The ask was to build PRA a faster, more efficient way for their Clinical Research Associates to manage trip reports. The result was better, happier CRAs. (And an $8.5 million savings.)

Building a Better CRA for PRA Health Sciences

Background

We’ve done quite a few projects for PRA Health Sciences, but none as critical as this one. To understand why, let’s talk a little bit about the role of a Clinical Research Associate (CRA).

Before a drug can be prescribed and sold, it has to be proven safe and effective. But getting to that point requires years — often decades of complex, intensely regimented testing, all overseen by the FDA. If a testing site goes out of compliance, the schedule can slip, and millions of dollars can be lost (not to mention the future of the drug itself).

Enter the Clinical Research Associate. CRAs monitor the testing process, ensuring clinics stay in compliance and trials stay on track. They mitigate risk and are critical to the success of any clinical trial.

“BiTE’s senior leadership helped us embrace BDD, define the core strategy and provide critical architecture for our next generation clinical trial platform.”

Jesse O’Gorman
Vice President

Symptoms

When PRA first approached us with this project, they wanted an app that would help CRAs log their travel time and receipts. But at BiTE, we specialize in finding the source of friction and solving real problems for our clients.

We met with dozens of Clinical Research Associates and Clinical Team Managers in the U.S., Europe, and Russia and conducted Jobs-to-be-Done interviews. We asked them what made their jobs difficult and what differentiated a “good” CRA from a “bad” CRA. We studied the processes and protocols of CRAs around the world and read over 30 Standard Operating Procedures (totaling more than 700 pages). All in search of hidden problems we could solve so that CRAs could do their jobs better.

We dove deep.

Treatment

We realized the problem wasn’t just that CRAs needed an easier way to log their hours and track receipts. The real job to be done was building a better Clinical Research Associate. PRA was hiring this product to achieve a competitive advantage by lowering the operating costs of CRAs and speeding drug trials by keeping more sites in compliance.

One of the key goals of our proposed solution was to keep sites in compliance, while bringing those out of compliance back into compliance more quickly, with less risk and at less cost. And each feature we proposed helped reduce waste, allowing associates to work even when out in the field, assign follow-up tasks, securely manage documents, and log communications.

PRA was on board.

If this seems like a lot of preamble before we talk about the product we built, that’s the point. Because developing the right strategy that identifies the jobs CRAs need done and the features required to do them is key to making the products. All before a single line of code is written.

Follow-Up

Using the Jobs-to-be-Done methodology, we learned what really makes a Clinical Research Associate successful and identified obstacles that can limit that success, eat up precious time, and cost money. Every feature we developed in the mobile iOS and Android apps solved real problems for our client.

And speaking of cost, we did a separate study to evaluate the efficacy of our strategy — in hours spent filing papers, logging calls, and creating follow-up instructions, our app is estimated to save PRA $8.5 million per year.

The final product was not what PRA had originally envisioned — it was more. Our solution was exactly what our client needed and wanted. After all, that’s the point of good strategy — to guide you to the best outcome possible.