number of studies to be managed by central resources and is scalable for greater flexibility. RBQM solutions enable disparate teams to operate within the same framework and systematically focus on critical data and processes to help ensure study teams can identify issues that could affect the validity of the clinical trial data. This enables greater study team collaboration and the ability to proactively document and address identified study risks. In addition, having a centralized resource to facilitate data oversight reduces the amount of source data verification (SDV) needed, allowing on-site monitors to focus their attention on specific site issues and dedicate their time to high-impact oversight activities.
3) Increased Data Oversight
Central monitoring facilitated by CluePoints technology offers a “big picture” macro view across all patients, sites, and regions instead of the traditional micro view of on-site data review. As a result, it makes trends or outlying sites more visible, enabling a rapid response to adjust, correct, and provide a vital audit trail to submit as part of the regulatory package. As a result, CluePoints technology allows sponsors to interrogate clinical and operational data, increasing efficiency, improving patient safety, and reducing costs.
4) New Revenue Stream
Adopting a centralized approach expands CROs’ capability and can be used to complement on-site monitoring and site management. Running more efficient trials results in sponsors reserving their leftover budget for further studies. In addition, CROs are becoming more aware of the benefits of risk-based approaches and how they refocus CRO efforts more efficiently and save time by providing guidance on what to look for and where to search instead of making on-site monitoring obsolete.
Further clinical innovation, such as decentralized clinical trials, will also heavily affect CRO working models. CROs that move toward central monitoring will ensure that they’re well-positioned to provide data oversight without physical site data review. CROs who embrace risk-based approaches won’t miss out on this alternate source of revenue.
5) Process Standardization
While the approaches of different sponsors and CROs may vary, a consistent framework such as the one provided by CluePoints can help organizations standardize processes across their entire portfolio. Of course, there is still the option to tailor and adapt when required. The centralized data monitoring enables individual study teams to share a baseline approach and develop templates for use throughout the process, allowing for repeatable outcomes and measurements. It also enables:
- Proactive planning – standardized systems allow for more robust risk identification, meaning anticipated issues can be avoided and any anomalies can be rapidly identified (and corrected)
- Shorter studies – faster study timelines can be achieved with improved data oversight and management; reviewing data throughout the study execution brings fewer surprises in the end
- More efficient on-site activity – by monitoring data quality centrally, site monitors have more time to dedicate to targeted training, protocol review, and patient safety oversight as required, instead of devoting vast amounts of time to SDV, which is no guarantee of overall study data quality.
6) Earlier Risk Detection
Using CluePoints’ technology to facilitate data review enables study teams to detect risks and trends earlier, allowing actionable steps to be taken that mitigate and possibly prevent other operational risks that may compromise the integrity of the study, saving organizations time and money.
7) Powerful Central Statistical Monitoring Capability
CluePoints’ Data Quality Assessments allow organizations to boil the ocean. This failsafe sweep of all data reviews captures risk factors and enables unforeseen issues to be identified and dealt with.
8) Improved Communication
A single shared platform allows information to be easily communicated to stakeholders to facilitate sponsor or CRO study management and better collaboration. In addition, it provides greater transparency, with communal access to study data, meaning actions and issue management can be quickly and succinctly communicated between different parties—what we call a single source of truth. This organized presentation of data and findings means we can bid farewell to unauditable spreadsheets or multiple systems containing discrete sources of information.
9) Greater Insights
This single source of truth empowers organizations to better understand how individual studies are performing by leveraging CluePoints’ Beyond dashboard, meaning CROs can review multiple studies and spot trends via a macro view of the risks. Findings can be added to ongoing risk assessments and inform future studies across the portfolio for continued improvements.
10) Our People
Thanks to the depth of our expertise here at CluePoints, we’re highly skilled at leading CROs through the RBQM process and managing the change required to support this approach. CluePoints helps ensure the organizations we work with access the resources they need to be a trusted development partner. Whether organizations are new to the risk-based approach or seasoned experts, we become an extension of their team, guiding them in RBQM best practices.
We consistently receive positive feedback about our Knowledge Transfer programs, allowing CROs to be autonomous providers of both the approach and technology. We empower CROs to define their operational and technological processes to conduct the most efficient and effective studies that support the needs of their clients and improve outcomes for all parties involved.
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See how CluePoints’ technology and RBQM approach can benefit your upcoming clinical trials. Contact us today to learn more, request a demo, and begin our journey together.