What Should be Considered When Selecting an RTSM Vendor?

Whether you are selecting a vendor for a single clinical trial, a program of clinical trials, or becoming an enabled build partner, it’s imperative to select the right technology and partner. The technology must support your business as it grows, and your partner must be committed to your success.

RTSM is not yet a mature software space

In a mature market, customers focus is on costs rather than benefits. This is not the case today in the RTSM software market. The service provided today by software vendors varies widely, with conveyed benefits varying greatly. Consolidation has yet to occur, as commoditization of systems and capabilities is realized. With a maturing market, we would expect to see a move from customization and services-led companies to more configurable platforms that increasingly rely on technology, than services, to ensure customer success.

Against this backdrop, it’s important for customers to choose the right partner, whether it’s a tactical decision for a single clinical trial now or a strategic decision for future studies.

Factors to consider in selecting an RTSM vendor

• Vendor experience—how long has the vendor been providing RTSM services? It’s critical that your RTSM vendor shows longevity in the marketplace.
• Technology investment—most RTSM vendors invest in services over technology and the result is they cannot scale their business. Without a significant investment in hosting, IaaS, PaaS, and the user interface vendors cannot scale because they can’t hire enough project managers, developers, and testers to support new study builds and mid-study amendments:
  • Zero downtime system upgrades. Required if your study may last 5+ years.
  • Zero downtime mid-study amendments. The average study has 5 amendments.
  • Roll-out amendments by site.
  • Powerful visualization engine, not customized reporting.
  • Standards libraries to streamline deliver.
  • Scale to support growth of studies.
  • Scalability—as you support more studies you should not require more PMs, developers, and testers. Technology drives efficiencies and allows your business to scale.
• Quality and risk—what drives risk? Customization in an RTSM system should be considered a bug, not a feature. A mature RTSM tool will support a wide variety of clinical trial protocols and drug supply management scenarios. Technology that requires customization introduces risk to your business, drives additional validation during study builds, requires extensive regression testing, and drives total cost of ownership (TCO).

Takeaway

As the RTSM space matures, many vendors will struggle to survive as price competition heats up and profit margins shrink. Vendors with configurable, scalable technology will win and those vendors reliant on services will struggle. Vendors that are able to offer traditional RTSM capabilities within clinical trial platforms will have the added advantage of providing customers with additional synergies without the need for expensive and timely integration projects.

Learn more about Clinical One Randomization and Supplies Management.

Explore Oracle Life Sciences to learn you you can accelerate your clinical trials.