Keeping the Complex Simple: Tips for CROs on Managing Data from Multiple Sources

Keeping the Complex Simple

Tips for CROs on Managing Data from Multiple Sources

Introduction

Collecting clinical trial data from multiple sources is challenging, and often a labor intensive process. Today, the majority of approaches to cleaning, standardizing and publishing data remain manual. Additionally, the number of data sources continue to grow due to industry trends such as the increase in data collection common with decentralized clinical trials (DCTs) models, biomarker management and EHRs. Contract research organizations (CROs) are now challenged to deliver high quality, cost-effective studies in an increasingly complex data environment.

Why are More Data Sources a Challenge?

Collecting clinical trial data from multiple sources is a time and resource-intensive process. The increased availability of different types of systems in clinical trials including real-world data (RWD), genomics data and virtual models has dramatically increased the number of data sources used in studies over the last several years. There is no sign of this trend slowing, as further advances in technology will only serve to increase the complexity of protocol designs, allowing researchers to look for useful data from even more sources.

However the data is collected, it will always need to be verified, cleaned and formatted to be useful to researchers. The more data being collected, and the more difficult it is to clean and standardize the data, the longer the entire process will likely take. In fact, the biggest threat posed by the increasing number of data sources, according to experts at the Tufts Center for the Study of Drug Development, is a longer database lock cycle which results in delays and increased costs. Achieving the highest level of speed and quality and the lowest cost is the reason many sponsors choose to partner with a CRO, so CRO leaders must act to identify ways to address the growing number of data sources in a way that preserves their ability to deliver speedy, high-quality clinical studies.

Tips for CROs Managing Multiple Data Sources

Following are some practical tips to help CRO leaders address the issue of collecting data from multiple, disparate data sources.

Tip No. 1

Create One Source of Truth for Cross-Functional Data Review

Instead of relying on site teams and study coordinators to manually pull data into a standard format, CROs can leverage technology solutions specifically designed to collect and standardize data. Manual data cleaning and formatting is a labor-intensive process that pulls study team members away from other important functions like patient engagement. Using a platform like eClinical Solutions’ elluminate Clinical Data Cloud, gives data management the ability to pull data from any number of data sources and standardize that data into a usable format. Non-programmers can quickly and easily set up connections to multiple data sources and perform complex data transformations to standard formats in a visual, low code environment. When clinical teams are remotely distributed across the world they all have access to the same data and information, study teams work together more effectively. Intuitive user interfaces enable data managers to easily access data from any source, clean the data, generate queries, and launch workflows all from one single source of truth.

Tip No. 2 Enable Informed Decision Making

Issues with inaccurate data recording or transcription mistakes can be minimized by providing direct access to a platform for all members of the study team. Similarly, communication challenges between teams can be reduced or even eliminated by giving direct platform access and facilitating data sharing amongst teams. For example, this will allow medical teams to conduct their reviews without the need for manual trackers while clinical operations can view prioritized queries without needing to pass Excel spreadsheets back and forth.

Tip No. 3 Take a Risk-Based Approach

As clinical data volume and variety increases, so does trial risk. Taking a risk-based approach is necessary in order to ensure patient safety and data integrity throughout the duration of a clinical trial. Risk-based Quality Management (RBQM) is a more expansive and proactive approach to Riskbased Monitoring (RBM) and enables risks to be identified before they become issues. While many Risk-based Quality Management solutions are offered as additional point-systems, implementing an RBQM solution that is integrated within a clinical data and analytics platform enables a more comprehensive approach to risk management. Performing RBQM and data management in a single platform eliminates data silos and the need to access multiple systems for quality data. Additionally, when risks are surfaced, data managers have access to all of the underlying data driving those risks at their fingertips, providing a holistic view to determine if further investigation is required. For both CROs and sponsors, the platform approach to RBQM also increases operational efficiencies. Oversight is supported by faster data flows and communication pathways to decrease error rates and enable site compliance and quality.

With the influx of clinical trial data from various sources, taking a risk-based approach allows sponsors and CROs to be more proactive and identify risks sooner. This allows for course correction earlier rather than later which not only keeps patients safer but prevents costly errors further downstream.

Tip No. 4

Visualize Better Study Performance

One of the best ways to empower informed decision-making is to give study teams the information they need fast and in a way that is immediately understandable. CROs can take advantage of technology that helps visualize data so that study team members can track performance at a glance. Data visualization can be customized based on the stakeholder audience, with clinical operations, medical team members, data managers and other stakeholders able to build out the kinds of dashboards they need to stay up to date.

Tip No. 5 Think About Who Needs to Quantify Benefits

Data managers know better than anyone the stress and headaches associated with collecting and formatting data from different sources. Giving data managers the tools they need to more effectively do their jobs is important. Platforms that not only pull data together into a single format but also allow people to configure how they view and access the data are useful. Data managers can also benefit from the ability of platforms like elluminate to templatize certain pieces of content so that it can be easily copied and used across multiple clinical studies.

A study’s medical team can also realize important benefits related to streamlining data management functions. Once data is compiled and transferred into a common format, it becomes much easier for medical teams to produce detailed reports that help them optimize care for patients involved in the study.

By maximizing the benefits for as many research stakeholders as possible, CROs can scale efficiencies across all study workflows. This helps to preserve the ability to run faster, smoother trials for Sponsors regardless of how many sources are providing data.

Case Study elluminate Makes Managing Multiple Data Sources Simple

For most CROs, the Sponsor dictates which data sources to pull information from. Sponsors typically have a preferred electronic data capture (EDC) system and they have ideas of how they want the data to be gathered. This can include traditional collection by study coordinators at clinical trial sites, or data taken directly from patients via remote technology. Either way, the data needs to be verified, cleaned and formatted in a way as to be useful for researchers, currently a lengthy and burdensome process.

One leading global CRO began exploring ways to improve efficiency through a technology partner. Specifically, they hoped to simplify and accelerate the tedious processes of manual data standardization.

This case study shares how the CRO put into practice the 5 tips to simplify managing multiple data sources.

Top Global CRO

A biopharma and medical device outsourcing service company

18,000+ employees

Operations in 50+ countries world wide

Building the Solution

The CRO selected eClinical Solutions’ elluminate Clinical Data Cloud platform to help solve these challenges and improve efficiencies. With the elluminate Data Central product, issues with inaccurate data recording or transcription mistakes could be minimized by providing direct access to the platform for both site team members and Sponsors. Data cleaning and formatting from different EDCs and other sources could be made easier via the elluminate Mapper products built-in connections with the most common data sources in the clinical research industry. The intuitive user interface would then enable data managers to easily clean data, generate queries and launch workflows all from the same platform.

Communication challenges between clinical operations and medical teams could be minimized by giving both teams access to elluminate through Data Central, facilitating the sharing of up-to-date and accurate data. This allows medical teams to conduct their reviews without the need for manual trackers and clinical operations to view prioritized queries without needing to pass Excel spreadsheets back and forth. Data Central also allowed for the visualization of data and production of ad hoc, custom graphs to help teams quickly analyze and understand the data they need.

The Results

With elluminate in place, the CRO saw immediate improvements in several areas:

■ Data managers had better access to the data from all sources

■ Data cleaning could be done with the push of a button

■ Managers could easily standardize listings and copy assets across studies, eliminating the need to redo work in many cases.

Contact eClinical Solutions to learn more about how elluminate makes managing multiple data sources simple.

CRO’s Modernize Trial Delivery

While advances in clinical research technologies and approaches are helping all stakeholders do many things faster, more efficiently and with smaller budgets, they are also adding complexity to study designs. The growing number of clinical trial data sources – multiple EDCs, remote data collection, RWD, data from wearable medical devices and more – represent exciting opportunities to find new and useful information leading to the development of safer, more effective therapies. They also represent new challenges for CROs to control clinical trial timelines and budgets. By identifying and leveraging technology platforms that pull data from disparate sources together and makes standardizations & visualizations easier and on-demand, CROs can drive efficiency across all study workflows and preserve their ability to conduct timely, cost-effective studies for Sponsors.

CROs Modernize Trial Delivery

Increase margins and data quality with the elluminate Clinical Data Cloud. Read now