LifeNet Health Scales Regenerative Medicine into the Global Market with Veeva EDC

When LifeNet Health, a global leader in regenerative medicine, prepared to launch its first product into an international market and scale its business, it quickly recognized the need to modernize its clinical approach. To compliantly accelerate clinical studies and product time-to-market, LifeNet Health transformed its operating model by moving away from manual processes to a scalable, compliant digital platform.

Kim Dorsch, vice president of global clinical affairs at LifeNet Health, highlighted the pivotal steps taken to accelerate data capture and improve clinical trial efficiency for their allograft biologics products.

Unlike pharmaceutical or medical device organizations, tissue banks like LifeNet Health can bring products to market without an investigational new drug application (IND), investigational device exemption (IDE), or biologics license application (BLA), provided they satisfy strict U.S. regulatory criteria around the recovery and processing of donor tissue for human cells, tissues, or cellular/tissue-based products (HC/TPs). However, in order to gain global market access, some regions and countries require compliance with medical device or biologics regulations, such as the EU Medical Device Regulation (MDR) and the Unique Device Identification (UDI) system. As a result, LifeNet Health’s clinical affairs team conducts rigorous post-market studies to support US reimbursement international regulatory submissions.

Prior to adopting Veeva, LifeNet Health managed studies manually with Excel spreadsheets and paper-based data collection forms (DCFs). For small studies (fewer than 50 subjects), monitors manually entered data collected at the sites twice and performed a spreadsheet comparison to pick up entry errors. Without a formal audit trail, the monitors were forced to complete data correction forms for every entry error, send that form back to the site, and wait for a response before fixing the discrepancy. As study sizes increased, the amount of time and effort required from LifeNet’s lean team made this process unsustainable.

When LifeNet entered into a sizable registry study involving 500 patients, it was clear they needed a scalable, compliant electronic solution. “We had to do something better. This was our chance from a clinical affairs standpoint to up our game… because this study was for our biggest product and it also came with a push to get it into international markets,” Kim Dorsch, vice president of global clinical affairs.

After a rigorous evaluation process, LifeNet Health chose to implement the Veeva Clinical Platform, which provided a single, unified platform for EDC, CTMS, and eTMF allowing the company to streamline disparate workstreams and to scale, even with the constraints of a nonprofit. They also needed a platform with high security compliance standards to ensure no risk of security breach.

LifeNet Health adopted Veeva EDC to help parse through their 500 patient registry study, streamline processes, and ensure data integrity and quickly saw significant gains, including:

• 90% reduction in site metric calculations
• Monitoring costs cut by one-third
• 58% Reduction in study build time (from six weeks to 17 days)
• Reusability of 50% of standard forms across studies

The registry study, focused on a cellular bone allograft product, marked a turning point for LifeNet. The organization used this study to secure international market entry, move away from outdated data collection processes, and build internal support for expanding their digital infrastructure.

LifeNet utilized their expanded digital infrastructure to standardize core processes, enhance data traceability, and simplify internal audits. Real-time reporting enabled visibility into enrollment, screen failures, and site performance, all critical data points for both operational oversight and responding to regulatory inquiries. Dorsch highlights “Our first build took a little over 6 weeks, but we’ve now streamlined it down to just 2.5 weeks and we’ve reused about 50% of our standard forms, which has made each successive study startup significantly faster.”

LifeNet saw an opportunity and transformed their clinical operating model to provide a better patient experience, expand reach into new markets, and drive operational efficiency. Dorsch shared four key lessons learned for other organizations looking to achieve similar results:

1. Start with a scalable foundation: Begin with core functionality and expand strategically

2. Build cross-functional buy-In: Clinical, IT, and quality teams all play vital roles

3. Prioritize compliance: Design every study as if it will be submitted to regulators

4. Drive efficiency through reuse: Standardized forms and templates can help accelerate future builds

Building on the success of Veeva EDC, LifeNet Health plans to integrate Veeva Payments to automate site reimbursements and streamline regulatory document updates to further optimize its clinical approach.. The company is also exploring Veeva Regulatory Information Management (RIM) and Quality Management (QMS) applications. For more details about how to get started, read about how the Medtech Industry Establishes Foundation for Clinical Trials with Veeva MedTech.