2025 FSP Insights

Posted on 15 October 2025

​​Partnering with the Right FSPs in 2025: Insights from Luminary Group

Clinical research is evolving faster than ever. Innovative therapies, decentralized trial designs, and growing regulatory complexity mean that the right partner can make or break a study. At Luminary Group, we help life sciences companies identify Functional Service Providers (FSPs) that don’t just deliver a service — they become an extension of your team.

Here’s what we’re seeing in 2025 and how to approach choosing your FSP strategically.

What is an FSP?

Functional Service Providers (FSPs) handle specific pieces of your clinical trial rather than managing the entire project. They are specialist teams: biostatisticians, data managers, medical writers, or clinical monitors who slot seamlessly into your program where you need extra capacity or expertise.

Why this matters: You maintain focus on your core strengths while relying on specialists to handle complex or resource-intensive parts of your trial.

Why FSPs Are Becoming Indispensable

Recent trends highlight why FSPs are no longer just optional support — they’re strategic partners:

Decentralized & Hybrid Trials: Remote monitoring, wearable devices, and telemedicine require FSPs with digital fluency and operational flexibility.

Data Explosion : With genomics, biomarkers, and real-world evidence, teams need FSPs capable of handling large, complex datasets quickly and accurately.

Regulatory Complexity: Cell and gene therapies, rare disease studies, and international trials demand compliance expertise across multiple regions.

Global Footprint, Local Knowledge: Trials are spread across continents. Top FSPs combine scalability with deep local insight.

Flexible Engagement Models: Leading providers can scale from providing a few specialists to managing entire functional areas, adapting to your trial’s needs.

What Makes an FSP Stand Out

Not all FSPs are created equal. Here’s what to look for when matching your project with a partner

Scale & Agility: Can they grow with your project or pivot quickly if requirements change?

Therapeutic Expertise: Do they understand your disease area and anticipate challenges before they arise?

Tech-Forward Approach: Are they using predictive analytics, digital platforms, and AI to streamline trial operations?

Quality & Compliance: Strong audit history and regulatory know-how are essential.

Communication & Transparency: Regular, clear updates and proactive problem-solving matter.

Cultural Alignment: Their approach to patient care and ethics should mirror yours.

Top 10 Global FSP Providers (2025)

Here’s a snapshot of some of the providers shaping the functional service landscape today:

Company

Strengths

Best Fit For

IQVIA

Global scale, advanced data analytics, FSP 2.0 platform, deep therapeutic and data capabilities

Large, complex global programs requiring integrated FSP models

Parexel

Regulatory strategy, medical writing, translational medicine, and strong scientific engagement

Sponsors entering new regions or running regulatory-heavy studies

Fortrea

Dedicated FSP business post-Labcorp spin-off, robust biometrics, clinical ops, and site management infrastructure

Sponsors seeking scalability and mature FSP delivery backed by Covance heritage

ICON

Broad functional coverage, operational excellence, and high-performance global delivery

Large pharma outsourcing multiple functions or global portfolios

Syneos Health

Integrated clinical and commercial model, flexible delivery, and depth across therapeutic areas

Sponsors bridging early trials to market launch

Precision for Medicine

Biomarker-driven, hybrid trial support, biotech-centric delivery model

Innovative biotech, precision medicine, and cell & gene therapy sponsors

Quanticate

Specialist in biometrics, programming, and statistical analysis

Biotech or mid-sized pharma needing data-heavy FSP support

Premier Research

Rare disease and pediatric expertise, niche therapeutic specialization

Sponsors in orphan or small-population indications

Caidya (formerly Clinipace + dMed)

Tech-enabled FSP delivery, digital trial management, adaptive and cost-effective engagement models

Emerging biotechs seeking tech-driven, flexible FSP partnerships

PSI CRO

High retention, tailored engagement, and regionally strong operations

Biotechs valuing personalized service, consistency, and agile scaling

Choosing the Right FSP

When evaluating potential partners, consider:

> Experience in your therapeutic area and trial model

> Ability to operate across multiple regions at the required scale

> Strength of digital and data capabilities

> Compliance track record and risk management

> Flexibility to scale or adjust scope as your project evolves

> Cultural and ethical alignment​

Looking Ahead

The next few years will see an even stronger focus on:

> Integrating real-world data and digital endpoints

> Enhancing patient experience to improve retention and outcomes

> Sustainable trial operations with reduced environmental impact

> Navigating evolving global regulations and data privacy requirements

The right FSP becomes more than a service provider — they are a strategic partner helping you navigate complexity, accelerate timelines, and ensure quality.

Luminary Group Perspective

At Luminary Group, we specialise in executive search and talent solutions for the life sciences and biotech sectors. Our mission is to connect visionary leaders with organisations driving innovation, ensuring the right people are in place to shape the future of healthcare and scientific discovery. Whether you’re a company seeking top-tier talent or a professional exploring your next career move, we’re here to guide and support you every step of the way.

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