Outsourcing methodologies between large pharmaceutical companies and clinical research organisations (CROs) has rapidly evolved across the healthcare and clinical research landscape.
The outsourcing spectrum has evolved beyond full-service outsourcing (FSO) and functional service provision (FSP) to include blended and hybrid models, which are progressively more common.
Sponsors seek tailored solutions and custom models to fit their unique needs on ever more complex trials and CROs are shifting to a more consultative dynamic backed by their deep banks of best practices.
These novel methodologies are increasingly driven by an imperative for partnership that, in turn, has enhanced the role of partnership culture to support, inform and maintain operational decision-making.
As collaboration intensifies, alignment in partnership culture and strategy becomes a key component for effective outsourcing.
Strategic partnership
Sponsors’ increasing interest in strategic partnerships reflects their desire to engage more collaboratively in the development process while maintaining strategic control.
Revenue loss from patent expiration on blockbusters between 2020-2026* together with macro-economic pressures – inflation and debt servicing, AI transformation of drug discovery and acceleration of drug development etc – are forcing sponsors to review core competencies, operating models and cost structures.
With these compounding pressures, sponsors are seeking trusted partners that can help them navigate complex challenges, identify creative solutions, foster innovation and create efficiencies that can facilitate delivering more clinical trials for the same R&D spend.
CROs are expanding their services to offer strategic advantages as partners, becoming the incubators and testers for innovation in decentralised clinical trials, big data and artificial intelligence.
The consolidation in the CRO landscape and continuous acquisition of new capabilities provides access to specialised expertise, cutting-edge technology and global patient networks, allowing pharmaceutical partners to focus on the science.
Change managers
As complexity increases within the industry – within trials and outsourcing methods – trusted partnership and cultural alignment are vital to success.
Developing this alignment requires deeper awareness of the complexity, requirements and positioning of the relationship and more transparent governance structures designed to support closer collaboration.
This enables partnerships to set clear expectations around shared goals and responsibilities to deliver trials more efficiently.
CROs are often assuming the role of change managers and leading the alignment initiative between organisations. Successful alignment, however, requires an investment of time, energy and resources from the highest levels across both organisations.
Understanding requirements of the partnership will help to guide and optimise this strategic investment of resources, strengthen trust and mutual respect, and ultimately drive success in drug development programmes.
Alignment as antidote
Clinical research now requires a more comprehensive, strategy-driven delivery with seamlessly integrated end-to-end solutions. Cultural and organisational alignment is a crucial operational support amidst this complexity.
Investing in formal governance and alignment frameworks to measure performance metrics, assess shared objectives and KPIs facilitates harmonised operations. Carefully selected partnership metrics can gauge progress and support mutual success.
These controls can flex to be as granular as needed to match the inherent complexity of the partnership and desired outcomes.
As CROs refine these models with lessons learned from one partnership to another, they are piloting new methods and solutions to drive efficiencies within the increasingly complex research landscape.*33 of the biggest selling therapies expire within next six years, e.g. 2023 – market exclusivity for Humira ($17.3bn), Januvia/Janumet ($1.8bn) and Stelara ($6bn) expires (figures 2021 US revenues).
Jeff James is Executive Vice President, Alliance Management at ICON. He oversees the company’s partnership strategy and management of ICON’s largest customer relationships. Jeff has over 20 years of experience in clinical operations, project management, and alliance management, having worked in large pharmaceutical and biotech companies and CROs.
