I have long argued that clinical development has been moving in the direction of comprehensive eClinical solutions that enable transparent sharing of data and more efficient production of information. The recent acquisition of Phase Forward by Oracle is a significant milestone in the shift towards that goal. In discussion with numerous trial sponsors regarding their selection of particular eClinical applications (e.g. EDC, CDMS, CTMS, IVRS, ePRO, Drug Safety, etc.), there has been only fleeting
Our assessment of the EDC market suggests that this specific major eClinical market segment is beginning to saturate and will reach full penetration over the next few years, especially for large Phase III trials. Phase II trial saturation is not far behind, leaving growth in Phase I and Phase IV as the remaining opportunities for significant growth. Based on our separate view of the changing drug development industrial ecosystem, we separately anticipate that the industry is shifting bimodally to a small number of mega-pharmaceutical companies and a large number of small biotech companies. With both Oracle's and Phase Forward's historical strength in large pharma projects, opportunity continues to lie with addressing the growing small biotech space. Phase Forward's SaaS offering promises to present potential opportunity in this space as well, but that remains to be seen.
Among the clear underlying complications for Oracle remain sponsor requirements for "best of breed" solutions in each space and the tendency for sponsors to customize whatever product solution they have chosen to address their own specific study requirements. There tend not to be single "best of breed" solutions for each eClinical category (e.g. Medidata's Rave Capture as a leading EDC solution along with Phase Forward's InForm). All vendors openly empower interconnectivity as a matter of practical survival and standards allow reasonably easy connections, supported by both the vendors themselves as well as from numerous SI services companies. Companies tend to move slowing away from current entrenched legacy solutions, in part due to lethargy, but also due to the cost, time, and risk associated with moving to a new platform.
Successful eClinical vendors need to work more diligently than ever to differentiate themselves in the marketplace. An additional shift in market dynamics is the move towards clinical trial outsourcing. With a growing role for CROs in clinical trials, vendors need to strengthen their relationships with CROs to provide alternative options (often bundled) that can be selected by project sponsors. Strong individual eClinical segment strengths can be highlighted and brought together with other leading solutions (either along with or separate from Oracle/Phase Forward components), enabling continued vendor growth. Separate from CROs, some project sponsors can be expected to continue to use and expand individual vendor offerings within their organizations, allowing for incremental growth for the foreseeable future.
It is clear that the Oracle acquisition of Phase Forward strengthens their argument that they can offer a viable, comprehensive eClinical solution to project sponsors. That said, other vendors will need to be prepared to effectively differentiate themselves in the market to survive and succeed. The industry overall is in transition and winners will be those companies that are able to defend and grow their markets in concert with ongoing changes.
As always, alternate opinions and comments are welcomed.