More Trials, More Collaboration: Pharma and Biotechs Rely Heavily on CROs
Pharmaceutical companies of all sizes have no time to waste in organizing and executing phase 1 and 3 clinical trials. To create efficiencies and accelerate development, companies are increasingly outsourcing clinical trial design and execution to contract research organizations (CROs).
“We’re having a resurgence [in CRO activity] right now,” said Jan Twombly, CSAP, president of The Rhythm of Business.
CROs have the resources and expertise—both around running trials in general and in specific therapeutic areas—to hit the ground running, which many times makes them a faster and more efficient alternative to conducting trials in-house for pharmaceutical organizations.
Predictably, the Covid-19 pandemic has wrought changes, good and bad, to the preclinical and clinical phases of the drug discovery cycle and the path forward for pharmaceutical companies and CROs.
“There are challenges around health resources across the industry,” said Holger Liebig, executive director of large CRO Parexel’s Partnership Center of Excellence, during the opening remarks of his 2022 ASAP European Alliance Summit presentation delivered last fall in Amsterdam. Liebig added that “there is a particular demand for nurses and skilled staff members. They are core to the success of our trials.”
Global supply chain disruptions have made it hard to get basic supplies, such as syringes. However, the acceleration of telemedicine has enabled the industry to conduct “decentralized clinical trials,” in which technology is used to monitor participating patients at their homes and receive relevant data remotely, according to Liebig.
The Path to Large-Scale Consulting
Although CROs have existed since the 1940s, their role as strategic partners has expanded in recent years. Large CROs like Parexel, Covance, and Quintiles were formed in the 1970s as regulatory frameworks were unfolding, and in the ’80s and ’90s as clinical trial costs continued to soar, CROs were sought after to create efficiencies and maximize value. Still, the relationship between CRO and client was still very tactical.
But in the early 2000s, CROs began to go global, and over the first decade of the millennium more CRO–Big Pharma relationships evolved into true partnerships. Moreover, CROs’ customer bases began to diversify with the emergence of biotech companies that started outsourcing their clinical trials as well.
“As strategic partners, CROs offer more specialized expertise and a collaborative and tailored approach that addresses the specific clinical, regulatory, and commercialization needs of clients,” said Liebig. “We work together at ‘eye height.’ We look at each other at the same level. We work together and exchange ideas and strategies to innovate successfully.”
Multiple-Tier Governance Models
What type of governance model works for CROs and their clients? Liebig walked attendees through multiple models and their applications.
A two-tier model organizes day-to-day activities by individual study and asset, typically with multiple studies under each asset. The model includes executive and operational governance steering committees and an approach that brings together a team of senior leaders from each organization to evaluate key performance indicators (KPIs) and ensure the long-term success of the business.
“For larger companies, models can be adapted to include other governance committees as applicable,” stated Liebig, before listing regional, technology, therapeutic, quality, functional, and commercial committees as examples of additional governance committees.
For smaller companies and biotech relationships, Liebig said that it’s common to utilize a single Cross-Functional Steering Committee (CFSC) consisting of senior operations managers who meet quarterly to assess aspects that fall under both the executive steering committee’s and operational steering committee’s jurisdictions in the multiple-tier model.
Pro Tips for Better CRO Relationships
Liebig concluded with key recommendations for ensuring a successful partnership:
- Choose the appropriate outsourcing governance model with care and implement it well.
- Share information freely and be transparent. In this process, CROs should gain early feedback on the “Book of Work” detailing the development plans and study protocols. “What are they doing next year? Which trials do they want to start? Where are they going?” said Liebig.
- Create efficiencies by enabling CROs to leverage their systems and processes. “When you use your own processes and systems, you reduce the chance for errors, it’s more integrated, and saves time.”
- Create clear lines of communication and establish roles and responsibilities. To the latter point, Liebig emphasized the need to eliminate the duplication of efforts and build a trusting relationship based on informed decisions to achieve shared milestones.
- Aim for mutual success for both parties, setting expectations early on. “Establish resourcing that sets both parties up for success and can be easily adapted as the partnership grows,” said Liebig.