Integrating EDC and RTSM Solutions

To accurately randomize and dispense inventory, there are critical data points a randomization and trial supply management (RTSM) solution must capture, for example, data required for stratification or dosing decisions. These same data points also need to be captured in the subject’s casebook via an EDC solution.

Without integration between RTSM and EDC, site users duplicate this data entry, creating additional workload and potential for error. Teams reviewing the data also have duplicated efforts for data review and reconciliation.

Integrating RTSM and EDC is not a new concept by any means; it is common practice. But historically, legacy solutions with legacy integrations have faced challenges such as integration failures, labor-intensive build processes, and difficulties changing data.

Let’s review the benefits and limitations of two different integration approaches: embedding RTSM features directly into the eCRF and connecting stand-alone solutions.

An “embedded” strategy

An embedded approach combines EDC and RTSM functionality in one tool, for example, allowing randomization and dispensation transactions to take place from within the subject CRF. A single place to enter the EDC and RTSM patient data can be convenient for site end users. However, there are some compromises to be considered.

By tightly binding this functionality together, there are impacts on both usability and product development. For example, the MHRA guidelines emphasize that the Investigator should wholly own the CRF. Therefore, performing some RTSM transactions within the CRF can become problematic if sponsors wish to build in important approval processes (e.g., additional eligibility checks) or if more complex data changes are required.

The CRF itself is limited to what types of transactions it can control. While patient transactions are a good fit, other critical RTSM transactions relating to inventory, such as shipment/IP management, are still external to the CRF. With so much emphasis placed on the CRF design, the intricate challenges of supply management are at risk of being an afterthought.

Modern systems must keep pace with modern trial design and science. Building large multi-functional systems with interdependencies can slow down the ability to innovate with new features and quickly pivot if needed.

A “connected” strategy

In a connected approach, EDC and RTSM are separate stand-alone solutions. Sites perform time-sensitive transactions within RTSM, such as randomization, dispensing, and IP management, and complete further data capture within the EDC. Historically, using traditional systems and legacy integrations, this approach has resulted in integration failures and lengthy set-up timelines. However, through purpose-built APIs and improved workflows for exceptions (such as managing frozen/locked data), modern systems can alleviate these past challenges.

Veeva has adopted a connected product strategy. Veeva Vault EDC, a core component of Veeva Vault CDMS, provides an easy-to-use, adaptable, and more streamlined way to capture data than traditional EDC vendors. Veeva RTSM provides fast, intuitive, and complete randomization and trial supply management capabilities. By connecting these solutions and defining which system is the source of truth, you can integrate data seamlessly to prevent unnecessary duplicate data entry and reconciliation efforts.

There are other important benefits to consider:

• The modern capabilities of Vault EDC and Veeva RTSM allow highly complex study designs to be achieved without forcing either data management or supply management to compromise functionality.
• End users benefit from modern CRF design features; autosave and dynamic behaviors are harmonious with data integrated from Veeva RTSM
• Native functionality of both solutions ensures that mid-study amendments are completed without migrations and unnecessary downtime
• The CRF remains wholly Investigator owned. Supporting workflows can be achieved via appropriate RTSM transactions, e.g., authorization codes for randomization approval.
• While tightly connected, the two solutions have separate development paths allowing for fast innovation
• There are benefits to working with EDC and RTSM via a single vendor; however, Sponsors and CROs still have flexibility and choice; Veeva RTSM does not rely on Vault EDC nor Vault EDC on Veeva RTSM

Importantly, for the site users, any perceived inconvenience for sites can be overcome through modern aligned user interfaces and intuitive navigation workflows.

Conclusion

An embedded approach can be appealing by offering some efficiencies to sites. Yet the reality is there are additional steps for users to take elsewhere, interdependent systems cause limitations in design, innovation is stifled, and customers have less flexibility and choice. However, even embedded approaches don’t remove the additional steps that happen outside the system. Interdependent systems will limit study designs. Innovation is stifled, and customers are given less flexibility and choice in how they conduct their studies.

By delivering connected EDC and RTSM applications, Veeva can meet all the competing priorities of sites, data managers, supply managers, study managers, and statisticians. Modern architecture can provide a better-connected experience than previously possible and allows both solutions to innovate with speed, driving each other forwards rather than holding each other back. This same strategy extends beyond EDC and RTSM, with further benefits to be reaped from connecting both applications across the full Veeva Vault Clinical suite.

Learn more about integrating your EDC and RTSM solutions.