Outsourcing and Operations Takeaways from the OCT NE Conference in Boston
While at the Outsourcing in Clinical Trials New England 2024 (OCT NE), I was able to enjoy time meeting with current and future clients, as well as attending sessions about clinical outsourcing and operations.
These excellent sessions were led by operational leads from biotech and contract research organization (CRO) groups. The presenters spoke about their own experiences in operationalizing clinical trials, sharing success stories as well as areas of recommended improvements to concentrate on going forward.
Clinical trial operational efficiencies
Many of the operational sessions discussed efficiencies in running clinical trials, securing the best talent for the execution of the trials, discussing pros and cons of hiring CROs versus in-sourcing, and best practices in building a successful relationship with your CRO.
As discussed in the keynote session, protocols are becoming more complex resulting in increasing amendments across the industry. The estimated average direct cost to implement a single amendment is nearly $1M. The complexity of protocols is also tied to patient burden and retention. It was cited that in oncology only 22% of subjects complete studies.
It was clear that better enrollment, timelines and patient engagement equal compelling opportunities for drug developers and CROs alike.
One presentation highlighted how to expedite the start-up phase of a clinical trial while another recommended the CRO copy sponsors on all site communications, which allows for transparency and prompt responses. It is crucial to remember to establish a comprehensive data cleaning process to ensure a consistent process for data integrity and reliability.
Sites with limited staff appreciate task prioritization and ensure the team focuses on critical activities. With certain studies, such as rare diseases, it’s important to consider beyond the protocol—who are the key opinion leaders or how can prioritize site satisfaction to enhance patient outcomes and strengthen sponsor partnerships.
Although many of these tips are actions Catalyst Flex already applies, the presentations were helpful in explaining a different approach toward these standards or reinforcing best practices.
Operational strategies and excellence
In fact, a presentation by a Catalyst client we have worked with on a few studies used examples based on operational strategies Catalyst has in place. Even though CRO partners were not named, our flexible approach and the fact that we are very collaborative are obviously appreciated and welcomed by our sponsors.
Catalyst Flex is a perfect partner for small and medium biotechs as they appreciate our ability to be flexible and nimble with our support. The Catalyst Flex model appeals to those who may not think they are looking to outsource all the work or not all the work at the same time. Our model works well with
- single resource support
- single function
- multi-resource
- function and into execution of a full study
By focusing on operational excellence, research can be conducted more efficiently with improved patient engagement and better overall outcomes.
Finally, with the increased challenges and complexities in today’s clinical development, outsourcing strategy demands to be re-examined. A one-sized fully outsourced model is not always the best approach. Blended models that include functional outsourcing are being implemented strategically. Sponsors of all sizes are exploring blended or FSP models to meet the demands of the growing complexity of protocols and clinical trials.
