A Shifting Paradigm in Biotechnology

Electronic Data Capture and Clinical Trial Management are undergoing significant changes. Those changes are being driven by technologies such as Clinical Studio. Companies are shifting from obsolete technologies that require an army of IT professionals to modern, state of the art and cost-effective technologies that require no IT professionals. The two main factors in this change are superior technology and significant cost savings, which almost always go hand-in-hand.

The days are numbered for companies that cannot compete on a technology or cost basis. In fact, these companies provide all sorts of services that traditionally are provided by Clinical Research Organizations (CROs). The biggest reason these companies provide these services (study builds, SAS programming, monitoring, medical coding, etc.), is that you need to have a computer science degree just to use these “features”. This phenomenon morphed technology companies into CROs. Oftentimes, CROs use these “technology companies”, thus funding their own competition.

Technologies like Clinical Studio allow biotech companies to bring outsourced services in house. Clinical Studio allows clinical research professionals to rapidly build and deploy studies. This is giving biotech companies tremendous control over their studies. The results are much more favorable than the outsource and the cost savings are significant. How is this possible? Technology, or put another way, superior technology. If you can write a document in Word, you can build a CRF in Clinical Studio, write a report, deploy ePRO forms to patient’s mobile phones, manage inventory, or even auto-code medications and adverse events.

Beware to the CROs that are so comfortable with their success that they have no experience utilizing the modern tools of Clinical Studio to conduct studies. This biotech industry shift from offshore outsource to internal study management is spreading fast. These companies will inevitably need CROs to quickly build, deploy, and manage studies. The cost savings are so significant, these companies can now conduct double the studies for the same price. The technology is so significant, that study durations are now being cut by a whopping 50 percent through platforms like Clinical Studio.

In 1980, the CP/M operating system scoffed at the growth rate of a little known OS called MS-DOS. Within 2 years, MS-DOS completed dominated the business landscape and had a near monopoly. Those companies that stayed on the CP/M platform are no longer around (do you use Word or Word Star?). Technology changes quickly, and it is the quick thinkers that have the staying power.