Company Profile
Name: Optinose US, Inc.
Type: Sponsor – Specialty pharmaceutical company
Therapeutic Area: ENT & Allergy
# of Employees: >100
Previous Solution: Large EDC system
Client Challenge
Optinose, a specialty pharmaceutical company focused on the development and commercialization of products for patients treated by ear, nose and throat (ENT) and allergy specialists, was on the search for a flexible, user-friendly electronic data capture (EDC) system for an upcoming study. As an organization focused on maximizing resources and historically outsourcing data management services, Optinose was interested in finding a solution they could use in-house. They were looking to gain more control over their EDC environment and develop a partnership with their technology vendor as key criteria in their selection process.
The team at Optinose decided the optimal approach was to adopt an EDC system that would enable their data manager to directly set up and oversee the data collection process. Optinose had other studies running in a large EDC system, but felt the new study was a perfect opportunity to implement an in-house, value-based platform.
Lastly, they were looking for the chosen system to ensure reusability of forms, user profiles, edits checks, and workflows from study to study.
Client Needs
- User-friendly, intuitive EDC system
- Ability to build studies in-house with limited reliance on external vendors
- Technology partner with strong reputation for customer service / support
- Flexibility to configure/implement in-study changes such as protocol amendments
- Multilingual capabilities
- Reusability of study components
Resolution
Crucial Data Solutions (CDS) met with Optinose to gain a deeper understanding of their needs and objectives in order to clearly identify where CDS could be a true partner throughout this process.
Optinose’s data manager received training from CDS, allowing Optinose to design and manage their own study in TrialKit. This allowed the data manager to create a practice study in TrialKit’s sandbox based on the protocol. The practice study served as a way to demonstrate to Optinose’s Global Clinical Operations team how the TrialKit platform would effectively support their study. This also saved considerable time as the case report forms (CRFs), visits, and configurations from the practice study were carried over to the production study.
The flexibility and user-friendliness of TrialKit stood out to the Optinose team as clear benefits of the platform. TrialKit made it possible to perform multiple changes to the database throughout the course of the study. Optinose was easily able to make a number of changes to the study database without having to rely on a third party to do it for them. Optinose recognized that TrialKit’s flexibility saved some effort, time, and money when compared to other solutions. Those previous solutions required change orders and lengthy wait times for a resolution.
Results
- Self-sufficiency achieved
- Gained a true partner
- Deployed a highly flexible, multilingual platform with intuitive user interface
- Ability to reuse study components
- Implemented global application
Client Benefits
Optinose and CDS developed a partner relationship rather than just a vendor relationship. Optinose stated that this was “absolutely the case because CDS’ Support team was invaluable and accessible every step of the way.” Optinose reported they would be comfortable considering TrialKit again based on the ongoing success of the partnership. They summarized the benefits they’ve realized to date as follows:
- Realized significant value at a price within budget for the study
- Ability to build and manage an entire study in-house with minimal assistance
- No change orders or out of scope issues
