therapeutic areas 

Global domain expertise across an extensive range of therapeutic areas.

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Best-in-class project teams

Our teams will be assembled to match the therapeutic requirements for your clinical trials. We focus on providing clinical trial solutions that will deliver your studies with responsiveness, flexibility, and a personalized approach. 

Therapeutic Areas of Focus

Our team of experts has decades of experience across a wide variety of therapeutic areas. We work as an extension of your team, bringing you immediate resources who will align with your processes and environment. By partnering with ProPharma, you can leverage our clinical trial execution capabilities with responsiveness, flexibility, and a personalized approach.

 

Oncology

ProPharma has a unique combination of experience across the oncology trial space. We have supported clinical studies across a variety of malignancies in both the pediatric and adult patient populations. Our teams have supported radiolabeled studies and understand the unique complexities and regulations involved with delivering this type of study. Our established site relationships and site network allows our teams to support fast study set up and site activation to meet your most challenging goals.

Explore Oncology CRO Solutions

Cardiovascular

ProPharma’s cardiovascular research team has supported clinical trials across a variety of cardiac diseases in both adult and pediatric patient populations. We understand the challenges that come with delivering this type of study for both drug and medical device and diagnostics.

Cell and Gene Therapy

Our Cell and Gene Therapy Center of Excellence helps clients around the world accelerate their novel, advanced therapeutic products to market. We have cell and gene therapy (CAGT) experts that have supported more than 100 different CAGT development programs.

ProPharma’s CAGT consulting team has a combined 25 years of experience delivering unique lifesaving treatments to market in EU, US, and Japanese regulatory environments. Our diverse talent pool supports you across the full development lifecycle to bring products effectively and efficiently to patients.

Explore our Cell and Gene Therapy Consulting Services

CNS (Central Nervous System)

With many unmet needs across a myriad of conditions affecting the central nervous system (CNS), every step forward can have a monumental impact on a patient’s health and everyday activities. Armed with experience in a broad range of indications, we can confidently guide you to your neuroscience discovery.

Infectious Diseases and Vaccines

With the fast pace of infectious disease and vaccine trials, our experienced team knows how to ensure the global scale and intellectual property (IP) logistics are in place to allow for accelerated enrollment. We’ve supported a wide variety of global vaccine trials across adult and patient populations, including COVID-19.

Medical Technology

ProPharma’s Medical Technology team knows and understands device and diagnostics regulations, and our staff has experience with the regulatory process for clinical trial and product approval in the US and EU. Our clinical team understands the regulatory implications of its actions and decisions, so you can rest assured your clinical study or regulatory submission is in expert hands.

Explore our Medical Technology

Ophthalmology

Our team understands the unique challenges that ophthalmology clinical trials face, such as requiring special imaging vendors and incorporating cell and gene therapy. Our experts know how to design and execute these types of trials efficiently to help accelerate your path to approval.

Pediatrics

Our multidisciplinary clinical team can create a purposeful strategy to navigate the challenges and risk mitigation strategies associated with pediatric studies. With an awareness of the global pediatric landscape, our team can assist in consent/assent, protocol development, and study design. Our cross-functional teams can support the development process including regulatory strategy, protocol development, execution, and regulatory filing.

Rare / Orphan Diseases

In the rare disease space, patients and their families are faced with a lack of available therapies and huge unmet needs. We understand the challenges these patients endure and reducing their burden is our focus. Our cross-functional team of rare disease experts can leverage in-depth experience to navigate the complexity of developing these therapies while having small patient populations and regulatory obstacles at the forefront of the assigned teams.

Respiratory

We have strong experience in many of the unique aspects that define early clinical research with respiratory and inhaled drug products. We help our customers navigate the complex challenges of respiratory clinical trials through our experienced clinical development team.

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...

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...

Company News Press Releases Innovation and the Black Swan Prodigy Whitepaper

January 4, 2024

Innovation and the Black Swan Prodigy Whitepaper

Check out our comprehensive whitepaper, "Innovation and the Black Swan: the Imperative of AI-enabled clinical research," for an in-depth look at how embracing AI-enabled tools and technologies is...

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

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...

Company News Press Releases Innovation and the Black Swan Prodigy Whitepaper

January 4, 2024

Innovation and the Black Swan Prodigy Whitepaper

Check out our comprehensive whitepaper, "Innovation and the Black Swan: the Imperative of AI-enabled clinical research," for an in-depth look at how embracing AI-enabled tools and technologies is...

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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

Where Bespoke Strategy Meets Therapeutic Expertise

The complex needs for specific therapeutic areas requires leaders in their fields. The standard model doesn’t fit that level of specificity. Our global reach powers the insights and customized strategy that are the key to your success.