Biopharmaceutical sponsors outsourcing clinical research services must wade through a bog of incomplete information, and outright misinformation, when seeking reliable partnerships. For the most part, sponsors must rely on word of mouth and previous experiences with vendors to guide decision-making — a scenario in which inadvertently overlooking elements of the partnership can be damaging to both clinical outcomes and the brand’s reputation.
While all biopharma organizations are likely to share common product development goals — risk minimization, adhering to project timelines, controlling costs, etc. — the optimal path to achieve those goals (and the optimal partner) differs based on a number of factors, including the product type and the market. Vital steps in the partner-vetting process include understanding the dynamics between biopharma organizations and contract research organizations (CROs) of different sizes, as well as dispelling some misconceptions surrounding CROs.
For example, it often is assumed that large CROs maintain a vast resource pool and employ a subset of amazingly talented people. While this belief is accurate in many cases, the assumption those resources and talent will be assigned to your project — and remain assigned to your project for its duration — is flawed. “The Great Talent Misconception With Large CROs” (page 05) examines how a shift from client/site/patient centricity to one of profitability and return on investment (ROI) has driven an exodus of talented people from large CROs. The article also explores how a combination of complacency, non-merit-based compensation, abysmal recruiting practices, and more prevents those large CROs from attracting comparable replacement talent.
Sticking with large-vs.-small CROs, this eBook’s second article, “Is There Really Less Risk In Selecting A Large CRO?” (page 07) scrutinizes a series of risk factors associated with partnering with a large CRO. The article then looks at potential risk-aversion benefits of partnering with a more moderately sized clinical research partner.
Third, “Get Who You Want, Not Who They Have: Why Multitherapeutic Resources Aren’t Always The Answer” (page 10) probes whether a purpose-fit tool (i.e., a smaller CRO focused on particular therapy areas) is likely to yield more precise or cost-effective results than a Swiss Army Knife.
Next, “The Fallacy Of The Corporate Memory Concept” (page 12) deconstructs the claim that traditional CRO partners can apply extensive expertise or experience to your development project because they’ve already executed similar projects. Pulling back the curtain on this notion of “corporate memory” often reveals inefficiencies caused by “that’s the way it’s always been done” thinking.
Finally, “Do You Take Comfort In Governance Agreements?” (page 14) shines a spotlight on whether governance agreements actually reduce a biopharma sponsor’s vulnerability, or whether the project control and accountability those documents guarantee is an illusion.