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.

 

Obesity & Diabetes

The obesity drug market is rapidly expanding, fueled by the success of innovative treatments. With an increasing number of pharmaceutical companies, particularly smaller and mid-sized firms, aiming to make an impact in this evolving field, the demand for expertly managed clinical trials is more crucial than ever. ProPharma provides specialized services to guide you through the complexities of obesity clinical trials, ensuring your study not only contributes to scientific advancements but also delivers effective treatments to the patients who need them most.

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.

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.

MedTech

ProPharma’s MedTech 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 MedTech

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

Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market

July 28, 2025

Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market

Learn about PADER, a crucial pharmacovigilance requirement for U.S. drug safety monitoring, and how it differs from PSUR in ensuring compliance and patient safety. Summarizing the main point of the...

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)

July 25, 2025

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...

Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).

FDA Publishes over 200 Complete Response Letters (CRLs)

July 24, 2025

FDA Publishes over 200 Complete Response Letters (CRLs)

FDA's new transparency with over 200 CRLs empowers sponsors to navigate regulatory challenges more effectively, accelerating drug approvals and enhancing patient access to treatments.

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.

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.

Case Study Successfully Executing a Tech Transfer in a Week - ProPharma

July 29, 2025

Successfully Executing a Tech Transfer in a Week

Discover how ProPharma supported a $3B pharmaceutical tech transfer that was executed in just 3 days, relocating five complex product lines. The plan included FDA alignment, pre-approved protocols,...

Case Study Obesity – Accelerated Timelines - ProPharma

July 29, 2025

Obesity – Accelerated Timelines

A mid-size biotech needed fast U.S. market entry for an obesity trial. ProPharma activated 20 sites in 30 days and enrolled 300+ patients—meeting goals despite an increased sample size. Strategic...

Whitepapers Key Compliance Challenges in U.S. Medical Information Services - ProPharma

July 29, 2025

Key Compliance Challenges in U.S. Medical Information Services

For Medical Information (MI) teams navigating today’s evolving regulatory landscape, compliance isn’t just a requirement — it’s a strategic imperative. From managing off-label inquiries to...

Avoiding Common Pitfalls During FDA Inspections

July 29, 2025

Avoiding Common Pitfalls During FDA Inspections

Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

July 22, 2025

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...

MAH Essentials: Ensuring Compliance for European Market Entry

July 10, 2025

MAH Essentials: Ensuring Compliance for European Market Entry

This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...

News & Insights

Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market

July 28, 2025

Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market

Learn about PADER, a crucial pharmacovigilance requirement for U.S. drug safety monitoring, and how it differs from PSUR in ensuring compliance and patient safety. Summarizing the main point of the...

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)

July 25, 2025

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...

Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).

FDA Publishes over 200 Complete Response Letters (CRLs)

July 24, 2025

FDA Publishes over 200 Complete Response Letters (CRLs)

FDA's new transparency with over 200 CRLs empowers sponsors to navigate regulatory challenges more effectively, accelerating drug approvals and enhancing patient access to treatments.

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
Case Study Successfully Executing a Tech Transfer in a Week - ProPharma

July 29, 2025

Successfully Executing a Tech Transfer in a Week

Discover how ProPharma supported a $3B pharmaceutical tech transfer that was executed in just 3 days, relocating five complex product lines. The plan included FDA alignment, pre-approved protocols,...

Case Study Obesity – Accelerated Timelines - ProPharma

July 29, 2025

Obesity – Accelerated Timelines

A mid-size biotech needed fast U.S. market entry for an obesity trial. ProPharma activated 20 sites in 30 days and enrolled 300+ patients—meeting goals despite an increased sample size. Strategic...

Whitepapers Key Compliance Challenges in U.S. Medical Information Services - ProPharma

July 29, 2025

Key Compliance Challenges in U.S. Medical Information Services

For Medical Information (MI) teams navigating today’s evolving regulatory landscape, compliance isn’t just a requirement — it’s a strategic imperative. From managing off-label inquiries to...

Previous Resource Arrow Next Resource Arrow
Avoiding Common Pitfalls During FDA Inspections

July 29, 2025

Avoiding Common Pitfalls During FDA Inspections

Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

July 22, 2025

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...

MAH Essentials: Ensuring Compliance for European Market Entry

July 10, 2025

MAH Essentials: Ensuring Compliance for European Market Entry

This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...

Previous Webinar Arrow Next Webinar Arrow

Where Personalized Approach Meets Therapeutic Expertise

Meeting the demands of complex therapeutic areas requires expert guidance and a collaborative approach. With global reach and deep industry expertise, we provide personalized solutions and strategic insights, ensuring alignment with your goals every step of the way.