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As guidance for Industry has evolved, ICH E6 (R2) for example, presenting new recommendations for ensuring patient safety, organizations have faced significant challenges in translating the guidance into tangible operating practices to satisfy the requirement of an entirely Risk-Based Approach to Study Execution (RBx). Being the leader in Risk-Based Quality Management Solutions, we’ve garnered a wealth of experience in the space, perfectly positioning us to offer support in preparing for site inspections and implementing Risk-Based Monitoring (RBM)/Risk-Based Study Execution (RBx).

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Key Risk Indicators

Central Monitoring

CluePoints can support your proposed or ongoing clinical trial by providing the platform as a service. Our industry expert Data Analysts will configure the system on your behalf before processing your clinical and operational data to report the findings back to you. Let CluePoints inform you as to where to focus your operational activities to maximise data quality and ensure overall trial success.

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RBM/RBx Implementation

CluePoints is the industry leader in RBM/RBx implementation and our professional services team are available to guide your journey to implementation success. Whether that is helping define your holistic RBx strategy, aligning with ICH E6 (R2) guidance, or simply helping define tactical monitoring approaches and KRIs, the CluePoints professional services team have the historical experience to support you.

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Study Dashboard
Central Statistical Monitoring Screenshot

Site Inspection Readiness

Your trial may be complete, but do you have full visibility on site performance and the quality of the data supplied?  Will any of your sites stand out when your data is reviewed by the regulators, leading to a site inspection? Our Site Inspection Readiness service can interrogate all of your clinical and operational data to identify sites at risk of inspection, helping you proactively prepare in advance

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Mergers & Acquisitions

Does the clinical data that supports your proposed acquisition contain underlying issues that will compromise its ability to eventually support a successful regulatory submission? CluePoints can test the available data to look for atypical patterns, or absence thereof which help verify the robustness of the data and associated processes.

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Central Statistical Monitoring Screenshot

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Whether you’re looking to get started or need support, we’re here to help!

Featured Whitepaper

ICH E6 (R2)

Created in conjunction with our peers at TUFTS Center for the Study of Drug Development, this paper provides insights on how companies are responding to ICH E6 (R2) and information on the key themes on adoption.

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Featured Webinar

ICH E6 (R2)

This recorded webinar covers all of the frequently asked Questions about ICH E6 (R2), Risk-Based Study Execution (RBx) and what’s required from a people, process & technology standpoint.

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