Simple, Fast, Affordable: An EDC Built for Your Clinical Trial Needs
Clinical trials are the building blocks of modern healthcare. The eczema ointment within reach in your bathroom cabinet, the antiretrovirals that allow people with HIV to live long and healthy lives, and the various treatments giving hope to patients across the globe—these are all the result of careful testing to make sure they’re safe and effective.
Trials consist of many stakeholders and moving parts: the sponsors spearheading research into new treatments, the sites that execute complex and rigorously controlled studies, and the patients who volunteer to help build a healthier world for everyone.
The raw output of these studies is data. Mountains of data.
This includes patients’ medical backgrounds, how they responded to different doses, and how the treatments made them feel. Within this info are the answers that researchers are looking for: drugs and devices that give the desired results, areas of risk that must be limited, and countless variables that affect how and for whom treatment is most effective.
The process by which data is captured, managed, and interpreted is therefore a fundamental aspect of all clinical trials. How we make use of this data can literally impact the health outcomes for millions of patients worldwide.
Solving the Data Challenge
For a long time, clinical trial data was captured on paper. Site staff would write down their notes, transcribe them onto forms, and send duplicates to the sponsor where the information would be transferred manually into databases. Not only was this time consuming and labor intensive, but it was easy to make mistakes, and often difficult to identify and correct them.
Electronic data capture (EDC) was a turning point for clinical trials. Introduced in the 1990s, EDC software enables the collection, management, and storage of digital data, such as:
- Participant demographics
- Medical histories (like previous illnesses or surgeries)
- Lab results and physical assessments
- Side effects and adverse events
- Patient-reported outcomes (like quality of life or pain levels)
By inputting information directly into a centralized system, it streamlines and automates many of those formerly manual, paper-based processes.
As EDC has evolved, the volume and variety of data that can be captured and analyzed has grown exponentially (at an unprecedented rate), incorporating, for example, info gathered by increasingly advanced medical sensors.
EDC has fundamentally changed the scale on which trials can operate, while boosting accuracy and safety to make sure new treatments meet the stringent standards placed on them by regulators.
The Right Tool for the Right Job
Launched in 1999, Medidata’s Rave EDC draws on its experience of serving more than 1.8 million users across 36,000+ studies to continually refine what the platform can do and how it can make the work of researchers easier—while putting deeper insights at their fingertips.
Rave EDC supports studies where tens of thousands of patients are enrolled across multiple sites. It offers extremely granular control over the flow of data and how the study is configured and customized, so that complex trials on a vast scale can be executed effectively.
Put simply, Rave EDC is the engine that drives the data and outcomes for clinical trials.
But not all trials require that level of complexity. For a smaller scale study—one that perhaps has fewer resources behind it—researchers may find themselves overwhelmed by the options offered by such a comprehensive EDC platform.
“The budget for simpler studies can be somewhat small. That's obviously a challenge, if the cost of the technology exceeds what your budget can bear.”
— Wayne Walker, SVP, Rave Platform Technology
The most elaborate tool isn’t the most suitable in every situation. A power drill with multiple attachments and settings is extremely useful in many circumstances, but it’s not much help when you want to push a thumbtack into a wall. Researchers can end up paying for advanced EDC features that they don’t need, spending unnecessary budgets that could be used elsewhere.
Rave EDC does it all, but you don’t always need “all”, making various features and capabilities a budget-drain without adding value. In some cases, a more refined and streamlined solution is called for.
That solution is Rave Lite. Tailored for use in Phase I trials (early-stage drug testing in small groups), Phase IV trials (where treatments continue to be monitored after approval), and medical device feasibility studies, Rave Lite is a focused offering of Rave EDC’s trusted platform.
It delivers exactly what these smaller studies need without additional bells and whistles that they won’t use.
“It's not a matter of what we’re taking away from Rave EDC, but actually right-sizing it for these simple studies.”
— Nicole Montgomery, Sr. Director, Product Marketing
Users familiar with Rave EDC will be immediately comfortable with Rave Lite’s interface, while new users leveraging Rave Lite will easily be able to switch to Rave EDC at a later date if needed. They stand to benefit from cutting up to one month off the median build time, and up to five months off the overall study process when combined with Medidata’s other tools and services.
Importantly, Rave Lite delivers a streamlined platform without ever compromising on the power and reliability of Rave EDC, so users can be confident that the needs of their study will meet the highest standards. “It's the same EDC you already know and use, just with a simplified study build,” says Nicole Montgomery, Sr. Director, Product Marketing, Medidata.
“We don’t believe that you need to compromise on user experience for affordability… Rave Lite is cost-effective and offers the full Rave EDC experience for phase I, phase IV, and medical device studies.”
— Wayne Walker
Our simplified, cost-effective solution makes it easier to get trials off the ground and reduces the pressure on sites. And it’s not just clinical professionals that benefit. Ultimately, we’re working together to get safer, more effective treatments into the hands of people like you, faster.
Learn more and see if Rave Lite is right for your study.
References:
- Analysis of difference in median build time vs. matched studies not using PS (p<0.05);Reduction of 30 days
- Analysis of difference in median FPI to LPLV time for EDC + at least one additional product vs. EDC only studies (p<0.05).
- Analysis of difference in median LPLV to DBL time for EDC + at least one additional product vs. EDC only studies
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