Clinical Operations
Embedded CRAs, CTMs, and operational leadership providing structured site oversight, study coordination, and execution support across early- through late-phase programs.
EMBEDDED EXPERTISE. GLOBAL DISCIPLINE. SCALABLE SUPPORT.
Functional Service Provider (FSP) Services
HiRO’s Functional Service Provider (FSP) model gives biotechs access to dedicated global expertise embedded directly within their teams. Built for emerging and growth-stage sponsors, our flexible approach aligns to your SOPs, systems, and timelines—providing the scalability you need without adding operational complexity.
Sponsors Trust HiRO’s Embedded FSP Model
HiRO builds dedicated functional teams that operate as a natural extension of your organization—aligned to your workflows, platforms, and development strategy. Our model allows sponsors to scale efficiently while maintaining consistency across study execution, data integrity, and regulatory readiness.
Each embedded team member brings deep functional expertise and works within your operational structure, ensuring seamless collaboration and minimizing internal management burden. This approach strengthens execution continuity while enabling faster, more confident decision-making as programs evolve.
* Confident * Flexible * Compliant * Urgent * Consultative * Global
* Confident * Flexible * Compliant * Urgent * Consultative * Global
* Confident * Flexible * Compliant * Urgent * Consultative * Global
* Confident * Flexible * Compliant * Urgent * Consultative * Global
* Confident * Flexible * Compliant * Urgent * Consultative * Global
* Confident * Flexible * Compliant * Urgent * Consultative * Global
* Confident * Flexible * Compliant * Urgent * Consultative * Global
* Confident * Flexible * Compliant * Urgent * Consultative * Global
Data Management
Expert teams of database programmers, clinical data associates, and data managers with deep experience across leading EDC platforms and clinical technologies.
Medical Writing
Experienced medical writers integrated into sponsor timelines and document strategies, delivering protocols, CSRs, investigator brochures, and regulatory-ready submissions with clarity and consistency.
Statistical Programming
and Analysis
Highly experienced, globally distributed programming teams delivering the expertise needed to support your program requirements and submission timelines.
Pharmacovigilance
Embedded pharmacovigilance specialists supporting case processing, safety review, and aggregate reporting—aligned to sponsor systems and global regulatory requirements.
Biostatistics
Expert-level lead and support biostatisticians skilled in guiding the design, analysis, and regulatory delivery of both standard and complex clinical programs.
Medical Review
Dedicated medical reviewers providing real-time clinical oversight, safety evaluation, and aligned medical review to support efficient program progression.
TAILORED FUNCTIONAL SUPPORT
Flexible FSP Services
On A Global Scale
With consistent communication, stable coverage, and globally aligned standards, our Functional Service Provider (FSP) model strengthens your most critical functions while preserving flexibility. Biotechs gain the predictability of embedded expertise and the confidence of knowing every task is handled with care, rigor, and transparency.
Focused Expertise. Predictable Delivery.
HiRO’s FSP services give biotechs access to specialized teams in Clinical Data Science, Pharmacovigilance, and Medical Monitoring – without the burden of expanding internal infrastructure. Our experts integrate seamlessly into your workflows, bringing the same discipline, processes, and clarity that define our full-service approach.
Clarity That Strengthens Every Decision.
Our teams communicate with the calm, steady transparency biotechs rely on. Whether supporting a fullservice program or an FSP engagement, we provide clear expectations, structured updates, and guidance founded in real-time data. You get insight you can trust – and the confidence to move forward with clarity.
FREQUENTLY ASKED QUESTIONS
Is The FSP Program
Right For Your Study
What is an FSP model?
An FSP (Functional Service Provider) model provides dedicated functional experts–such as biometrics, clinical operations, medical writing, or pharmacovigilance–who integrate directly into the sponsor’s organization. Unlike traditional outsourcing, FSP resources operate inside client systems and SOP’s while remaining fully managed by the provider.
How is FSP difference from full-service CRO support?
FSP delivers people, not projects. Sponsors maintain control of study strategy and timelines while gaining scalable execution capacity. This eliminates layered project management and allows faster decision-making.
Why do sponsors choose FSP?
Sponsors typically adopt FSP to:
- Scale teams quickly without permanent hiring
- Access specialized expertise on demand
- Improve cost predictability
- Reduce operational burden
- Maintain internal ownership of programs
- Accelerate delivery timelines
Are resources dedicated?
Yes. Teams are 100% sponsor-aligned and not shared across accounts–ensuring consistency, accountability, and program continuity.
How fast can you deploy?
Initial resources can typically onboard within 2-4 weeks, depending on role complexity and system access. Expansion is continuous as pipeline demand grows.
What functions can be supported?
Most sponsors start with one function and expand over time:
- Biometrics (statistics, statistical programming, data management)
- Clinical Operations
- Medical Writing
- Pharmacovigilance / Safety
- Study Startu-Up
How do you ensure quality and performance?
Each FSP program includes:
- Defined KPIs and service-level expectations
- Weekly operational touchpoints
- Monthly executive oversight
- Proactive backfill support
- Continuous training and QA alignment
How does FSP improve costs compared to contractors or multiple CROs?
FSP replaces fragmented vendors and high contractor churn with:
- Standardized rate cards
- Lower attrition
- Reduced onboarding costs
- No duplicated overhead
- Predictable monthly spend
This delivers measurable cost efficiency over time.
Can we scale up or down?
Yes. Resource levels flex based on study demand–without recruitment delays or internal HR burden.
What makes this model attractive for emerging biotech?
FSP allows biotech sponsors to access senior expertise and operational scale without building large internal teams—supporting rapid growth while preserving capital.
What business outcomes should sponsors expect?
Clients typically see:
- Faster database locks and deliverables
- Improved audit readiness
- Reduced internal workload
- Greater consistency across programs
- Increased pipeline velocity
Is FSP Right For You?
