Dive Brief:
- Six contract research organizations have teamed up to form a collaborative group, dubbed Align Clinical CRO, in an effort to improve clinical trial performance and collaboration with drugmakers.
- The founding members include: Syneos Health Inc., PRA Health Sciences Inc., ICON plc, Medpace Inc., Pharmaceutical Product Development LLC, PRA Health Sciences Inc. and United BioSource Corp. Together, they aim to jointly "develop open technology standards to transform clinical trial operations across the entire industry to speed product development."
- To start, Align plans to create a data exchange standard to help streamline how information is shared between trial sponsors and CROs.
Dive Insight:
The contract research and manufacturing sector has seen higher utilization in recent years as large pharma shift more toward outsourcing clinical trials and drug production. According to Credit Suisse research cited by Align, 50% of clinical development management will be outsourced by 2020.
But big pharmas aren't the only ones relying on CROs to do this important work — biotechs also can find these third parties to be cost-saving resources. Yet, for smaller companies, working with CDMOs can be increasingly challenging.
"This is my fourth biopharmaceutical development company that I've run as a CEO, and in almost every instance the CROs ... they give you little attention," Marty Driscoll, CEO of Spring Bank Pharmaceuticals Inc., told BioPharma Dive during a panel at the J.P. Morgan Healthcare Conference in January.
"We get much less attention than the large pharmas where they have preferred arrangements and the bulk of the revenue is generated in those organizations," he added.
Compounding matters is the tremendous upheaval and consolidation within the contract services space that has seen CROs and CDMOs become even larger. These new giants can offer greater reach and economies of scale, but smaller clients may get lost in the shuffle.
Banding together to create common standards could help improve collaboration between sponsors and CROs for pharmas and biotech alike.
"By creating a vehicle for CROs to collaborate and share actionable insight with sponsors, we can improve operational delivery and streamline the increasingly complex trial process," said Rachel Stahler, CIO at Syneos Health, in a statement.
Align expects to post its data exchange standard for public review and input sometime later in 2018.