Best EDC systems for clinical trials

Deciding on an EDC system is a high risk decision for sponsors attempting to advance their therapies. The wrong choice can lead to a large loss of investment, both in time, money and potential on a promising therapeutic. The correct EDC system will help a clinical trial run efficiently, raise data quality issues early and surface key insights faster.

With these high stakes, it is crucial to choose the tooling used to run the clinical trial carefully.

Considerations for EDC systems

Electronic Data Capture systems are used to store patient data from a clinical trial. EDC software allows data to be submitted at the point the site or field team first collects it. The data can be in multiple formats, including single recordings, text data submitted by the physician or patient and imaging data. EDC software will usually include a data validation workflow that is followed for each piece of data submitted. Audit trials and some level of data integration features are also considered requirements in EDC software.

Clinical trial design is changing rapidly and the industry’s software vendors are still catching up to the changes. Here are some important and often overlooked considerations in choosing the correct software:

How strong are the collaboration features? Failures in communication between the sites, CROs and sponsors are a frequent source of issues in clinical trials. The strongest EDC’s will have great collaboration features in place to smoothen communication between these groups.

Can this automate significant workflows? Improved automation will allow flagging data quality issues faster, so they can be addressed while it’s still possible. Many minor data quality issues can lead to the disqualification of data from a large number of patients, an expensive outcome.

Is this customizable enough for my trial design? A lack of customization will place limits on the trial design possible and will require a large amount of manual work to generate the reports and analytics desired. The cost to try to manually modify the output to match the trial design will significantly exceed the software’s cost.

Is this modern, usable software? Software that is difficult to use will lead to avoidable errors. Avoid the principal agent problem where you choose software that the users struggle with because you are not required to use the software directly.

Can this integrate with the systems and devices being used in the trial? How will you integrate the EDC with the various data sources being added to the trial design? A lack of a robust solution here will lead to expensive data errors down the line. As hybrid trials incorporating decentralised aspects become more popular, integration of those data sources is essential. This can include patient’s personal devices that are used for data collection, eDiaries and remote patient monitoring. This also includes a larger and more diverse volume of sensor data that comes from advances in medical devices and imaging technology.

Vendor overview

There are many vendors available offering EDC software. Below are a sample of the choices and some of the trade-offs associated with them.

RedCap is a low cost option that can be implemented quickly. Since it was not built specifically for clinical trials though, the feature set is limited. RedCap will require expensive custom or manual work.

Veeva Vault EDC is commonly chosen for its powerful customization for patient forms and data entry. Its data entry has poor usability which can lead to data quality issues at sites. The collaboration features between sites and sponsors are also limited compared to other options.

Medidata Rave is slowly growing into an industry standard among cloud based options. Although the software is well regarded, Medidata struggles to provide enterprise level customer support. This can be particularly painful when attempting to use Rave in non-standard settings or with heavy customization. Rave also has limited integration with non-Medidata products, particularly for remote patient data entry.

Oracle’s solutions (including Clinical and InForm) are strongest in the customization they provide. It is the common choice for complex and large scale multi-site trials. In practice though, it has a poor user interface and significant performance issues. This can result in increased data quality issues that are not obviously tied to the EDC choice.

Clef recommendation

For standard large-scale clinical trials, Clef Consulting often recommends Medidata Rave. The solution is modern, flexible and well regarded by end users. Of course, all trials will have different requirements that may come with different trade-offs. If you are interested in a tailored in-depth recommendation, please submit your email below.

Gaps in existing software

No EDC solution is complete, each choice comes with significant trade-offs. One of the aspects most solutions on the market struggle with is a complete integration with the varied systems and devices being used in a trial. Manual data entry between systems is a frequent source of costly errors. Many trials may have up to thirty different systems from separate vendors.

This is why we built Clef Integrations, a purpose built solution to allow trustworthy data integrations between the systems used in your trial and your EDC. In addition, Clef allows a layer of analytics above the integrations that surfaces potential issues so they can be fixed when still possible. Clef Integrations also includes custom services that allow for integrations with unsupported systems.

Clef can provide additional consulting services from industry experts to guide you through the choice in an EDC system. If you would like to learn more about Clef Integrator or about Clef Consulting Service, please leave your email below.