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A technology-driven approach to oversight of vendors and sites can provide sponsors with timely and proactive solutions toward minimizing risks.
With increased complexities of study protocols and involvement of one or more vendors for clinical trials, oversight is becoming a complicated but an important task for sponsors to ensure study success. Adequate oversight is essential to achieve the planned objectives, minimize risks and maximize the returns on the drug, device development projects. The regulators are encouraging sponsors to have an appropriate oversight approach to ensure better compliance, improve quality and patient safety. Even ICH GCP E6 R2 has added oversight as the important aspect of the clinical trials along with design, conduct, recording and reporting to ensure human subject protection and reliability of trial results. The poor oversight of the vendors or sites leads to issues related to compliance, quality, increased cycle time, budget overruns and ultimately failing to achieve the expected objectives of drug/device development project.
The key is to ensure adequate and timely oversight of vendor/s and sites, and therefore, it is important to use right technology to get the oversight reports directly from primary data sources like EDC, CTMS and IRT, etc., to obtain almost real time insights about performance, instead of depending on the reports coming from vendors or study team for oversight purpose. With the advent of technology like analytics and risk management tools, this oversight can be done efficiently and independently.
Oversight Plan - One of the essential aspects of oversight plan is to decide key performance areas or critical success factors to track through the oversight process. These key areas are include quality, safety, timelines, financials or any other specific area related to vendors, sites performance and is vital for a study success. Initial holistic approaches for project, system risk identification and assessment is helpful in deciding critical success factor for oversight purpose.
Key Performance Indicators (KPIs) - Identification of right KPIs or metrics which will facilitate adequate amount of oversight of those critical areas is very important. The KPIs should allow easy assessment of performance and identification of risk/issue related to those key areas. At the same time, KPIs should be “insightful” to plan risk, issue controlling measures or take corrective and preventive actions to ensure the achievement of critical success factors. Some of the examples of KPIs for oversight purpose are – number of protocol deviation/violation per patient (quality) or critical/major audit finding per site (quality), time for key milestones like data base lock (timeline) or change in monitoring visits number (budgetary) or number of change orders generated by vendor (budgetary).
Once we decide the KPI, it is imperative to identify the primary, right data sources (EDC, CTMS, IRT, eDiary etc.) and data points to get almost real time and meaningful reports related to those KPIs planned for the oversight purpose.
Use of robust technology is the key - A right mix of technology with analytics and visualization that can also integrate risk management would be helpful. The technology should facilitate collection of the relevant data, handle required data volume, analyze and visualize oversight reports on a real-time basis to assess the vendor/s, sites performance. Some of the key features of such technology would be could include the following:
Oversight is an essential activity in regulatory perspective as well as to ensure return on investment. Technology-driven, independent approach supports adequate and timely oversights and also helps to take proactive actions to control the risks which might affect success of the study/project.
Ashok Ghone, Ph.D. is Vice-President, Global Services at MakroCare USA. firstname.lastname@example.org