Target Health is a double role model. It is showing where both leading technology vendors and fearless contract research organizations (CROs) need to migrate.
As a small, focused, service-oriented CRO, the company knows how to take care of customers ranging from mid-tier biotechs to large pharmas that claim to be standardizing around other technology vendors.
But Target Health is itself a technology company, giving its own software an unusual amount of internal resources and attention. The company takes a release of its core application as seriously as any electronic data capture (EDC) concern. As with much larger EDC innovators, Target Health is exploring both e-source – paperless or almost-paperless data entry – and integration with hospital and physician-office IT systems.
The Manhattan company has just released version 3 of Target e*CRF, a suite of tools for setting up and running clinical trials digitally. The origins of Target e*CRF lie in its own experiences serving sponsors and gathering data. Denmark’s Ferring Pharmaceuticals has already had two NDAs approved with earlier versions of Target’s tools. Ferring says it locks its databases a single day after the last patient visit.
Target Health’s president, Jules Mitchel, is not a fan of software for the sake of software. “Drug development and device development are our business,” says Mitchel. “We make presentations to companies without demonstrating our software. We say, ‘This is what we have done.’ Customers want someone who can help them solve problems, not just make software.” Within e*CRF there is a WYSIWYG editor to create case report forms, and the SAS programming language for edit checks.
The key thing for sponsors, Mitchel says, is that no additional proficiencies will be required by a clinical research associate (CRA) or statistician using the tools. Says Mitchel: “For companies to use our software, they do not need to change the current skill sets employed by the company. The skill sets of a good CRA or SAS programmer are the fundamental skills needed to run our system.”
Mitchel’s VP for business development, Bill Johnson, formerly participated in EDC development at Merck. He believes Target Health is something of a new breed of companies, an e-CRO. Target Health’s technology is sufficiently flexible, Johnson says, to have two different departments in the same company using his software to design trials in their own preferred ways.
Yes, that might seem ill-advised to senior managers in, say, the financial services industry. But in pharma, it’s not top secret that teams dedicated to different diseases or types of trials often have idiosyncratic groups of preferences, standard operating procedures, and even color schemes. All of the above are invariably not shared by colleagues within the same company. Says Johnson of customers: “They can change our system to match their process.”
Joon You, Target Health’s chief technology officer, adds that the system can store the data in any common format. “The system can archive the data natively in XML and also PDF and SAS datasets. It does all three automatically, and there are other formats you can specify like Excel spreadsheets.”