Rethinking Clinical Trial Management Systems: Improving the Value of Clinical Operations Data

As the clinical trial industry becomes increasingly complex, more sponsors are focusing their efforts on oversight and insights. Contending with new formats like decentralized trials and electronic data capture — as well as the growing volume, velocity, and variety of patient data — means that they’re leaving the data ingestion, standardization, and analysis to third-party providers.

This has resulted in manually maintained, static Excel trackers from Clinical Research Organizations (CROs) and development partners, assembled using outdated dashboards based on month-old data. These are poor indicators of current trial performance which then prevent trial managers from implementing proactive, risk-based management and analysis.

As leaders in clinical trial data management solutions, we’ve had many conversations with life sciences leaders who are looking for increased visibility into their operational data. Some have implemented in-house source solutions for partners and vendors to use. In these circumstances, vendors log in to the organizations’ systems and use the organizations’ technology to manage trials.

Although this gives organizations ownership of their data, vendors are then forced to use a new solution that they may be unfamiliar with. It becomes cumbersome to adopt and adapt to a different solution for each client that the CRO works with. It also doesn’t necessarily solve the issue of static reporting. Although the organization may have great reports from each vendor, there’s still the issue of compiling data from multiple sources.

A better solution is to adopt clinical data management software that ingests and integrates operational data from a wide variety of sources and vendors. With increased operational oversight, these improved Clinical Trial Management System (CTMS) can automate operational data pipelines and reduce the time spent on manual data tracking processes to accelerate clinical development. That’s why eClinical Solutions has released the elluminate CTMS Insights module. Benefits to this automated clinical data platform include:

1. Increased operational oversight and control

When working with CROs, sponsors rely on them for important trial information such as site selection, patient enrollment, drop out, and completion and compliance data. This involves using multiple complicated systems to aggregate all data. By automating operational data from numerous systems, CTMS Insights enables organizations to integrate data and learn from all operational data over time. It provides a single source of truth to improve audit trails throughout the clinical trial.

2. Improved trial performance

An operational data repository allows clinical trial managers and operations leaders to analyze and manage data at the investigational product, program, and study levels to inform new trial planning. This allows for faster trial design, leading to accelerated time to market for drugs and therapies.

3. Optimized resources

Traditional CMS solutions focus on management of clinical trials, but many small- to mid-sized pharmaceuticals are relying on partners and vendors to manage clinical monitoring. They really need solutions that focus on oversight and insights, rather than management. CTMS Insights pulls data from a variety of sources in real time. With self-service access to standard analytics, companies are liberated from relying on outsourced partners for access and insights into clinical operations data and manually created trackers.

Leveraging ​​the power of the elluminate Clinical Data Cloud, it is capable of automated data ingestion from a wide variety of sources, including CRO’s CTMS systems. By automating error-prone and repetitive processes — such as updating manual trackers and producing static reports — sponsors have the time and ability to draw greater insights from trial data. elluminate CTMS saves time and delivers self-service access to operational data-driven trends and insights.

Designed for organizations looking to own and mine their operations data for performance metrics without relying on downloads and spreadsheets, CTMS Insights helps to scale through data-driven operational excellence. Watch our latest on-demand webinar to learn how to trial performance and improve data driven decisions.