Biopharma R&D Leadership Agenda | Topic #11 "Clinical CRO Interaction Model"

We engaged our Biopharma clients, external advisors, and BCG's R&D experts to identify the most pressing topics that should be on the agenda of Biopharma R&D Leaders to drive innovation and move the needle on R&D productivity.

We have been posting these topics one by one. Topic #11 is the final one - for now. We look forward to your comments, thoughts, and feedback on Topic #11 and the entire series.

Topic #11 - Clinical CRO Interaction Model:

a) Key Observations

Many CRO customers see CROs struggle to consistently deliver satisfactory results at scale across different geographies and for global studies.

Some of the most severe pain points highlighted by CRO customers, such as patient recruitment, are also among their most important purchasing criteria.

Anecdotal evidence shared by many of our clients supports the empirical observations suggesting that current sponsor-CRO workshare and interaction models are often broken, with both sides broadly dissatisfied.

b) Leader’s Challenge

Over the last decades, Clinical CROs have optimized their delivery models for cost. Most sponsor-CRO relationships are transactional. Many sponsors shifted to FSP models to reduce costs and increase control over quality, e.g., by imposing sponsor systems and SOPs. CRO selection is driven primarily by price and not by best fit with a TA or indication.

With their lower margins today, CROs are even more challenged than sponsors when dealing with complexity and investing in new capabilities.

Sponsors and CROs must work together to fundamentally reengineer their interaction model toward a model in which joint value creation increases and both sides trust and empower the other to do their best work, resulting in more "win-win" scenarios.

c) Actions to Consider (starting list)?

1. Assess the current Development operating model and define the go-forward sourcing strategy (incl. where to pursue hybrid models, what to bring in-house, and what to offshore to achieve cost savings and control)
2. Re-define the CRO-sponsor collaboration model based on aligned interests; implement approaches to enable truly strategic partnerships; conduct value engineering on specific clinical trials for rapid results
3. Jointly with the CRO, optimize shared processes, systems, and workflows, put in place more effective mechanisms for tracking and CRO oversight by the sponsor, and agree on a mutual enablement approach

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We would appreciate your comments, thoughts, and feedback:

• What are your observations on where the industry is headed?
• How significant of a challenge does this topic represent?
• Which other actions should biopharma companies consider?