The World's Largest RCO
ProPharma offers a suite of fully customizable consulting solutions across service lines and functional areas of expertise. We collaborate with clients to co-create optimal solutions, build sustainable and scalable operating models, operationalize robust execution, and position our clients for development and growth.
Discovery and DevelopmentDelivering new drugs and therapies to market is a complex process that includes both discovery (target identification and validation, hit identification, lead generation & optimization, and identification of a viable candidate for future & further development) and development (optimization of chemical synthesis and formulation, toxicological studies, clinical trials, and regulatory approval) stages. ProPharma’s expertise spans across the following Discovery and Development competencies:
- Technology Transformation
- Research Platforms
- Target Identification
- Lead Validation
- Scientific Advisory and Regulatory
Pre-Clinical ResearchPrior to being used in a human, researchers perform initial drug testing in controlled laboratory settings. Results during this phase provide researchers with important information about the potential uses in humans, minimizing human exposure in early research. Although, it is almost never possible to eliminate risk entirely, risk management evaluation can be performed. ProPharma’s expertise spans across the following Pre-Clinical Research competencies:
- Translational/Pre-Clinical Work
- Lead Optimization
- IND/CTA Enabling Studies
- Program Design & Planning
Clinical DevelopmentUsed to define the end-to-end process of bringing a new drug or device to market, Clinical Development includes discovery and product development, pre-clinical research as well as clinical trials in people. ProPharma’s expertise spans across the following Clinical Development competencies:
- First-in-Human Studies
- Accelerated Proof of Concept
- Early Phase/Phase 1 Development
- Trial Design & Management
- Confirmatory Phase IIB – Phase III Studies
Health AuthorityNavigating health authority interactions and submissions across the globe is a complex process, requiring a science-focused approach to develop a plan, assess it to examine current performance with desired outcomes, and identify gaps between the information you have and what is needed for a successful submission. As an extension of your team, ProPharma’s experts ensure you have a comprehensive strategy that includes the following:
- Lifecycle Management
- Health Authority Interaction
- Regulatory Strategy
- Global Quality & Compliance
- Confirmatory Phase IIB – Phase III Studies
Post-Market MonitoringMonitoring and research don’t necessarily end with approval. Health authorities continue to monitor safety and performance after approval. ProPharma’s expertise spans across the following Post-Market Monitoring competencies:
- Market Development and Commercial Readiness
- Patient-Reported Safety & Outcomes
- Real-World Evidence
- Labeling & Promotional Review
- Risk Management Plans
Medical Device & DiagnosticsThe path for medical devices and diagnostics trials is different from drug development, which is why ProPharma has a dedicated team of experts who focus solely on supporting our device and diagnostics clients. Our experts understand what it takes to get these products to market and help design efficient and compliant trials to meet your goals. ProPharma’s experts ensure you have a comprehensive strategy that includes the following:
- In Vitro Diagnostics (IVD)
- Medical Device Product Development
- Clinical Evidence & Post-Market Studies
Select from a comprehensive array of full product lifecycle services to create a fit-for-purpose solution. These services by design, operate autonomously in a model that can be engaged individually to help with a specific need or assembled into an integrated end-to-end construct that can flex up or down in scope/scale as programs evolve. Our deep domain expertise helps you solve your most complex research problems across the following areas:
- Strategic Consulting
- R&D Information Technologies
- Biostatistics & Data Science
- Regulatory Sciences
- Rare Disease & Orphan R&D
- Cell & Gene Therapy
Our fit-for-purpose global solutions span across the full product life cycle with a team of experts who bring a comprehensive portfolio of services to help solve complex challenges in a dynamic environment. ProPharma’s global expertise includes:
- Clinical Research Services
- Regulatory Operations
- Medical Information
- Quality and Compliance
The Future of Research Consulting is Here
We’ve revolutionized the traditional model and put our clients at the very center. Our new system delivers better solutions and completely redefines what’s possible for you and your organization.
"The ProPharma Group has been a valued and trusted partner as our Medical Information third party call center for a number of years. During that time they have exhibited the highest level of quality, compliance, and professionalism. Always keeping the needs of our mutual customers front and center. The team is diverse in their staff and their offered services, which enables us to customize support to business need. We would highly recommend the services of ProPharma without hesitation.”
Laurie Wingett - Bayer, Inc.
Medical Affairs Head, Primary Care (WH/established brands) and Medical Operations
“Working with ProPharma has been a pleasure. The auditors are friendly, knowledgeable, and communicative. They have been a great resource to help us complete a wide range of audits and
manage our supplier quality.”
Emily King - Azurity Pharmaceuticals
"Working with the whole team at ProPharma Group has been an honor. For several years they have acted on our behalf as a trusted customer facing vendor for medical information inquiries. their subject matter expertise, collaborative nature and high level of professionalism have been a bellwether for us through all stages of marketing and scaling a new drug product. The next time my team is in need of scientific communication outsourcing, PPG will be my first stop."
Jenny Strauss - Biohaven Pharmaceuticals
Manager, Medical Information and Communications
“Lyell engaged ProPharma as our validation partner as we built and qualified the LyFE Manufacturing Center. ProPharma assisted in all phases of the qualification including establishing the facility and equipment qualification program, protocol generation, protocol execution, and writing the final reports. They played a critical role in getting the facility ready on time and on budget to support the Lyell clinical trials.”
David Shank - Lyell Immunopharma, Inc.
Vice President, Manufacturing
When we partnered with Oxford University to enable global development, manufacturing and distribution of our vaccine, we put broad and equitable access at the heart of our response. The result was a vaccine that was developed in under a year, and we believe we have made a significant impact in terms of global public health. Based on data published in The Lancet and an analysis by Airfinity, our vaccine is estimated to have saved over 6 million lives in the first year of vaccination.
AstraZeneca supplied the vaccine with no profit during the pandemic and we are supplying the vaccine with no profit in low-income countries today. To date, over 3 billion doses have been released for supply to more than 180 countries. AstraZeneca was the first and largest contributor in 2020 and 2021 to COVAX, with over 470 million doses. Doses that couldn’t have been released without the partnership with ProPharma. In our collaboration an estimated 500 million doses underwent thorough quality assessment to provide a vaccine made for the world.
Pythia Segers - Astra Zeneca
"We have had the pleasure of working with ProPharma on a global scale for several years assisting us with Medical Information Call Center and writing workflows. Their ability to adapt based on the client’s needs is very commendable. Also, we are fortunate to work with a very talented team of professionals who are always eager to work with us and deliver quality service to our customers."
News & Insights
News & Insights
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,...
November 16, 2023
ProPharma Launches an Integrated MedTech Organization Providing End-to-End Solutions for Innovators
Raleigh, NC, November 16, 2023: ProPharma Group, the world’s largest Research Consulting Organization (RCO) and the leading global provider of regulatory, clinical and quality compliance services for...
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...