Reining in the CRO oversight quagmire

Craig Morgan
Head of Marketing, Study Startup

As the complexity of clinical trials continues to increase, the importance of contract research organizations (CROs) to the pharmaceutical industry has also grown. This outsourcing trend is being driven in response to the ever-increasing size, regulatory demands, duration, and cost of clinical trials. Outsourcing allows pharmaceutical companies to utilize on-demand services, while improving operational efficiencies by accessing therapeutic expertise and geographic reach. This reflects a sharper focus on core competencies and a shift to allow CROs to manage and conduct clinical trials.

The relationship between sponsors and CROs is strengthening as outsourcing becomes a clinical trial mainstay. Yet, outsourcing of clinical trials introduces additional complexities around quality, oversight, collaboration, and governance. With outsourcing, processes and systems are often duplicated or disparate. Because sponsors often have multiple studies running concurrently with multiple CROs, oversight is complicated. Sponsors can’t benchmark CRO performance across their studies and therefore are unable to build-up institutional knowledge and competitive business intelligence, nor can they monitor ongoing performance to identify potential bottlenecks, having to rely instead on scheduled, and frequently outdated, status reports. Communication and transparency are required to move the clinical trial forward efficiently, but how can you do this when you’re working with multiple CROs all using inconsistent reporting conventions?

Simply handing off multi-million-dollar studies to CROs without carefully crafted plans for communications and reporting operational data as the study unfolds is hardly a wise move, yet what kind of oversight is needed?

Today, clinical operations teams are drowning in data but starving for information, at a time of intense pressure to speed clinical trials and restrain costs. Having technology that can automate or assist in the timely monitoring of trials is a huge improvement over the current status quo of manually generated reports and status meetings, which are cumbersome and erroneous, not to mention only provide a dated view of trial performance. Technology which facilitates centralized communications and collaborations in real-time is essential in order to keep all stakeholders aligned on shared goals and processes.

Technologies that track how studies unfold are essential but putting that information to good use requires turning real-time visibility into actionable data. Risk mitigation is therefore optimal using systems which can provide timely, preferably real-time data on trial bottlenecks, which indicate red flags to be reviewed and addressed or at least tracked carefully throughout the trial. The power conferred by such real-time intelligence directly impacts the efficiency, cost and reliability of clinical operations. This requires access to critical information allowing stakeholders to be proactive in making decisions faster and better, based on fact.

An effective study startup process (encompassing the activities associated with site identification, feasibility assessment, selection, and activation) is fundamental to the overall operational success of a clinical trial as it is the most impactful phase of the trial’s lifecycle. As stakeholders are increasingly aware that better study startup processes are linked to shorter clinical timelines, the emphasis has been shifting in that direction.

Purpose-built study startup systems that utilize advances in data analytics and visualization have now become an integral component of decision support systems, aiding compliance and affording clinical research teams an opportunity to intervene before the effects of a risk have been incurred. Of paramount importance to project managers in this endeavor are analytical dashboards, but like the data they display, dashboards alone do not provide value; it’s up to experienced clinicians to distill insights.

The advantages of analytical dashboards to monitor the progression of a trial and compliance with budget/timeline goals cannot be overstated. It aids important communication and planning activities amongst all stakeholders.

When utilizing operational metrics, dashboards capture and display metrics associated with an increasingly smaller slice of time/artifact activity, which is critical when reviewing processes for optimization and in providing an organization with a competitive edge. Performance metrics must be data-driven, standardized across studies, indication, and therapeutic areas, and timely. They must also, importantly, facilitate a forum for discussion. Finding actionable insights is driven as much by smart humans as it is by actual data.

Benchmarking trial data from CROs allows sponsors to assess their performance and progress against historical data. It is this ability to see at a glance if they are on par with trials of a similar size, geographic footprint, therapeutic area, etc., that provides powerful insights. This is particularly important in the case of a sponsor needing to justify a continued outsourcing relationship or in proactively planning for future studies. A review of benchmarking data may indicate red flags not otherwise raised during the monitoring of the trial and may be country specific.

By transitioning to a solution used by all CROs across the portfolio, oversight improves, and sponsors can build reliable institutional knowledge about CRO performance. The standardization of CRO data aids sponsors in the oversight/project management function and helps facilitate meaningful conversations about their outsourced studies with their CRO partners.

These analytical dashboards and associated metrics provide sponsors with a consolidated view of their outsourced study portfolio across all of their CRO partners to view status of submissions, submission approvals, contracts, and release packages, with drill-down capabilities to access specific details (Fig 1). Proactive planning and operational efficiency is enhanced by viewing all completed, upcoming, and past due milestones and submissions (Fig 2), and by being able to view projected completion dates for all release packages, view and export status of all documents in a release package, and being able to analyze common document rejection reasons (Fig 3).

Fig 1. Standardization of CRO data enables a single report to be generated for all concurrent outsourced studies

Fig 2. View projected completion dates for all milestones and submissions in a study

Fig 3. View release package status across your outsourced studies

Thorny budget and contract negotiations between sites, CROs and sponsors are the single greatest cause of delays in starting clinical trials. By viewing site contracts that have pending actions sponsors can see the status of contract activities and where next-step activities currently reside, helping to facilitate site activation monitoring, follow-up discussions, or nudges (Fig 4).

Fig 4. View status of each site contract and budget by country

Benchmarking is the precursor to predictive analytics, enabling clinical research teams to estimate future outcomes based on their current state of progress. This is critical to risk mitigation and a preemptive weapon in the fight against the dreaded rescue study. Leveraging predictive analytics clinical operations teams can be guided in milestone planning with in-application planning assistance.

Milestone predictions guide clinicians in their daily activities by using machine learning to automatically plan site activation outcomes with system generated milestone suggested dates (Fig 5). The observed differentials provide an ideal forum for discussion between stakeholders and provide a rich example of insights that have the potential to decrease cycle times.

Fig 5. View predicated, planned and actual milestone dates across your outsourced study portfolio

Analytical dashboards are essential tools for improving transparency, communication and collaborations with CROs by providing sponsors with timely status updates and operational insights into outsourced studies, leading to enhanced performance and governance. Through visually-rich analytics and dashboards, sponsors are able to help transition their clinical operations teams from an environment that is reactive to one that is more proactive by shedding light on process bottlenecks and offering insights into complex, multi-site, global, and concurrently run clinical trials in real-time. They relegate descriptive, static status reports to the archives and empower data-based decision making – driving competitive advantage and optimal proactive planning in study execution. For sponsors, improving oversight of this function means real-time visibility into study startup progress, affording greater confidence in the communications they have with their CROs partners. After all, if your competitive advantage is built on poor quality data it might be more perception than reality.

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