Background and Challenges
A first-in-human trial is incredibly important for early-stage medical device companies. Selecting the right CRO partner is a crucial component of gathering required clinical data for subsequent studies. A cardiovascular device company (Company) faced the challenge of poor quality and inconsistent data collection and trial management, potentially jeopardizing future study applications. Without internal resources to dedicate completely, they needed an experienced partner who could get up to speed, transfer the trial, and close gaps as quickly and for as little budget as possible. Key challenges included:
- Ensuring data collection continuity while the new systems were being built and brought online.
- A disorganized trial management system and insufficient trial procedures.
- Missing key documents and data.
- Coordinating with international collaborators, who were frustrated with the current management.
ActiVie was brought in to “rescue” the trial by taking over all trial management, building all new systems and processes, importing and cleaning data, training all required personnel. Company had a goal of applying for the subsequent study with the FDA and presenting data at a conference in a few months.
The Solution
Leveraging their expertise and agility, ActiVie took on designing and building all new systems and ensuring trial management was compliant and easy for Company:
- Data-first Approach: ActiVie’s team of data experts developed all new CRFs within a week, mapped all old data to the new CRFs, imported and reviewed all data resulting in 1300 queries issued and resolved, and ensured sites burden was minimized during transfer.
- Comprehensive Trial Setup: ActiVie created all new trial management documents (SOPs, WIs, FRMs), built all new EDC, CTMS, and eTMF systems, and trained all trial team members globally on the new systems, all in a few months.
- Collaborative Efficiency: ActiVie facilitated cross-functional collaboration, ensuring that every aspect of the transfer process was executed smoothly, even across international borders.
This detailed approach enabled Company to transfer trial management successfully, meeting their project goals and supporting a subsequent study Q-sub meeting with the FDA and successful conference presentation.
Cost of Not Partnering Right
The risks of not partnering with ActiVie had serious consequences for Company, including:
- System build & data management errors, leading to frustrated sites, delays, and errors in data entry.
- Delays in data analysis, which meant that sites were not provided timely feedback on data entry or image collection, sacrificing quality in data available for analysis.
- Increased operational costs due to the need for a new team to build and implement all new trial systems and procedures.
Why ActiVie
ActiVie stood out as the ideal partner for Company due to their:
- Fractional Scientist Model: ActiVie provided flexible, expert-driven support without the need for full-time employees, making the project cost-effective.
- Cross-Functional Expertise: ActiVie’s ability to manage complex tasks while collaborating across teams ensured a seamless and efficient transfer process.
- Data Continuity Focus: The team’s meticulous attention to detail ensured that the data were comprehensively reviewed, ensuring integrity.
- Operational Efficiency: While adding cost initially to rebuild all systems and procedures, ActiVie provided services at a 40% cost savings overall compared to the previous CRO.
The Outcomes
The collaboration between ActiVie and Company resulted in:
- A seamless transfer process that delivered error-free, reliable trial systems with minimal site burden.
- Improved user experience, with platforms that were intuitive and easy to use.
- Well-organized data that were easily accessible to internal and external users.
- Cost savings for Company in the long-term, eliminating the need for full-time employees or external IT support.
With ActiVie’s expert support, the Company was able to meet their UAT goals and ensure data accuracy, positioning them for long-term success in their study operations.