As emerging biotechs continue to play an increasingly important role in the drug development landscape, their prominence is driving a significant trend in the pharmaceutical industry: a growing reliance on outsourcing in clinical development and beyond.

For a large pharmaceutical company, the decision to work with external collaborators selectively across drug development is usually a strategic move driven by the desire to reduce operational expenses, free up internal resources, and access specialised knowledge where necessary. For emerging biotechs, on the other hand, outsourcing is less of a nice-to-have and more of a fundamental requirement. Unlike more established companies, biotechs lack the extensive in-house capabilities required to develop a drug in-house from start to finish. Their choice to outsource is born from necessity, and the effectiveness of their collaborations is pivotal in the successful development of their molecules.

But when everything is riding on one molecule’s success, outsourcing introduces new pressures and challenges for such companies.

Vendor management challenges

Vendor management involves selecting the right suppliers and service providers, negotiating contracts, managing relationships, and monitoring their performance and regulatory compliance. The more companies a biotech works with as they bring on speciality vendors to support specific areas of clinical development, the more challenging and time-consuming the vendor management process becomes. This administrative burden not only strains internal resources and potentially increases the risk of oversight and regulatory issues, but can also result in inefficiencies, confusion, and duplication of efforts.

Working with a single contract research organisation (CRO) that can provide holistic, comprehensive support enables biotechs to streamline the vendor management process, reducing the risk of misalignments, miscommunications, and missed deadlines. Such a collaboration can set the right foundations for a biotech’s success, particularly when working with the same CRO across an entire program. Program-level outsourcing reduces gaps between phases, simplifies contracting, and eliminates the need for knowledge transfers. A single vendor can better adapt to a drug development sponsor’s needs as the collaboration gains momentum from phase to phase, building on lessons learned at each stage.

Beyond the clinical development cycle, a full-service CRO can support a biotech with regulatory strategy, market access, and HEOR. They can also help start-ups on their fundraising journey, connecting companies with potential investors and helping them prioritise assets and craft value propositions that boost their change of success.

What to look for in a CRO

Choosing to work with a single vendor offers a range of advantages but makes the decision of who to team up with particularly critical in the high-stakes world of emerging biotechs. The most effective collaborators will provide agility and flexibility, enabling them to adapt to shifting needs as the project develops and inevitable hurdles arise.

Crucially, both biotech and CRO must share the same mindset – one that is committed to achieving optimal results and keeping the project moving forward on schedule and within budget. The CRO should treat the biotech’s asset as if it is their own and bring a drug development mindset to all activities, while the biotech should feel the CRO is an extension of its own team.

To this end, risk-sharing models have become increasingly common in the industry, motivating both parties to work towards common goals through financial risks and rewards. This can result in improved outcomes, further incentivising the CRO to prioritise the trial’s success and on-schedule delivery. 

Therapeutic area-specific clinical trial expertise and strong knowledge of regulatory requirements are equally important, helping to ensure well-planned clinical trials that meet the expectations of diverse regulatory environments while minimising trial design risks for cost and time savings.

For emerging biotechs, CRO selection is a pivotal part of the drug development process. To learn more about the trends and challenges within the biotech landscape and the importance of the right collaborations, please download the whitepaper below.