Industry Standard Research (ISR), a full-service market research provider to the pharma and pharma services industries, has collected information from outsourcing decision makers via an online survey regarding their selection and evaluation of CROs.
"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.
Dr. Azmi Nabulsi will tell you that one of Takeda’s principal beliefs is that it cannot do everything on its own. Therefore, the company strives to achieve excellence in R&D by working with trusted partners. As the deputy CMSO (chief medical and scientific officer) and head of strategic and professional affairs for Takeda, Nabulsi understands that the benefits of those partnerships can manifest themselves in everything the company does, from bringing new compounds into the pipeline to increasing operational efficiencies. The strategic partnership Takeda formed with PRA Health Sciences last year was a major part of that philosophy and the company’s drive toward excellence in clinical trials.
For years, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany used a mixed clinical outsourcing model. The company conducted some trials in-house but outsourced others to external service providers. For trials in development around the world, the company had four global CRO providers. For regional Phase 4 and label expansion studies there were as many as 100 different providers, which included niche CROs from around the world.
As the majority of clinical trials involve external collaborations, healthy relationships between a sponsor and its partners (e.g., CROs) cannot be overemphasized. In this article, much of what we will discuss pertains to the relationship between a CRO and its sponsor, the life science company. However, any company providing a contracted service to a sponsor will find there are valuable lessons to be learned regarding relationship management.
CRO selection is a challenge for every company outsourcing clinical trials. When the trial you are about to launch is for a rare genetic disease and has 30 patients spread across several countries and continents, the challenges are multiplied.
Sponsors and CROs have entered into more and more strategic partnerships during the past decade to achieve a range of shared and distinct goals. Yet, while many of the partnerships were unveiled with media fanfare, there is a shortage of analyses of what both sides want out of relationships, the extent to which their expectations are being met, and what this means for the future of clinical outsourcing. To address this gap, The Avoca Group followed our 2011 survey on strategic partnerships with a new canvassing of sponsors and providers.
Potential partners often take positions during a contract negotiation that at best delay the project, and at worst, scuttle the partnership. Here are three examples of short-term thinking that are common in both the customer and contractor sides of the negotiation.
The mounting public outcry over drug prices — fueled by dramatic increases in cost for a few high-profile, older, life-saving drugs — has put intense pressure on the pharmaceutical industry to lower prices.
Unlike Big Pharma, which may outsource internally developed processes and formulations, small and midsize pharma/biotech firms are dependent on contract development and manufacturing organizations (CDMOs) for much of their product development and GMP manufacturing activity.