The Future of Electronic Data Capture and Clinical Data Management: Flexible, Scalable, & Unified

The world of clinical data management continues to expand and increase in complexity. As companies race to harness the power of data to improve their clinical trials, this already vast amount of clinical trial data keeps growing. Wearables, sensors, imaging, labs, and remote patient care are just some of the sources contributing to this increase in data. And such a change brings new obstacles for clinical data management teams.

Today’s Clinical Data Management Challenges

Today’s clinical data managers face three main challenges. First, clinical trial data is captured and siloed in multiple systems. This lack of a unified view requires a major effort to reconcile data. Second, data pours in from different sources, rendering the traditional “one-size-fits-all” approach to data collection obsolete. And third, the high volume and velocity of data has exceeded the capabilities of traditional data management systems; these older processes simply no longer scale in this new landscape.

Such challenges underscore the need for an electronic data capture (EDC) system that is flexible, scalable, and unified. Medidata is a pioneer in EDC with experience gained in over 24,000 studies. We understand the opportunities and requirements of the evolving clinical data management space. Below are some key questions to consider when evaluating your EDC system and clinical data management strategy.

Does Your Electronic Data Capture System Provide Enough Flexibility?

At least one study protocol amendment occurs in over half of all clinical trials, according to Tufts Center for the Study of Drug Development (Tufts CSDD) research.¹ These amendments disrupt site users’ workflows, create logistical hurdles for study teams, and cost significant amounts of time. Given the tendency for clinical trials to change, EDC systems need the flexibility to adapt to mid-study changes.

Today’s clinical trial designs are more complex and adaptive than ever. Different forms of clinical trials, including basket, umbrella, and platform trials, require a flexible EDC system to adapt to protocol amendments and other mid-stream changes. Learn how Medidata’s Rave EDC meets these needs so you can adjust seamlessly without downtime.

Is Your EDC System Future-Proof?

Clinical trial sponsors and CROs are moving toward decentralized clinical trial (DCT) models with increasing frequency. More clinical trial data is coming directly from patients through sensors, smartphones, and tablets and less from eCRFs. This shift in data acquisition started with the COVID-19 pandemic and has now become the new data normal.

As the volume, velocity, and variety of data continue to expand, sponsors and CROs must reevaluate their EDC platforms and ask: is our EDC up to the task? Here’s how to know if your provider is innovating with the pace of the industry.

Is Your EDC System a “One-Size-Fits-All” Platform?

Pharma/biopharma companies conduct a wide range of clinical trials: single-site rare disease trials, highly customized precision oncology trials, midsized Phase 2 studies, and large, global infectious disease trials. But many EDC systems lack the functionality to accommodate more complex clinical trials; this means sponsors must switch to another platform or integrate additional electronic data capture technology to run such studies.

Inflexible EDCs create a host of problems for sponsors and CROs. You need a reliable EDC system that scales up or down as necessary when running a wide range of studies. Discover how Rave EDC is the one-size-fits-all system of choice across the industry.

Why Build an EDC System on a Unified Platform?

Interoperability within healthcare systems has received considerable attention over the past several years. Interoperability across clinical technology is similarly important for running efficient, patient-centric clinical trials. Clinical technology platforms that don’t integrate with one another cause sponsors and CROs to use separate vendors for different systems; this leads to a loss of efficiency as clinical trial data is instead siloed in disparate systems that don’t share information.

A unified platform approach brings together multiple clinical research capabilities to solve many usability challenges facing clinical research today. See how operating on a unified platform combines data from multiple sources with single sign-on capabilities for an easy-to-navigate experience.

What Are the Challenges to Faster Database Lock in Clinical Trials?

Patients, sites, and sponsors each perform activities within a clinical trial. Conducting these activities on a unified platform can remove bottlenecks that stall the clinical trial process. Many workflow problems and challenges exist within clinical research that slow down the path to a faster clinical trial database lock.

Data entry, data aggregation, data cleaning, source data verification (SDV), and data transformation each produce their own hurdles that must be addressed throughout the clinical data management journey to craft intelligent processes. Learn how cloud-based platforms, like Rave EDC, streamline workflows to lower development costs, limit risk, and get drugs to regulatory approval faster.

How Does Medidata Rave EDC Improve the Clinical Trial Site User Experience?

Clinical trial data management faces multiple difficulties no matter how well-designed or properly executed. Redundant data entry, lack of interoperability between systems, and design inconsistencies are common hurdles that affect clinical trial data collection.

There are multiple ways to improve the EDC user experience, including obtaining input from stakeholders and using an EDC that adapts to mid-study changes and easily integrates with other technologies. Here’s how Rave EDC is designed for clinical site users to succeed.

Get Started With Next-Generation Clinical Data Management Solutions

Next-generation clinical data management requires a shift from manual tasks of the past to automated, proactive insights. Medidata transforms clinical data management processes through data integration, standardization, and advanced analytics. These solutions let sponsors and CROs deliver high-quality clinical trial data faster to accelerate clinical trial results and get treatments into the hands of patients.

Contact us today to learn more about our scalable clinical data management solutions.

¹ Getz KA, Stergiopoulos S, Short M, et al. The Impact of Protocol Amendments on Clinical Trial Performance and Cost. Therapeutic Innovation & Regulatory Science. 2016;50(4):436-441. doi:10.1177/2168479016632271