clinical development
Advisory and execution services to efficiently advance new drugs and devices to market
Expert support for the Design and Execution of Clinical Trials
Used to define the end-to-end process of bringing a new drug or device to market, Clinical Development includes discovery and product development, preclinical 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
RCO - Clinical Development
We support our clients by bringing targeted Subject Matter Experts (SMEs) to consult and advise on strategy, build the most efficient solution, and continuously support the product lifecycle. From Phase I through IV, ProPharma provides advisory and execution services to efficiently advance new drugs and devices to market safely and efficiently. Our RCO model leads with strategy to de-risk programs and tailor clinical development solutions to maximize success rates while keeping costs down.
Accelerated Proof-of-Concept
Accelerated 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 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. Our early development operating model is focused on accelerating proof-of-concept studies to arrive at an earlier go-no-go decision and accelerated value inflection.
Early Phase / Phase I Development
Our clinical development and regulatory experts work in tandem to advise, design, and execute first-in- human studies for our clients. We will work with you to optimize clinical trial design, implement patient- centric approaches, and guide you through the entire clinical development lifecycle. Our team of experts can help in the early-phase clinical development services specifically engineered to accelerate study progression. Our clinical operations team will successfully lead and execute your proof-of-concept study to Phase 2 trial ensuring a streamlined approach and a seamless transition.
No matter where you are in the clinical development process, our clinical operations team can help. At each phase of clinical trials, we will provide expert guidance to lead you to the next phase and ultimately a successful outcome with the appropriate regulatory agency.
Trial Design & Management
ProPharma’s full-service clinical trial design and clinical trial management services help craft the path to successfully navigate from phase to phase. Leading with strategy, our clinical trial teams are experienced and adaptive to the rigorous requirements of regulatory authorities.
We partner with your team and efficiently collaborate to design trials that fit your needs. Our clinical operations teams have the experience to ensure high quality and validated GxP compliant clinical trial management systems (CTMS) to store, analyze, and produce the necessary outputs to prepare your product for the next step.
Confirmatory Phase IIb-III Studies
Confirmatory phase IIb-3 studies are a part of the late-stage clinical development and are a critical stage that determines the efficacy and safety of the product. ProPharma has the capabilities, experience, and global presence to ensure sufficient evidence of safety and efficacy in filings with your local regulatory authority. To move you to the next clinical trial phase, ProPharma will diligently work with you to build an optimal submission strategy to move you to Phase 3.
Navigate Late-Stage Hurdles with Seasoned Guidance
We customize solutions using our comprehensive lineup of clinical operations services and a select team that understands your needs. Whether tackling the issue of an under-resourced company infrastructure or working on a novel therapy or trial design, ProPharma’s Clinical Development team will get it done effectively and efficiently.)
News & Insights
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...
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...
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...
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...
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...
January 4, 2024
ProPharma Unveils Prodigy: Groundbreaking Technology-Enabled Consulting Platform to Revolutionize Life Science Consulting Industry
Whitepaper published alongside today's announcement details $5M+ investment and up to 50% improvement in speed, quality, and cost with new AI-enhanced solutions. RALEIGH, NC, January 4, 2023 –...
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,...
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...
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...
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...
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...
News & Insights
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...
January 4, 2024
ProPharma Unveils Prodigy: Groundbreaking Technology-Enabled Consulting Platform to Revolutionize Life Science Consulting Industry
Whitepaper published alongside today's announcement details $5M+ investment and up to 50% improvement in speed, quality, and cost with new AI-enhanced solutions. RALEIGH, NC, January 4, 2023 –...
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,...
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...
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...
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...
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...
Complex Needs Require Custom Solutions
ProPharma builds solutions at the intersection of innovation and flexibility. We’re here to offer a custom alternative that fits your unique needs. Standout solutions scaled to your size.