"Change is the only constant in life.” That quote is attributed to Greek philosopher Heraclitus, but its theme still resonates today in many areas, including pharma. When it comes to clinical outsourcing, it certainly seems like the only thing that doesn’t change is change.
Last year when I prepared this annual CRO Supplement, our cover story featured Corsee Sanders of Roche. While most of the article centered on combining analytics with clinical operations, Sanders did note another major change underway at the company: Roche would focus on managing late-stage studies within the company, with few exceptions. Only site monitoring would be outsourced.
Certainly some promises related to strategic outsourcing have thus far failed to come to fruition. One article in this issue from The Avoca Group focuses on sponsor survey results and notes several areas of dissatisfaction. But if you thought the era of outsourcing to strategic partners might be coming to an end, think again. In this issue you will read about the efforts of two companies, Takeda and EMD Serono, that each opted to form a strategic agreement with one CRO. All clinical trials will now be conducted by that single CRO partner.
Some in the industry think strategic partnering is still a dream of only large pharma companies. But as you’ll learn in this issue, 62 percent of sponsors now consider themselves to be in a strategic partnership, an increase of 27 percent over 2011. Yet many small to midsized companies will still tell you they are not large enough to even consider having that type of relationship with one CRO. They continue to try to make some form of the functional service provider model work for them. In fact, despite the rise in strategic partnerships, 79 percent of sponsors still tout working with four or more CRO partners.
No model of outsourcing is perfect, and every variation of it will come with strengths and weaknesses that sponsors will be forced to navigate. The pros, including more timely, efficient, and cost-effective trials, are enticing. But the cons, including lack of cost savings, staff changes, and providing proper oversight, will continue to keep operations personnel awake at night. Among sponsors, there has been a double-digit decline in satisfaction with access to high-quality personnel. Furthermore, the number of sponsors noting their goals for cost savings are being met dropped from 48 percent in 2011 to 45 percent in 2016.
Is there a solution? One new alliance comprised of service providers thinks there is. The consortium, composed of five service providers including inSeption Group, FMD K&L, and Pyxa Solutions, believes the solution starts with leveraging the strengths of each member organization across all functional areas of R&D. The promise is knowledgeable personnel, a seamless integration with one point of contact, and greater transparency over trials. Will this new model work? That remains to be seen.
One thing is clear — challenges to outsourcing remain, and sponsors will continue to work at becoming fully operationalized with their partners. Change will remain an integral component of every outsourcing relationship, and we hope to see the day when all of the promises of strategic partnering come to fruition. In the meantime, Heraclitus would be proud to know his words continue to bear on the clinical world.