Specialty Medical Device Company Accelerates Study
Builds with Functional Service Provider Partnership Case Study
PROJECT BACKGROUND
Medical device clinical trials come with unique requirements including growing regulatory scrutiny and the need for data integration and speed to market. As a result, device companies often face challenges in effectively building out clinical trial electronic data capture (EDC) systems that can accommodate their studies across the lifecycle of their products.
THE CHALLENGE
A medical device company specialized in developing innovative solutions for an area of high unmet need sought to improve their study build process. The company’s portfolio of medical device studies is diverse, with requirements varying significantly from study to study. Additionally, the company has a range of specific requirements as a study sponsor, calling for an EDC build approach that the client could tailor to meet their unique needs, and that would be flexible enough to
COMPANY PROFILE
■ Medical Device Company in Niche Indication
■ Headquartered in United States
■ Approx. 150 employees
PRODUCTS UTILIZED
■ Clinical Data Acquisition
■ Functional Service Provider
accommodate changes between studies. The sponsor has an expert, but small clinical data management and clinical programming internal team so needed to ensure exceptional quality and strong working relationships with their outsourced partner. In addition, due to the number of studies which the group expected to handle, they wanted to embed efficiencies over sequential builds and accelerate their kick-off meeting to database go-live timeline.
The company approached the team at eClinical Solutions to discuss their needs and potential solutions. The eClinical Solutions team proposed a functional service provider (FSP) partnership model for electronic data capture implementation, to allow the client to develop the desired efficiencies over time and ensure a consistent team to work as an extension of their own organization.
A functional service provider (FSP) model involves the outsourcing of specific functions enabling sponsors to access the expertise of specialists. FSP models typically imply longer-term partnerships, with clients benefiting from flexibility, scalability and the ability to outsource based on core competencies.
The teams began by defining roles and establishing positive, direct communication processes between the internal team and the hands-on eClinical Solutions team of clinical programming
RESULTS
subject matter experts. This approach facilitated immediate feedback and rapid iterations, enabling eClinical’s assigned team to adapt seamlessly to the specific processes of the medical device client.
Through direct and open engagement, the teams quickly developed a mutual understanding of the company’s unique study needs, leading to more customized and efficient solutions.
The introduction of a lead programmer to oversee all activities streamlined communication and ensured swift, direct resolution of queries and issues with greater transparency.
Over the course of multiple studies, the eClinical Solutions team demonstrated a commitment to understanding the medical device company’s evolving needs and preferences. This dedication to client satisfaction and active collaboration fosters trust, which is critical to fully transfer learnings from one project to the next.
The medical device company, through its partnership with eClinical Solutions was able to significantly enhance the efficiency and effectiveness of its clinical trial study builds. This allowed them to achieve repeatable outcomes across various studies, regardless of each study’s own unique needs.
The new study build process has accelerated study build timelines, improving the average kick-off meeting to go-live timeline to 4-6 weeks and accelerating the overall device development process. The strong relationships and well-established processes are not only bringing about faster go-live times, but also resulting in minimal post-go-live queries, reflecting high-quality. Through a close, collaborative approach to study build improvement, the medical device company now has an EDC solution in place that can be easily configured and scaled to meet the unique demands of its ongoing programs of trials.
Success Factors
■ 15-year partnership with Medidata and broad portfolio of 7 accreditations ensures the flexibility to customize and build solutions across therapy areas and trial types.
■ End-to-end lead programmer assignment and executive oversight streamline communication and simplify delivery.
■ Global clinical programming team delivers high value and maximizes productivity across time zones
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