Full Service CRO Solutions

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Our Approach

ProPharma focuses on a tailored operational model to improve quality and propel patient recruitment, including reaching diverse groups. Working together to craft the best strategy for you and your teams, we use technology, clinical data, and our global presence to make better decisions for safety, quality, and efficiency.

authority-meetings

Clinical Operations Experts

regulatory-cmc

Global Clinical Trial Management Teams

regulatory-sciences

Expertise Across All Study Phases and Therapeutic Areas 

qppv-office

Medical Monitoring Services

Our Approach

ProPharma focuses on a tailored operational model to improve quality and propel patient recruitment, including reaching diverse groups. Working together to craft the best strategy for you and your teams, we use technology, clinical data, and our global presence to make better decisions for safety, quality, and efficiency.

authority-meetings

Clinical Operations Experts

regulatory-cmc

Global Clinical Trial Management Teams

regulatory-sciences

Expertise Across All Study Phases and Therapeutic Areas 

qppv-office

Medical Monitoring Services


Industry-Leading Support for Multiphase Clinical Development and Study Execution

ProPharma is a global provider of patient-focused Clinical Research Solutions (CRS) to the pharmaceutical, biotechnology, and medical device and diagnostic industries. We are experts, with experience across all study phases and in a diverse and wide range of therapeutic areas. Our shared attributes of innovation, expertise, and passion are at the heart of everything we do.

Early Phase (Phase 1-2)

Quick completion of Phase 1-2 trials to meet proof of concept goals is critical. We provide clinical expertise and an extended suite of early phase clinical development services specifically engineered to accelerate study progression.

Our integrated regulatory, pharmacology, statistics, and clinical experts design protocols that address and generate the data you need to make go and no-go decisions.

Late Phase (Phase 3 and Beyond)

Late phase trials move your product from intended population testing to commercialization. We can develop and execute the global plans to move you forward – from reviewing and managing ongoing efficacy and safety data to generating real-world evidence to support pricing agreements. Our regulatory, clinical, and medical affairs experts know what you need. We are committed to delivering the strategy and market solutions you need to be successful.

Medical Device & Diagnositics

Late phase trials move your product from intended population testing to commercialization. We can develop and execute the global plans to move you forward – from reviewing and managing ongoing efficacy and safety data to generating real-world evidence to support pricing agreements. Our regulatory, clinical, and medical affairs experts know what you need. We are committed to delivering the strategy and market solutions you need to be successful.

 

Full Service CRO Solutions

  • Clinical Pharmacology Consulting Expertise
  • Regulatory Strategy, Operations, and Consulting
  • Clinical Operations Expertise:
    • Site Selection / Feasibility
    • Clinical Monitoring Services
    • eTMF and CTMS Support
    • Site Training
    • Study Conduct
    • Clinical Program and Project Management
    • Study Close

Get Expert Guidance for your Clinical Development Needs

As a full-service provider, ProPharma connects your clinical aspirations with our deep scientific and medical expertise, strong therapeutic insights, and unmatched clinical development experience to help you bring high-quality therapies to market fast – always with the patients’ safety in mind.

News & Insights

EU Regulatory Sciences EU Pharmaceutical Legislation Reform: Where Are We Now?

March 26, 2024

EU Pharmaceutical Legislation Reform: Where Are We Now?

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...

Medical Information Privacy PIPL China Understanding PIPL: Compliance and Implementation Challenges

March 25, 2024

Understanding PIPL: Compliance and Implementation Challenges

What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...

LPPV PSMF QPPV Pharmacovigilance Achieving Success with Regulatory Intelligence in Pharmacovigilance

March 25, 2024

Achieving Success with Regulatory Intelligence in Pharmacovigilance

What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...

R&D Technology Electronic Data Capture ProPharma Now Certified as Medidata Rave EDC Accredited Partner

April 18, 2024

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

Leading Research Consulting Organization (RCO) Receives Medidata Accreditation for the RAVE EDC Module, Enhancing Clinical Trial Efficiency and Data Integrity for sponsors. RALEIGH, April 18, 2024 –...

Press Releases ProPharma Announces Changes to Its Executive Leadership Team

April 10, 2024

ProPharma Announces Changes to Its Executive Leadership Team

Strategic Leadership Appointments to Propel Global Growth RALEIGH, April 10, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences...

Press Releases ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

January 24, 2024

ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...

Press Releases Awards EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

Press Releases Awards ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases Awards ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

August 15, 2023

ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...

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...

News & Insights

R&D Technology Electronic Data Capture ProPharma Now Certified as Medidata Rave EDC Accredited Partner

April 18, 2024

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

Leading Research Consulting Organization (RCO) Receives Medidata Accreditation for the RAVE EDC Module, Enhancing Clinical Trial Efficiency and Data Integrity for sponsors. RALEIGH, April 18, 2024 –...

Press Releases ProPharma Announces Changes to Its Executive Leadership Team

April 10, 2024

ProPharma Announces Changes to Its Executive Leadership Team

Strategic Leadership Appointments to Propel Global Growth RALEIGH, April 10, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences...

Press Releases ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

January 24, 2024

ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...

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Press Releases Awards EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

Press Releases Awards ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases Awards ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

August 15, 2023

ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...

Previous Award Arrow Next Award Arrow
EU Regulatory Sciences EU Pharmaceutical Legislation Reform: Where Are We Now?

March 26, 2024

EU Pharmaceutical Legislation Reform: Where Are We Now?

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...

Medical Information Privacy PIPL China Understanding PIPL: Compliance and Implementation Challenges

March 25, 2024

Understanding PIPL: Compliance and Implementation Challenges

What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...

LPPV PSMF QPPV Pharmacovigilance Achieving Success with Regulatory Intelligence in Pharmacovigilance

March 25, 2024

Achieving Success with Regulatory Intelligence in Pharmacovigilance

What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...

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