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The Rise of Risk Based Monitoring [Infographic]

Thomas Underwood

Risk Based Monitoring is a term that is not new to the pharmaceutical industry. With increasing demand for budget reduction and reduced time to submission in drug development, both sponsors and vendors are seeking ways to reduce costs whilst still maintaining and potentially improving the quality of the data collected in clinical trials. Study costs can rise considerably for clinical trials with a large number of sites, especially across multiple countries. Risk Based Monitoring can reduce study costs considerably as there is a reduction in the need for CRAs to travel to sites, especially when coupled with a remote monitoring component. Also a reduction in the need to monitor all clinical trial sites and 100% of trial data, as those which are identified as more risk prone are visited more frequently according to targeted or triggered formulas. Even the FDA understands and encourages the desire to move away from 100% source data verification. Why therefore is the general mind-set in clinical operations exhibiting a degree of inertia to change with regard to RBM techniques? 

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Topics: Clinical Trials, Remote Monitoring, Electronic Data Capture, e-Clinical, Source Data Verification (SDV), Adverse Events (AEs), On-Site Monitoring, Serious Adverse Events (SAEs), Clinical Trial Phases, Additional Monitoring, Phase 2 Studies, Technology Trends, CRAs, Risk Based Monitoring

The Rise of Risk-Based Monitoring in Clinical Trials

Thomas Underwood

During drug development the cost of clinical trials can rise significantly for studies that require several monitoring visits across multiple sites. Traditional monitoring techniques account for a large portion of these costs. Pharmaceutical companies absorb the costs of travel when their own Clinical Research Associates (CRAs) visit sites, while CROs normally charge clients these travel costs as pass through charges. It is estimated that remote monitoring in clinical trials could reduce travel costs (including unproductive time spent travelling) by up to 30%, and in theory the practice should be scalable across small to large clinical studies over several clinical trial phases[1]. The unproductive travel time saved also means CRAs have more time available for monitoring activities, aiding with the current CRA shortages[2].

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Topics: Clinical Trials, Remote Monitoring, Electronic Data Capture, e-Clinical, Source Data Verification (SDV), Adverse Events (AEs), On-Site Monitoring, Serious Adverse Events (SAEs), Clinical Trial Phases, Additional Monitoring, Phase 2 Studies, Technology Trends, CRAs, Risk Based Monitoring

The Promise of Electronic Data Capture - How Soon is Now?

Stuart Cook

 

Do you remember where you were when you heard the slogan, ‘Cleaner data faster’? That was the promise of Electronic Data Capture (EDC). A brave new world. Those of us at the forefront of EDC, or Remote Data Entry as it really was, may well remember the change resistance demonstrated by various stakeholders combined with the enthusiasm of early adopters.

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Topics: CDISC, Phase I Studies, Case Report Form (CRF), Remote Monitoring, Remote Data Capture, Tablets, Electronic Data Capture, ePRO, e-Clinical, eCRF, Electronic Medical Record (EMR), Source Data Verification (SDV)

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