How We Build Custom FSP Solutions to Rescue Trials

When studies stall or derail, sponsors need a clinical trial rescue strategy that’s fast, cost- & time-efficient, and experienced with highly qualified data experts. As a leading Biometrics CRO, Navitas Life Sciences has designed flexible, scalable Functional Service Provider (FSP) models tailored to meet diverse sponsor needs and budget constraints while delivering high-impact biometrics FSP solutions as a part of our trial rescue services.

Accelerate Regulatory Ready Data Delivery with a Trusted Biometrics Partner

Data accuracy and regulatory alignment are vital for the success of any trial. That’s why leading pharmaceutical and biotech companies partner with Navitas Life Sciences, a global functional service provider CRO, trusted for turning complex data into submission-ready outputs with confidence and clarity.

With one of the industry’s most experienced teams of biostatisticians, statistical programmers, and data managers, we deliver scalable solutions that support every phase of your clinical development. Whether designing adaptive trials, managing data for pivotal studies, or recovering at-risk programs, our expertise as a biostatistics CRO ensures first-time-right submissions, every time.

Tailored to your needs and built for speed, our flexible FSP model ensures seamless delivery from protocol to approval, helping you bring innovative therapies to patients faster and more reliably.

Flexible FSP Models Built for Real-World Demands

Our four-tiered FSP model structure allows us to seamlessly step in at any point in a trial’s lifecycle.

At Navitas Life Sciences, we understand that no two trials and no two sponsors are alike. Whether you need embedded expertise, full program execution, or agile short term support, our Functional Service Provider (FSP) models are designed to adapt to your operational structure, budget, and timeline.

• Dedicated Staff FSP
  Offers sponsor-controlled SOPs and project management while augmenting your team with additional bandwidth, including statistical programming services. This is ideal for maintaining internal oversight, scalable clinical trial support, and continuity.
• Embedded FSP
  Places our experts directly within your existing teams, ensuring seamless day-to-day collaboration, while Navitas oversees delivery with proven systems and leadership. Best suited for organizations looking for deep integration without added management load.
• Total FSP
  Transfers full execution responsibility to Navitas. This model ensures speed, consistency, and quality, empowering sponsors to focus on strategy while we ensure data-driven trial management.
• Project-Based FSP
  Designed for agility, this model delivers rapid, time-bound support. This is perfect for addressing urgent gaps, budget constraints, or rescuing high-risk studies with minimal disruption.

No matter which model you choose, you benefit from our hallmark strengths of consistent service excellence, clear accountability, optimized cost-efficiency and global scalability. With over 30 years of proven success in delivering reliable FSP partnerships, Navitas Life Sciences empowers sponsors with the flexibility, expertise, and high-quality data solutions.

Why Sponsors Choose Navitas to Rescue Trials

When timelines are compressed, quality is compromised, or trial integrity is at risk, sponsors turn to Navitas Life Sciences for proven trial recovery solutions built on speed, expertise, and certainty. Whether mid-study recovery or full-program takeovers, we deliver stability, efficiency, and expertise when it's needed most.

• Dedicated, Experienced Teams that Hit the Ground Running
  Our rescue approach begins with rapid deployment of expert professionals. Each team is handpicked for the therapeutic area, trial phase, and complexity at hand. From seasoned biostatisticians, data managers, and statistical programmers to clinical operations and governance leads, every team member brings hands-on experience and domain mastery, minimizing ramp-up time and maximizing immediate impact.
• Accelerated Time and Cost Efficiencies
  Sponsors under pressure don’t have the luxury of trial and error. That’s why we deploy streamlined workflows, proven risk mitigation strategies, and robust digital project controls that restore program velocity. Our centralized oversight and hybrid delivery model offer significant cost efficiencies without compromising oversight or accountability.
• Tailored Strategies Backed by Decades of Therapeutic Expertise
  Our teams craft bespoke recovery roadmaps informed by deep therapeutic expertise, real-time trial analytics, and a legacy of successfully salvaging critical programs. Whether the challenge is underperforming vendors, delayed data, or poor patient recruitment, we diagnose root causes fast and respond with precision.
• Commitment to Compliance and Quality
  In the urgency of trial rescue, quality is never a trade-off. Every solution we deploy aligns with global regulatory expectations including FDA, EMA, and CDSCO. Our stringent SOPs, internal QA checks, and risk-based monitoring practices ensure scientific rigor and regulatory compliance.

Program Management That Powers Progress as a Sponsor-Centric FSP

At Navitas Life Sciences, project success is strategically managed, monitored, and optimized through a proven, disciplined program management framework. Our dedicated project managers play a pivotal role in aligning cross-functional teams, mitigating risks, and accelerating outcomes across complex clinical programs.

• End-to-End Oversight
  From milestone tracking to overall program alignment, our managers ensure continuous visibility and control across all activities, helping sponsors stay ahead of potential delays.
• Seamless Accountability
  With clear accountability across teams, delivery is not only timely but consistently high in quality.
• Time and Budget Assurance
  Whether the project is mid-stream or being rescued, our PMs drive completion within scope and timelines, leveraging predictive tools and performance metrics.
• Cross-Project Intelligence Sharing
  Our model enables knowledge transfer and risk mitigation across programs, ensuring that every learning benefits the next study.
• Decision-Ready Reporting
  With standardized templates and data-driven dashboards, including client-preferred formats, sponsors have what they need to make quick, confident decisions.
• Governance with Foresight
  Through a 3-tiered governance structure, we don’t just solve today’s problems—we proactively shape tomorrow’s solutions.

This approach ensures strategic program orchestration, designed to create a seamless, scalable experience for sponsors struggling with complex clinical landscapes. At Navitas, precision meets partnership, and it starts with how we manage your trials.

Built for Speed. Designed for Agility. Trusted for Recovery.
Whether stepping in as a full partner or supplementing sponsor teams, Navitas Life Sciences brings the flexibility and capability needed to rescue complex trials without sacrificing quality or timelines. Our FSP models are customizable lifelines for success.

No matter which model you choose, you benefit from our hallmark strengths of consistent service excellence, clear accountability, optimized cost-efficiency and global scalability. With over 30 years of proven success in delivering reliable FSP partnerships, Navitas Life Sciences empowers sponsors with the flexibility, expertise, and high-quality data solutions.

Case Study of a Rescue Trial: When Every Hour Counts, Precision Matters

Discover how Navitas Life Sciences rescued a critical Statistical Programming project in just 8 weeks, delivering ahead of schedule, over the holidays, and exceeding every expectation.



• Sponsor Need:
  Facing poor quality outputs, inexperienced programming, and looming deadlines, a U.S.-based biopharma urgently needed a capable partner to take over from their underperforming CRO.
• Impact:
  Navitas stepped in with agility, expanding teams across geographies, mobilizing leadership, and submitting all deliverables ahead of time.
• Result:
  A long-term partnership, six studies awarded, and a complete CRO transition.
• Key Highlights:
  • How we scaled an experienced 40-member global team in <2 weeks
  • Strategies for seamless project handover and delivery during peak holiday season
  • Why sponsors rely on our FSP model to rescue high-risk clinical programs
Read NOW:
Rescuing a Critical Statistical Programming Project for a Leading Biopharma Company

To know more about our services and solutions, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it.

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