The Drawbacks of Working with Siloed Data for Medical Monitors

In an increasingly outsourced world, clinical trial sponsors are relinquishing control of their clinical trial participant data to third parties in order to free up their teams to focus on the critical tasks in front of them. Seeing as the amount of clinical data used per trial has increased by 183% in the last 10 years, organizations are turning to CROs and their vendors to handle this massive influx of data. But with more CROs handling your data comes greater challenges surrounding how you access, analyze, and report on that data holistically.

Needless to say, the proliferation of clinical trial data and the reliance on outsourced vendors have made clinical trial management wildly complex.

Let’s take a closer look at some of the drawbacks medical monitors can experience when working with siloed data from multiple sources and vendors. After reading, you’ll not only understand the consequences of failing to centralize and consolidate disparate data sources, but you’ll know how to break down data silos for peak clinical trial efficiency.

Disjointed Data Access & Analysis

When patient data is housed in varying systems, it makes it difficult for medical monitors to access what they need, when they need it. A central source of truth delivers a critical mass of knowledge that enables medical monitors to reach faster insights with fewer obstacles. Without it, data analyses are made increasingly difficult, with medical monitors having to spend more time searching for and standardizing patient data rather than analyzing it.

A fragmented critical mass of knowledge among medical monitors is hard to avoid when it’s not clear which critical data points are accurate and up-to-date. Needing quick and clean access to patient data in order to make necessary evaluations is critical to a medical monitor’s role. When that data is siloed, it can lead to inconsistent versioning, slower data access, and inaccurate findings, all of which lessen the overall value of a clinical trial and its outcomes.

To achieve a seamless, real-time review of clinical trial data that enables medical monitors to efficiently identify necessary data takeaways, you need a clinical data management system that minimizes the confusion (and headaches) around patient data. Doing so can improve your speed-to-analytics timeline and help you identify trial trends and safety red flags more quickly.

Poor Data Integrity

Data integrity is ultimately what enables your clinical trials to actually make a difference in peoples’ lives. Having a rich clinical understanding of the patient experience isn’t enough when the data that’s generated from a trial can’t be trusted. Throughout the data lifecycle, from initial creation to final submissions, data integrity needs to be a top priority. Unfortunately, with an increasing number of CROs and outsourced vendors handling patient data, medical monitors are having trouble assuring data integrity.

When patient data is siloed in varying databases, inconsistencies in internal reporting and analysis are more likely to occur. Speed is vitally important when it comes to the quality of a clinical trial. As time passes, patient data can become more difficult to connect and, in turn, less valuable. And when patient data isn’t universally updated and synced across disparate systems, medical monitors have a hard time knowing which data points to act on.

A centralized data management system that routinely and reliably ingests data takes the guesswork out of data analysis and ensures medical monitors are working with real-time, accurate data points that enable faster analysis and stronger insights. Breaking down the silos between patient data ensures data integrity is never something your clinical trial needs to worry about.

Duplicated Efforts

Maximizing time, money, and resources within your clinical trial is likely top-of-mind for most clinical trial sponsors. Progressing smoothly throughout your clinical trial depends on each team member carrying out their responsibilities in a coordinated, cohesive fashion. It also means that everyone needs to be plugged into what other team members are working on in order to avoid duplicated efforts. Ideally, your teams can communicate directly from a centralized tool as they come across things that need to be researched or queried.

But without a centralized, modern clinical trial platform for data collection and analysis, clinical trial teams may take it on themselves to determine which data points are accurate and how to progress with their findings. And when team members fail to report their efforts across the organization, it’s possible that someone else within the clinical trial is doing the same work in parallel. This is where unified access to centralized data can make all the difference.

In order to avoid wasted time and resources on duplicated efforts, medical monitors need to consolidate incoming and outgoing communication within a single portal. This not only works to reduce friction surrounding disparate communication but also breaks down data silos and ensures consistency across clinical trial teams and key stakeholders.

Compliance Issues

Suffice to say, siloed data keeps your clinical trials from being their best. On top of that, disparate patient data also puts your organization at risk for regulatory compliance issues. Monitoring and mitigating risks with efficiency, accuracy, and ease are difficult when trial data sources aren’t centralized.

By failing to break down data silos, you’re leaving the door open for non-compliance and possible misrepresentation of critical data, both of which can stop your clinical trial work in its tracks.

In order to proactively manage risk throughout the clinical trial lifecycle, a more focused, data-driven monitoring effort needs to be taken that enables active oversight and ensures trial compliance. By utilizing a centralized data management system that proactively identifies potential issues the moment they arise and delivers study data quality and integrity from start to finish, medical monitors can work with greater confidence and control.

Centralize and Simplify Medical Review with eClinical

With a centralized modern data and analytics platform, you know your data is consolidated, your work is traceable, and your reviews ensure protocol compliance and patient safety. A single source of truth for data analysis and reporting not only results in higher-quality submission-ready data but also automates work and enhances your ability to comply with your high-quality review processes without negatively impacting timelines.

To streamline and simplify your medical review processes, embrace the future-forward clinical data and analytics platform that does the heavy lifting for you.

The elluminate^® clinical data cloud has helped life sciences companies seamlessly integrate and unify all their data sources – including EDC, eCOA, and labs – for streamlined data review, exploration, and new data insights.

Watch this short overview video to learn how Medical Monitors utilize elluminate to empower their medical review and oversight.

If you want to learn how the elluminate Clinical Data Cloud empowers medical monitoring teams with centralized access to real-time data & improved medical review capabilities, watch our most recent webinar.

Authors

Donna Lacroix

Senior Clinical Data Reviewer, eClinical Solutions

Donna Lacroix is a Senior Clinical Data Reviewer with eClinical Solutions. She works with a team of Clinical Data Reviewers, who are responsible for performing scientific data review of subject level patient data via data visualizations, and other reporting tools to ensure medical plausibility, adherence to protocol and to ensure overall data quality and safety. She is an Oncology Certified Nurse, (OCNZ^©) with > 35 years of clinical experience at UMass Memorial Medical Center, and most recently Dana Farber Cancer Institute in Boston. She has clinical expertise in the fields of pediatric and adult oncology, hematology/oncology, bone marrow transplant and clinical trials.

Karen Skuba

Principal Implementation Consultant, eClinical Solutions

Karen is currently a Principal Implementation Consultant for eClinical Solution’s elluminate Clinical Data Cloud. She enjoys working with clients throughout the implementation process, and especially likes to get crazy with a pencil and paper to spec out custom reports for unique datatypes. She’s spent much of her working life in big pharma starting out in statistics, moving into the IRT world, and subsequently Data Management/Reporting and Analytics. She now enjoys working with the very dynamic and energetic team at eClinical Solutions, giving clients new pathways into their data.