So what will the eClinical landscape be like in 2009? Here is a projection on what I believe will transpire in the eClinical business area over the course of the next year. As ever, these are purely my opinions, and do not reflect the opinion of the company I work for...
We have seen significant changes over the preceding 2 years. The number of vendors have shrunk with Medidata and PhaseForward apparently swallowing up the vast majority of new business.
Oracle have been suggesting the availability of a new, improved product. If they want to stand a chance against the big 2, then they are going to have to get the EDC portion right this time. Previous attempts were so far from the mark with regards basic EDC functionality and ease of use that they bombed in the market.
Medidata's announcement of Developer Central is potentially more significant. ClinPage describes this as an API. However, I think that is a simplification that underplays the significance of the release. Back in September, I wrote a blog on Web Services, and how they might impact eClinical.
A number of EDC/CDM vendors have claimed to offer API's - FW-IMPACT and Oracle for example, but many were simply an exposure of a set of Stored Procedures. Techie's developing eClinical systems have talked about a full web service solution for many years. Medidata appear to have take their experiences with CDISC and actually delivered a fully operational solution - a full CDISC compliant Web Service for eClinical data Importing and Exporting.
Google were the first company to really generate buzz around the principle of an API over the Internet with the release of the Google Toolkit. With this, any developer with an Internet connection could send a program request - using web service calls - to Google, and receive search responses that they could use for their own purposes. If the Web Service eClinical API that Medidata has announced is all its potentially cracked up to be, then we should see a long queue of eClinical providers - eDiary, CTMS etc all lining up to be in a position to offer Medidata Rave real-time connectivity out of the box.
On a technical note, it will be interesting to see if the use of the CDASH standards will be utilized as a means to standardize the metadata used to capture the data. If this does occur, we could see a simple handshake occurring at the start-point between the two inter-connected systems to confirm 100% compliance with CDASH. If this is the case, then no manual metadata synchronization need occur. In reality, I suspect ALL CDASH based implementations will be customized, but, its a good start.
Back to 2009 forecasting...
The financial crisis will clearly impact the industry. The smaller companies - BioTech's specifically - will struggle to find cash. If the development programs they are running rely on a constant cash flow, then they could go under. This might provide rich pickings for the big companies looking to pick up a bargain, but, potentially at the cost of new innovations. For the lower end of the eClinical marketplace, things will be tough. eClinical vendors that can demonstrate lowering costs - especially over paper - will see increasing business.
eDiary vendors will continue to see business grow provided they can show interoperability, and, can manage to keep infrastructure costs down. We may see an increase in the prevalence of eDiary solutions based around Off the Shelf or pre-existing hardware - the iPhone for example appears to have the ease of use, connectivity and synchronization capabilities to make it more widely usable then any other OTS product today.
CTMS vendors will increasingly struggle. The value of such solutions is increasingly marginalized with the enhancements offered by leading EDC system providers. Similar to the eDiary space, if they can 'play nicely' with the other systems, they stand a chance. Otherwise, they will be considered unnecessary in the overall eClinical Life Cycle.
Overall, I think we will see the more marginal areas of the eClinical vendor solution business impacted the most. When finances are tight, the argument for these types of systems will be difficult. Life Science companies will focus on cost saving and direct efficiency gain solutions. This will be no time for long term technology prospecting.
For those following these blogs, I wish you well for the holiday period, and Best Wishes for 2009.