CASE STUDY : Rapid and Effective Scalability
Stiris Research was awarded a contract to perform project management, clinical monitoring and medical monitoring for a suite of six North American clinical trials (2 – Phase I, 3 -Phase III, and 1 – Open-Label) including one study with an adolescent population.
These projects had quick timelines with the first SQV scheduled for just two weeks after the Kick-Off Meeting and FPI projected for two months later, but in order for that to be accomplished, IRB submissions/approval needed to be obtained and IP, a controlled substance requiring DEA and OCS approval and licensing, would need to be shipped to sites in both the U.S. and Canada.
GROW TO SUPPORT THE PROJECT’S UNEXPECTED NEEDS
This was a multi-trial clinical program involving 126 sites with some sites participating in more than one of the six studies. The Sponsor originally intended to manage the regulatory submissions, IP management, and budget negotiations for this program, but ultimately these tasks were absorbed by Stiris as the study met the following unexpected hurdles:
- Regulatory Submission to the U.S. FDA: IND delayed.
- Submission to the Office of Controlled Substances (Canada): Sponsor submitting but getting the information from sites to complete the submission was taking time.
- S. Drug Supply Shortage: Caused a hold in the study while the drug was being transported.
Ultimately, the aforementioned factors resulted in FPI being delayed and/or extended by 5 to 9 months across the program of studies.
Other challenges included:
- Labs in Canada: Border issues and hot temperatures in lower states required mitigation and specific training and re-education for sites experiencing issues.
- Standardized Scales: This study involved multiple scales which meant organization and management of validation, copyright, translation, and training.
- Regulatory documents and budget negotiations – Sponsor asked Stiris to take over management of the site’s regulatory document packages and budget negotiations just two months into the study in hopes that the site start-up process could be expedited.
- Drug (IP) shortage: To accommodate the shortage of certain doses in the U.S., Stiris managed site-to-site transfers to ensure adequate IP supply at actively enrolling sites.
- Accelerated Timelines: Despite the delayed start-up, one specific study experienced rapid enrollment and, the database lock timelines were moved up by many months.
RESPONSIVE COLLABORATION and RAPID ADAPTATION
When the IND was delayed, Stiris communicated with all the sites to reassure them that the project was still ongoing and not going to be stopped.
The Stiris Project teams communicated constantly with the sites to ensure they remained interested and expedited budget and contract negotiations as well as IRB submission and regulatory document management to ensure that when the IP was ready, sites could be quickly activated and start enrolling.
When insufficient quantities of drug was received in the US this cause a US hold on the study while the IP was being transported. Sites were made aware of this as soon as Stiris was notified and screening schedules were amended to accommodate patient visits on the study. Sites were updated frequently during this time and Stiris coordinated the transfers of IP from site to site to allow high enrolling sites to continue to screen subjects.
As the issues arose with temperature control during the border delays, Stiris arranged with Sponsor for additional/better coolers to be supplied to sites where the overall weather and hot temperatures persisted and Stiris ensured that all sites were trained on these adaptations.
Stiris worked with the all the sites where study scale supply concerns were raised. Stiris ensured that all site questions were responded to in a timely manner, training on scale scoring was provided, and a training guide for sites was developed the request of the Sponsor.
When enrollment exceeded expectations, Stiris added more team members to accommodate these accelerated timelines and also increased the frequency of monitoring visits. Ultimately, this program enrolled and completed all subject activity in a period of 11 months.
- The Stiris team are strong communicators and exercised their good rapport with sites to work quickly and effectively at navigating the multitude of unexpected delays that occurred during the study.
- Due to the flexible and scalable nature of Stiris, the project team was able to rapidly evolve to the situation and add team members as needed to absorb the additional activities and services required.
- Stiris was able to keep the momentum on the study with minimal delays and was able to adjust monitoring needs and database lock timelines as needed.