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.

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.

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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

United States 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

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

138 HuaiHai Zhong Lu
3F
Huangpu District
Shanghai

+61 38814 7900

Global Footprint

United States

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

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

138 HuaiHai Zhong Lu
3F
Huangpu District
Shanghai

+61 38814 7900

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ProPharma Receives 2024 CPHI Regulatory and Compliance Award

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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

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News & Insights

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 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.

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
Navigating FDA's Q-Submission Process: A Strategic Advantage for Medical Device Developers

June 10, 2025

Navigating FDA's Q-Submission Process: A Strategic Advantage for Medical Device Developers

Learn how FDA’s Q-Submission process, especially Pre-Subs, offers a strategic advantage for medical device developers seeking regulatory clarity and approval.

From Discovery to Discontinuation: How Medical Information Supports Every Stage

June 6, 2025

From Discovery to Discontinuation: How Medical Information Supports Every Stage

Explore how MI services support every stage of pharmaceutical product development, from discovery to post-marketing, ensuring safety and compliance.

Technology Transfer Projects: Assessing Need and Readiness

June 5, 2025

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Learn how to determine the need and readiness for leading your own Technology Transfer projects to ensure efficiency and success in your manufacturing processes.

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow