Scale globally and accelerate your development, even when you’re short on resources. Our Functional or Full service provider (FSP) model offers flexible, custom services designed to help you manage clinical trial costs while maintaining or improving quality.

When you have clinical data management hurdles to clear, or statistical programming puzzles to solve, Nova Bio Solutions delivers. Get high-quality data in submission-ready format from our certified experts. Because of our industry-leading employee retention, you’re assured a consistent team that understands your systems, processes, and expectations.

ASSESSING REGULATORY AND MARKET ACCESS PATHWAYS

Nova Bio Solutions works with startups and other early-stage innovators to assess the optimal regulatory and reimbursement pathways for your product. Defining an integrated regulatory and reimbursement approach is essential to maximize your return on investment in clinical and economic evidence coordinating an approach that meets the needs for market authorization and can also satisfy the needs of payers for coverage reimbursement. This approach ensures that your evidence development road map is optimized to deliver agency approval and reimbursement success.

DEVELOPING THE CONCEPT AND REQUIREMENTS

Our teams create and iterate prototypes, prove technical feasibility, and gather feedback to understand the user experience. We leverage human-centered industrial design, digital product design, and human factors expertise to translate insights from research into product solutions and experiences. We do this all with a focus on building a solid design history file with clinically relevant requirements, risk management, and regulatory strategy. This phase finishes with careful planning around budget and timing needs for the entire program  reducing investment risk and positioning you for future development stages.

GETTING YOU TO A FINAL ENGINEERED DESIGN

We help emerging innovators move from early concepts into focused, detailed, engineered solutions completed under design controls. To achieve this, we integrate human factors engineering and human-centered industrial and digital design into fully functional, single systems suitable for usability and engineering evaluation. This phase also encompasses risk management activities, like FMEAs, engineering verification testing, and design verification planning all leading to the final engineered design.