4 Ways to Improve Medical Review with a Clinical Data Workbench

When it comes to clinical development success, medical review of clinical trial data is of the utmost importance. In order to effectively understand the holistic patient experience and improve your speed-to-analytics timeline, real-time access and analysis of all clinical data sources are a must. Unfortunately, many medical reviewers struggle with access to all the varying data sources and systems.

A modern approach to medical review moves organizations away from time-consuming, manual data review processes and instead enables clinical trials to adopt agile data management processes that ensure all parties are looking at all data sources in real-time.

In a perfect world, medical reviewers could solely focus on ensuring patient safety and perfecting the scientific objectives of the trial as opposed to managing and wrangling the data. But with the influx of data sources, types, and an increase in data velocity, it’s becoming increasingly difficult for medical reviewers to focus on their core responsibilities. In turn, this impacts the safety, integrity, and timeliness of data, all of which can result in trial delays, quality challenges and missed opportunities. .

Let’s take a closer look at four unique ways a modern approach simplifies and streamlines the medical monitoring process to ultimately help deliver a richer clinical understanding of the patient’s trial experience and allows medical reviewers to focus on patient safety and doing good science.

1.   A Centralized Source of Truth

Achieving clinical data visibility, traceability, transformation, and analysis is made a whole lot more difficult when your data is not consolidated and standardized. With an influx of trial data coming from an increasing number of sources and systems, it’s never been more important for medical reviewers to have near real-time access to their data for faster and easier medical review.

Having a centralized source of truth for all your trial data from every source means having one place for integrated medical review — from  patient profiles to cohort ad safety analytics and issue management.

With a clinical data workbench like elluminate^® Data Central, all data types and formats are standardized and consolidated within a central source of truth. This minimizes the likelihood of inconsistent reporting or inaccurate data across teams and gives medical reviewers and data managers a simplified way to work confidently and collaboratively together. In turn, elluminate enables continuous oversight and ever-improving data quality to ensure everyone is on the same page.

2.   Enhanced Data Accuracy

Once all of your trial data has been centralized and mapped into standard formats, you’re more likely to avoid issues around data integrity and traceability. Giving everyone oversight into where certain data points originated, how they were mapped are combined, and what they communicate ensures more accurate insights when it’s time for final analysis and submissions deliverables.

Additionally, ensuring accurate data is a must for medical reviewers who not only need to demonstrate to auditors that they’re compliant with regulatory guidelines for oversight, but also to continuously monitor patient safety. With elluminate, you spend your time collaborating on what the data you review means, increasing the quality of your review and reducing the likelihood of downstream issues post database lock. 

3.   Optimized Issues Management

Inevitably, issues and queries will arise throughout your clinical trials. And when they do, it’s important that you’re able to work through them quickly and efficiently to ensure that trials progress smoothly. Through Data Central, medical reviewers can collaborate with data managers to effectively track, manage, and resolve queries and issues.

Since all of your disparate data systems, spreadsheets, and listings are centralized within elluminate, you’re able to easily understand and rectify data issues and queries without having to track them down. The time savings clinical trials can achieve by avoiding tedious issue management responsibilities can greatly benefit medical reviewers who want to spend less time troubleshooting and more time delivering results.

Being able to raise and process EDC queries directly in elluminate Data Central, a clinical data workbench, in addition to quickly identifying any data changes since the last review, enables medical reviewers to improve their speed-to-analytics timeline, better identify patient trends, and spot red flags before they cause problems.

If you want to see how elluminate Data Central delivers results in a real-world setting, be sure to check out our case study with Wave Life Sciences.

4.   Safeguard Patients

Ultimately, your clinical trials strive to prevent and or treat disease more effectively, which isn’t possible without the help of willing patients. elluminate was designed with industry standards in mind to safeguard patients and ensure their information is handled properly.

Within elluminate, you can create and access customizable graphical patient profiles, including single and ongoing events, lab data, and more. New patient profiles can be configured directly within the platform, and patient data can be reviewed within ellluminate Data Central to identify trends and analyses for safety oversight.

How you create, store, and access patient data will dictate the success and validity of your final outcomes. Through a centralized platform that houses all clinical trial data, medical reviewers can more easily analyze data from their patients and sites that demonstrate outlying or unexpected values that require additional follow up for safety review.

elluminate: Centralize and Simplify Medical Review