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clinical development

Advisory and execution services to efficiently advance new drugs and devices to market

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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, 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
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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.


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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.

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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.

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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.)

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News & Insights

Meet the Expert Meet the Expert: Collin Freeman

May 25, 2023

Meet the Expert: Collin Freeman

  Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Meet the Expert Meet the Expert: Tiffany Rice

May 18, 2023

Meet the Expert: Tiffany Rice

    Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Meet the Expert Meet the Expert: Alexis O'temro

May 11, 2023

Meet the Expert: Alexis O'temro

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Press Releases ProPharma Announces the Appointment of Dr. Ronald Freeze, Ph.D., as Global Head of Medical Technology

May 17, 2023

ProPharma Announces the Appointment of Dr. Ronald Freeze, Ph.D., as Global Head of Medical Technology

RALEIGH, NC, May 17, 2023, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of Odyssey...

Press Releases ProPharma Announces Strategic Partnership with H1 to Optimize R&D with AI, Data Insights and Analytics

May 9, 2023

ProPharma Announces Strategic Partnership with H1 to Optimize R&D with AI, Data Insights and Analytics

RALEIGH, NC, May 9, 2023, ProPharma Group (ProPharma), the world’s largest Research Consulting Organization (RCO) and a portfolio company of Odyssey Investment Partners, and H1, a leading healthcare...

Press Releases EY Announces Michael Stomberg as an Entrepreneur Of The Year® 2023 Midwest Award Finalist

May 1, 2023

EY Announces Michael Stomberg as an Entrepreneur Of The Year® 2023 Midwest Award Finalist

Entrepreneur Of The Year celebrates ambitious entrepreneurs who are building bolder futures   RALEIGH, NC, May 1, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

May 3, 2022

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric Approach to Clinical Research Solutions ProPharma Group is honored to be named Top 10 CRO 2022 by Pharma Tech Outlook...

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

April 21, 2022

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...

Congratulations to our 2015 Colleague Award Winners!

December 21, 2015

Congratulations to our 2015 Colleague Award Winners!

Each and every year, it continues to be a company tradition that we take a moment to recognize a select few ProPharma Group colleagues who made a special impact on our company and our clients...

News & Insights

Press Releases ProPharma Announces the Appointment of Dr. Ronald Freeze, Ph.D., as Global Head of Medical Technology

May 17, 2023

ProPharma Announces the Appointment of Dr. Ronald Freeze, Ph.D., as Global Head of Medical Technology

RALEIGH, NC, May 17, 2023, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of Odyssey...

Press Releases ProPharma Announces Strategic Partnership with H1 to Optimize R&D with AI, Data Insights and Analytics

May 09, 2023

ProPharma Announces Strategic Partnership with H1 to Optimize R&D with AI, Data Insights and Analytics

RALEIGH, NC, May 9, 2023, ProPharma Group (ProPharma), the world’s largest Research Consulting Organization (RCO) and a portfolio company of Odyssey Investment Partners, and H1, a leading healthcare...

Press Releases EY Announces Michael Stomberg as an Entrepreneur Of The Year® 2023 Midwest Award Finalist

May 01, 2023

EY Announces Michael Stomberg as an Entrepreneur Of The Year® 2023 Midwest Award Finalist

Entrepreneur Of The Year celebrates ambitious entrepreneurs who are building bolder futures   RALEIGH, NC, May 1, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

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ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

May 03, 2022

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric Approach to Clinical Research Solutions ProPharma Group is honored to be named Top 10 CRO 2022 by Pharma Tech Outlook...

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

April 21, 2022

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...

Congratulations to our 2015 Colleague Award Winners!

December 20, 2015

Congratulations to our 2015 Colleague Award Winners!

Each and every year, it continues to be a company tradition that we take a moment to recognize a select few ProPharma Group colleagues who made a special impact on our company and our clients...

Previous Award Arrow Next Award Arrow
Meet the Expert Meet the Expert: Collin Freeman

May 25, 2023 7:00:00 AM

Meet the Expert: Collin Freeman

  Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Meet the Expert Meet the Expert: Tiffany Rice

May 18, 2023 7:00:00 AM

Meet the Expert: Tiffany Rice

    Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Meet the Expert Meet the Expert: Alexis O'temro

May 11, 2023 7:00:00 AM

Meet the Expert: Alexis O'temro

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

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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.