Overview
A clinical-stage genetic medicines company is pioneering precision delivery technologies for mRNA and gene correction therapeutics. They are developing treatments for rare genetic diseases with limited treatment options, focusing on respiratory conditions with high unmet medical needs.
Phase: I/II
Sites: 23
Countries: 4
The Challenge
As a company targeting a specific genetic condition resistant to existing therapies, the biotech faced the daunting task of recruiting patients who met strict inclusion criteria. With such a challenging patient population, losing even a single patient due to drug supply issues was not an option.
The company initially conducted Part 1 of their multi-part clinical trial without an RTSM provider. They relied on manual processes using Excel spreadsheets and email for the early portion of the study. However, the team experienced significant overhead and logistics challenges as a result of the decision to start the trial without RTSM.
These challenges led the team to reassess their RTSM approach for Parts 2 and 3 of the trial. They recognized that manual processes would be too resource-intensive to continue in later stages of the study and that proceeding without RTSM software could jeopardize their already challenging patient recruiting process by not having sufficient drug available at the sites for patient dosing. Recognizing these challenges and risks, the biotech decided to bring in an RTSM provider for Parts 2 and 3 of the trial to ensure a more efficient and effective study execution.
As a small biotech, the company acknowledged the risk of being deprioritized by large, legacy RTSM vendors who tend to focus their attention and expert-level resources on larger sponsors. This deprioritization would likely lead to slower response times, lack of personalized expertise, and inflexibility in accommodating their unique requirements as they moved into later phases of the trial.
“We were really looking for a high-touch vendor who would be available and flexible to changes. When you’re a smaller company, if one of your vendors is too large, they’re not going to provide the service you need. What ends up happening is the vendor naturally prioritizes its other clients and smaller groups like us get lost in the shuffle. It’s really hard for them to walk in our shoes with us through the course of a given trial that is pivotal to our company’s future.”
-Head of Clinical Operations
The Korio Approach
Korio emerged as the ideal RTSM partner, with a leadership team bringing 100+ years of combined industry experience and a dedicated project manager with over 15 years of RTSM expertise. They adopted a hands-on consultative approach to the RTSM design, guiding the team through the study setup process, sharing best practices, and remaining available for ad hoc discussions and updates throughout the project. As the trial’s timelines evolved, Korio seamlessly adapted to support the company every step of the way, from initial design through go-live and beyond.
“I would like to make sure we recognize Korio for the AMAZING job they have done to get our RTSM live on time to meet our international sites’ enrollment needs. In addition, making themselves available for our ongoing changes, training, questions, and meetings with our other trial vendors- basically anything we need to support this trial through its completion. Korio is truly a pleasure to work with.”
-Senior Clinical Trial Manager
The Korio RTSM system automated the biotech’s supply logistics, increased the visibility of the supply chain including ancillary device tracking, and ensured the availability of investigational drug for all patients as they enrolled in the trial globally.
User friendly experience:
Intuitive, role-specific interface for operations, supply, and Site endusers, with easy access to key data and reporting
Comprehensive tracking:
Managed the IP and its delivery device seamlessly via the RTSM system
Designed for change:
Korio RTSM anticipates protocol amendments, allowing the seamless transition to planned and unplanned trial changes
Outcome
Through their partnership with Korio, the biotech achieved significant improvements in their clinical trial supply operations:
- Reduced manual effort, allowing the team to focus solely on running their study without worrying about supply logistics
- Minimized the risk of participant loss due to inadequate drug and device supplies
- Enhanced data quality and supply chain custody, critical for regulatory compliance
- Delighted sites report positively on the simplicity and clarity of using Korio’s system
These successes highlight the benefits small biotechs can achieve by partnering with a responsive, specialized RTSM provider like Korio.
With Korio, the company was able to avoid the common challenges of deprioritization and lack of personalized expertise that plague small biotech companies working with larger RTSM providers. This allowed them to remain focused on their core clinical research while relying on Korio’s seamless RTSM delivery and white-glove service.
Korio has good people—talented people—who know what they’re doing, who’ve done RTSM. People who have experience in clinical trials and know what our pain points are. Price-and service-wise, Korio was the perfect fit for us.”
-Head of Clinical Operations