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.

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

Meet the Expert: David Lough

June 19, 2024

Meet the Expert: David Lough

Meet the Expert: David Lough, a Senior Pharmacovigilance Consultant at ProPharma, shares insights on PSMF and robust quality management systems.

An Overview of the PSMF: Pharmacovigilance System Master File

June 17, 2024

An Overview of the PSMF: Pharmacovigilance System Master File

Learn about the Pharmacovigilance System Master File (PSMF) in the EU, its history, structure, updates, and outsourcing options.

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

June 13, 2024

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

Read ProPharma's essential guide to the Graduated Plan Officer (GPO), outlining requirements, responsibilities, and local registration processes.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

May 2, 2024

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

ProPharma and PBL introduce Cell Factory Box for decentralized Cell & Gene Therapies manufacturing, reducing costs and improving patient access to life-saving treatments.

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

April 18, 2024

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

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

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

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

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

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

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

May 2, 2024

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

ProPharma and PBL introduce Cell Factory Box for decentralized Cell & Gene Therapies manufacturing, reducing costs and improving patient access to life-saving treatments.

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

April 18, 2024

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

Previous Post Arrow Next Post Arrow
ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

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

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

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

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

Previous Award Arrow Next Award Arrow
Meet the Expert: David Lough

June 19, 2024

Meet the Expert: David Lough

Meet the Expert: David Lough, a Senior Pharmacovigilance Consultant at ProPharma, shares insights on PSMF and robust quality management systems.

An Overview of the PSMF: Pharmacovigilance System Master File

June 17, 2024

An Overview of the PSMF: Pharmacovigilance System Master File

Learn about the Pharmacovigilance System Master File (PSMF) in the EU, its history, structure, updates, and outsourcing options.

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

June 13, 2024

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

Read ProPharma's essential guide to the Graduated Plan Officer (GPO), outlining requirements, responsibilities, and local registration 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

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.