FSP Solutions

Flexible Functional Service Provider (FSP) Solutions Tailored to Your Needs.
Accelerate your clinical development with ProPharma's expert-driven, scalable FSP services.

fsp-solutions-desktop fsp-solutions-desktop

100 +

FSP client partnerships across multiple functional areas

1500 +

Global specialists providing dedicated functional and therapeutic area expertise

40 +

Years of FSP leadership and relationship building experience

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Your Trusted Partner in Clinical Excellence

Flexible FSP Solutions for End-to-End Clinical Success
Our scalable, expert-driven model integrates seamlessly into your operations - reducing timelines, enhancing quality, and driving efficiency across the clinical lifecycle.
  • 20+ years of experience across diverse therapeutic areas.
  • Global presence with a deep understanding of regional regulatory landscapes.
  • Dedicated teams ensuring consistency and quality throughout the project lifecycle.

Clinical Operations

  • Site Monitoring and Management: Ensure compliance, data quality, and patient safety with highly trained CRAs and project managers.
  • Study Start-Up and Feasibility Assessments: Expedite study initiation with site feasibility, regulatory document collection, and startup execution support.
  • Site Contracting and Budgeting: Accelerate site activation through contract negotiation, fair market value assessment, and budget harmonization.
  • Clinical Supply Management: Optimize the distribution and tracking of clinical materials to ensure continuous study supply.
  • TMF Management and Maintenance: Maintain inspection readiness with real-time TMF health checks and ongoing QC support. 
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Data Sciences

  • Data Management: End-to-end data handling including data entry, query resolution, and database reconciliation.
  • CRF Design and EDC Builds: Efficient and compliant electronic systems tailored to study needs.
  • Data Cleaning / Validation: Ensure high-quality data with targeted edit checks and validation programming.
  • Database Lock Activities: Streamline the lock process with a focus on speed, accuracy, and audit readiness.
  • Data Integration and Transfers: Secure, compliant handling of data mapping and cross-system transfers.

Biostatistics

  • Study Design & Protocol Development: Collaborate with sponsors to build scientifically rigorous study protocols.
  • Statistical Analysis Plan (SAP): Create detailed SAPs compliant with ICH guidelines and submission standards.
  • Adaptive Design: Implement flexible trial designs that accommodate modifications while maintaining statistical validity.
  • Statistical Programming: SAS-certified programming experts ensure efficient outputs for TFLs, ADaMs, and CDISC-compliant datasets.

Medical Writing & Quality Control

  • Protocol & Amendments Development, IBs, CSRs: Scientifically sound content aligned with ICH, FDA, EMA, and other global guidelines.
  • Clinical Evaluation Plans (CEP) and Reports (CER): Expert-driven creation of documents for device trials and MDR compliance.
  • IND/NDA/MAA Submission Documents: Strategic support for high-quality global submissions.
  • Comprehensive or Targeted QC Reviews: Thorough document review to ensure clarity, accuracy, and consistency.
  • Editorial QC Reviews: Language, formatting, and compliance checks by seasoned scientific editors.

Decentralized Clinical Trials

  • In-home Nursing Services: Certified nurses conduct on-site visits to support decentralized protocol needs.
  • Site Support and Research Assistance: Enhance site capabilities with remote and onsite staff trained in hybrid trial execution.
  • Patient Recruitment and Retention Strategies: Proven methods and technology to engage and retain diverse patient populations.

Real World Evidence: Clinical FSP Solution Brought in to Rescue a CRO 

When a longtime PV client faced critical delays because their CRO could not provide the necessary monitoring support, they turned to ProPharma. Within days, two CRAs and a Clinical Trial Manager were deployed to stabilize the study, oversee the struggling CRO, and ensure the Sponsor stayed on track to meet corporate goals.

“Thank you for stepping in and running with it. You both were brought in at a very crucial time and made a difference in helping BioXcel Clin Ops meet aggressive timelines set for us!

Having our own dedicated CRA’s was a big win, and it is something I will try and incorporate into our business processes in the future.

Your expertise, flexibility and competence helped us achieve this critical milestone. Hopefully, you are enjoying some recovery time now.”

Rashmi Deshpande
Head Clinical Operations, BioXcel Therapeutics, Inc.

Real World Evidence: Clinical FSP Solution Brought in to Rescue a CRO 

When a longtime PV client faced critical delays because their CRO could not provide the necessary monitoring support, they turned to ProPharma. Within days, two CRAs and a Clinical Trial Manager were deployed to stabilize the study, oversee the struggling CRO, and ensure the Sponsor stayed on track to meet corporate goals.

“Thank you for stepping in and running with it. You both were brought in at a very crucial time and made a difference in helping BioXcel Clin Ops meet aggressive timelines set for us!

Having our own dedicated CRA’s was a big win, and it is something I will try and incorporate into our business processes in the future.

Your expertise, flexibility and competence helped us achieve this critical milestone. Hopefully, you are enjoying some recovery time now.”

Rashmi Deshpande
Head Clinical Operations, BioXcel Therapeutics, Inc.

Flexible Engagement Models

At ProPharma, we don't believe in one-size-fits-all. Our Functional Service Provider (FSP) solutions are built around your goals, your teams, and your timelines — giving you the flexibility to evolve without disruption.

  • Tailored to Fit: Our fit-for-purpose models are customized to align with your internal processes, therapeutic focus, and organizational culture — maximizing team synergy and project adoption.
  • Scalable by Design:Whether you're expanding a global trial or need short-term support in a key function, our models scale with precision — ramping resources up or down based on your real-time needs.
  • Seamless Integration: We embed with your teams — not just beside them. From day one, our experts operate as true partners, driving aligned goals and unified execution.
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Medical professionals business professionals working at a conference table

Therapeutic Expertise

  • Areas of Specialization: Oncology/immunology, cardio-metabolic, CNS, Rare Diseases, Infectious Diseases, and more.
  • Experience: Highlight successful projects and case studies demonstrating therapeutic area expertise.

Global Reach with Local Insight/Oversight

  • Worldwide Presence: Operations in over 30 countries, ensuring global coverage.
  • Local Expertise: In-depth knowledge of regional regulations and cultural nuances

Why Choose ProPharma?

Partner with a team that scales with your needs and exceeds your expectations.

Experienced Talent, Ready to Deploy
Access a global network of highly qualified professionals across clinical, data, regulatory, and quality functions – with the expertise to plug in fast and deliver results.

Relentless Commitment to Quality
Every engagement is grounded in industry-leading quality systems, compliance protocols, and a proactive approach to risk mitigation.

Client-First, Always
We operate as an extension of your team, with transparency, accountability, and a shared focus on your goals – not just deliverables.

Flexible. Scalable. Strategic.
Our FSP model is built for growth, pivoting as your study needs evolve. From niche biotech to global pharma, we adapt to your rhythm.

Business worker working around a conference table

Our FSP Solution Experts

  • Kevin Wysocki Bio Photo

    Kevin Wysocki

    President, FSP Services

  • Janice Worley Bio Photo

    Janice Worley

    Global Head, FSP Services

  • Cynthia Fuller Bio Photo

    Cynthia Fuller

    FSP Medical Writing Division Head

Functional Service Provider (FSP) Value Proposition

At ProPharma, we forge strategic partnerships with our clients to collaboratively devise optimal strategies and drive remarkable results and operational excellence. With our cutting-edge FSP...

Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

Scaling resources for clinical trials can be a daunting task, especially when demands fluctuate over time. In this case study, a sponsor faced several challenges related to resource allocation and...

FSP models for IVD Clinical Trials: Meeting Growing Pipeline Demands

Streamlining Clinical Trial Operations: How the FSP Model Transformed a Mid-Sized Biotech Company's Success. In this case study, we delve into the experience of a mid-sized genetic testing and...

Global Footprint

US and Canada UK Europe Asia Pacific

North America

United Kingdom

Europe

Asia Pacific

Raleigh (HQ)

107 West Hargett St.
Raleigh, NC 27601

1-888-242-0559

Bozeman

274 Discovery Dr, Suite 100 Bozeman, MT 59718

1-888-242-0559

Chicago (Deerfield)

10 Parkway North, Suite 310
Deerfield, IL 60015

1-888-242-0559

Chicago (Loop)

200 N. Lasalle Street, Suite 2450
Chicago, IL 60601

1-888-242-0559

Washington, DC

1129 20th St NW, Suite 600
Washington, DC 20036

1-202-833-8077

Windsor

3000 Temple Dr, Suite 200
Windsor, ON N8W 5J6

1-519-252-9555

London

John Stow House 18
Bevis Mark
London EC3A 7JB

+44 (0)1748 828800

North Yorkshire

Olliver, Aske, Richmond
North Yorkshire, DL10 5HX

+44 (0)1748 828800

Berlin

Siemensdamm 62
13627 Berlin

+49 (0) 30 85606878 - 0

Leiden

Schipholweg 59
2316 ZL Leiden

+31 (0) 71 52440 00

Lund

Medicon Village
223 81 LUND

+46 (0) 8-560 020 33

Stockholm

Fleminggatan 18
SE -112 26 Stockholm

+46 (0) 8 21 5445

Zagreb

Ulica grada Vukovara 269a, 10000 Zagreb, Croatia

+385 1 2396 900

Sarajevo

Alipašina 29, 71000 Sarajevo, Bosnia and Herzegovina

Belgrade (Main)

Beogradskog Bataljona 4, 11000 Belgrade, Serbia

+381 11 3695 068

Belgrade

Nedeljka Čabrinovića 65, 11000 Belgrade, Serbia

Podgorica

Bul. Svetoga Petra Cetinjskog 114/I, 81000 Podgorica, Crna Gora

Skopje

Ul. Arso Mickov 29, 1060 Skopje, Macedonia

+389 2 5210 656

Skopje (Office)

st. Fjodor Dostoevski no. 72 (Industrila zone Karpos area Vlae), Skopje

Brasov

Saturn Boulevard no. 42/A 3rd floor, Ap. 13, 500164 Brasov, Romania

Tbilisi

Shartava Street, # 40, Tbilisi, Georgia

Tirana

Rruga Xhanfize Keko Nr. 56, Njesia Administrative 12, H 2, Z. 505, Tirana, Albania.

Melbourne

Suite 6, Ground Level
452 Johnston Street
Abbotsford, VIC 3067

+61 3 8814 7900

Hyderabad

3rd Block, 7th Floor,
My Home Hub, Madhapur, Patrika Nagar, HITEC City,
Hyderabad, Telangana 500081

+91 966 611 1980

Tokyo

16F Link Square Shinjuku
5-27-5 Sendagaya, Shibuya-ku, Tokyo, 151-0051
Japan

+81 3 6277 4041

Makati City

7th Floor Office F
Armstrong Corporate Center
HV Dela Costa Ave.
Salcedo Village
Makati City

+61 38814 7900

Shanghai

Room 04N162, 4/F, Annex
No. 138 Huaihai Middle Road
Huangpu District
Shanghai

+61 38814 7900

Global Footprint

US and Canada

Down arrow - click here to expand section.

Raleigh (HQ)

107 West Hargett St.
Raleigh, NC 27601

1-888-242-0559

Bozeman

274 Discovery Dr, Suite 100 Bozeman, MT 59718

1-888-242-0559

Chicago (Deerfield)

10 Parkway North, Suite 310
Deerfield, IL 60015

1-888-242-0559

Chicago (Loop)

200 N. Lasalle Street, Suite 2450
Chicago, IL 60601

1-888-242-0559

Washington, DC

1129 20th St NW, Suite 600
Washington, DC 20036

1-202-833-8077

Windsor

3000 Temple Dr, Suite 200
Windsor, ON N8W 5J6

1-519-252-9555

UK

Down arrow - click here to expand section.

London

John Stow House 18
Bevis Mark
London EC3A 7JB

+44 (0)1748 828800

North Yorkshire

Olliver, Aske, Richmond
North Yorkshire, DL10 5HX

+44 (0)1748 828800

Europe

Down arrow - click here to expand section.

Berlin

Siemensdamm 62
13627 Berlin

+49 (0) 30 85606878 - 0

Leiden

Schipholweg 59
2316 ZL Leiden

+31 (0) 71 52440 00

Lund

Medicon Village
223 81 LUND

+46 (0) 8-560 020 33

Stockholm

Fleminggatan 18
SE -112 26 Stockholm

+46 (0) 8 21 5445

Zagreb

Ulica grada Vukovara 269a, 10000 Zagreb, Croatia

+385 1 2396 900

Sarajevo

Alipašina 29, 71000 Sarajevo, Bosnia and Herzegovina

Belgrade (Main)

Beogradskog Bataljona 4, 11000 Belgrade, Serbia

+381 11 3695 068

Belgrade

Nedeljka Čabrinovića 65, 11000 Belgrade, Serbia

Podgorica

Bul. Svetoga Petra Cetinjskog 114/I, 81000 Podgorica, Crna Gora

Skopje

Ul. Arso Mickov 29, 1060 Skopje, Macedonia

+389 2 5210 656

Skopje (Office)

st. Fjodor Dostoevski no. 72 (Industrila zone Karpos area Vlae), Skopje

Brasov

Saturn Boulevard no. 42/A 3rd floor, Ap. 13, 500164 Brasov, Romania

Tbilisi

Shartava Street, # 40, Tbilisi, Georgia

Tirana

Rruga Xhanfize Keko Nr. 56, Njesia Administrative 12, H 2, Z. 505, Tirana, Albania.

Asia Pacific

Down arrow - click here to expand section.

Melbourne

Suite 6, Ground Level
452 Johnston Street
Abbotsford, VIC 3067

+61 3 8814 7900

Hyderabad

3rd Block, 7th Floor,
My Home Hub, Madhapur, Patrika Nagar, HITEC City,
Hyderabad, Telangana 500081

+91 966 611 1980

Tokyo

16F Link Square Shinjuku
5-27-5 Sendagaya, Shibuya-ku, Tokyo, 151-0051
Japan

+81 3 6277 4041

Makati City

7th Floor Office F
Armstrong Corporate Center
HV Dela Costa Ave.
Salcedo Village
Makati City

+61 38814 7900

Shanghai

Room 04N162, 4/F, Annex
No. 138 Huaihai Middle Road
Huangpu District
Shanghai

+61 38814 7900

News & Insights

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Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Companies: A Tale of Two Paths

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September 9, 2025

FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?

FDA will now release Complete Response Letters in real time. Learn what this transparency means for drug developers, investors, and the industry.

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ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Guide Your Roadmap to European Drug Approval: The Complete Solution - ProPharma

September 9, 2025

Your Roadmap to European Drug Approval: The Complete Solution

Discover how ProPharma simplifies the complex journey to European drug approval by acting as a full-service Marketing Authorization Holder partner. From crafting regulatory strategies and...

Whitepapers Agility Meets Expertise: The ProPharma FSP Approach - ProPharma

September 3, 2025

Agility Meets Expertise: The ProPharma FSP Approach

Discover how ProPharma elevated the Functional Service Provider (FSP) Model by blending specialized expertise, agile resourcing, and innovative technology. By building dedicated teams, streamlining...

Case Study From Local Limits to Global Integration: Transforming Medical Information Services in Japan - ProPharma

August 21, 2025

From Local Limits to Global Integration: Transforming Medical Information Servic...

Discover how ProPharma transformed medical information services in Japan by integrating global alignment with localized expertise. By harmonizing processes, cross-training teams, and tailoring...

AI in Medical Information: Who Holds the Responsibility?

October 16, 2025

AI in Medical Information: Who Holds the Responsibility?

In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what...

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

September 23, 2025

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...

The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

September 17, 2025

The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

In today’s data-driven R&D environment, fragmented and incompatible data can stall innovation. This webinar, led by experts from ProPharma and CSL Behring, reveals how robust data standards,...

News & Insights

FDA Launches Crackdown on Deceptive Drug Advertising

September 10, 2025

FDA Launches Crackdown on Deceptive Drug Advertising

FDA’s new crackdown on deceptive drug advertising reshapes pharma marketing. Discover implications for sponsors, compliance strategies, and patient trust.

Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Companies: A Tale of Two Paths

September 10, 2025

Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Co...

Discover two distinct paths for creating a global audit strategy in medical device companies, focusing on harmonization and compliance efficiency ahead of FDA's 2026 QMSR changes.

FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?

September 9, 2025

FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?

FDA will now release Complete Response Letters in real time. Learn what this transparency means for drug developers, investors, and the industry.

Previous Post Arrow Next Post Arrow
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review

July 8, 2025

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...

ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

Previous Post Arrow Next Post Arrow
ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Previous Award Arrow Next Award Arrow
Guide Your Roadmap to European Drug Approval: The Complete Solution - ProPharma

September 9, 2025

Your Roadmap to European Drug Approval: The Complete Solution

Discover how ProPharma simplifies the complex journey to European drug approval by acting as a full-service Marketing Authorization Holder partner. From crafting regulatory strategies and...

Whitepapers Agility Meets Expertise: The ProPharma FSP Approach - ProPharma

September 3, 2025

Agility Meets Expertise: The ProPharma FSP Approach

Discover how ProPharma elevated the Functional Service Provider (FSP) Model by blending specialized expertise, agile resourcing, and innovative technology. By building dedicated teams, streamlining...

Case Study From Local Limits to Global Integration: Transforming Medical Information Services in Japan - ProPharma

August 21, 2025

From Local Limits to Global Integration: Transforming Medical Information Servic...

Discover how ProPharma transformed medical information services in Japan by integrating global alignment with localized expertise. By harmonizing processes, cross-training teams, and tailoring...

Previous Resource Arrow Next Resource Arrow
AI in Medical Information: Who Holds the Responsibility?

October 16, 2025

AI in Medical Information: Who Holds the Responsibility?

In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what...

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

September 23, 2025

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...

The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

September 17, 2025

The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

In today’s data-driven R&D environment, fragmented and incompatible data can stall innovation. This webinar, led by experts from ProPharma and CSL Behring, reveals how robust data standards,...

Previous Webinar Arrow Next Webinar Arrow