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, 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
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

December 6, 2023
Meet the Expert: Clarence Young
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...

November 27, 2023
Key Steps to Creating a Successful Market Access Strategy
Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...

November 20, 2023
The Hidden Costs of Project Communication Gaps
Ineffective communication may be a key factor contributing to the challenges in your projects. Communication is a vital aspect of our daily lives, and the success of a project is closely linked to...

December 6, 2023
ProPharma Expands into Central and Eastern Europe Through Acquisition of Clinres Farmacija
RALEIGH, NC, December 6, 2023 – ProPharma Group (ProPharma), the world’s largest Research Consulting Organization (RCO) and the leading global provider of regulatory, clinical and compliance services...

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...

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...

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...

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

December 06, 2023
ProPharma Expands into Central and Eastern Europe Through Acquisition of Clinres Farmacija
RALEIGH, NC, December 6, 2023 – ProPharma Group (ProPharma), the world’s largest Research Consulting Organization (RCO) and the leading global provider of regulatory, clinical and compliance services...

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...

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...

Nov 27, 2023 7:00:00 AM
Key Steps to Creating a Successful Market Access Strategy
Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...

Nov 20, 2023 7:00:00 AM
The Hidden Costs of Project Communication Gaps
Ineffective communication may be a key factor contributing to the challenges in your projects. Communication is a vital aspect of our daily lives, and the success of a project is closely linked to...

October 14, 2021
Accelerate European Market Access with Compliant and Comprehensive MAA Submission
Preparedness for Marketing Authorization Application (MAA) approval ensures an efficient application process and follow-up. Placing a medicinal product in the European market requires a license for...

March 18, 2022
Outsourcing QA - Reduce Time and Expense While Meeting Critical Requirements
There is a tendency for VPCs to rely solely on the QC/QA units within their outsourced CMO to perform quality functions. However, the sponsor organization has the ultimate responsibility for product...

October 14, 2021
Dedicated Project Manager Directs Regulatory Activities Throughout European Economic Area
Learn how a single point of contact oversaw local regulatory affairs activities across all 31 countries of the EEA. You’re developing a drug, biologic, or medical device product. There are a lot of...

September 1, 2022
Webinar: AI-Powered MI Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability
Today's Medical Information (MI) industry is being driven by evolving customer behavior requiring a more rapid, omnichannel, and digital response to customer needs. The expectation for higher...

October 14, 2021
Ensure Successful Acquisitions with Complete and Accurate Regulatory Due Diligence
Ensure you have as much information as possible to thoroughly evaluate the potential investment when acquiring a company or product. When considering the acquisition of a new company or product, it...

October 14, 2021
Ensure Successful Batch Release, Regulatory Compliance with Experienced Qualified Persons
Streamlining a CMO’s manufacturing process helped ensure GMP compliance for EU batch release and USA inspection readiness. A contract manufacturing organization (CMO) needs to have a reliable quality...

October 4, 2021
How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach
A global biopharmaceutical client with multiple sites operating under a Warning Letter from the U.S. Food and Drug Administration (FDA) needed significant cross-functional support to meet remediation...

October 14, 2021
Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline
Risk evaluation of products containing chemically synthesized APIs must be done to assess adherence to nitrosamine regulations. Marketing Authorization Holders (MAHs) must perform a risk evaluation...

October 4, 2021
Increased Visibility for Senior Management with Custom PMO Design, Implementation
Time. Regardless of company size and the number of products in your portfolio, time is one thing we could all use more of. However, the more projects you have in your portfolio, the more stretched...

October 14, 2021
Initiating Enrollment for Accelerated COVID-19 Treatment Studies in 6 Days
In May 2020, as the FDA released new guidelines to accelerate the development of novel COVID-19 therapeutics and vaccines, our Clinical Services experts were asked to provide independent Data Safety...

October 14, 2021
MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction
A routine safety letter to healthcare professionals (HCPs) was misinterpreted by recipients, causing a “recall-like” crisis event for a multinational pharmaceutical client. When a routine safety...

December 7, 2023
Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life
In the competitive and fast-moving Cell and Gene Therapy (CGT) field, developers face a range of scientific, technical, and regulatory challenges that can quickly become overwhelming and costly. In...

May 19, 2022
Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective
As businesses face the shared global challenges of adapting to new operating models triggered by the recent pandemic, regulated drug and device sponsors, marketing authorization holders, and...

March 25, 2022
Insider Talks - To Decentralize or Not to Decentralize … That is the Question
Having a decentralized approach is critical to ensuring continuity in the face of disaster, and important in meeting your overall enrollment goals while increasing patient diversity. Join us for our...

October 14, 2021
Secure Timely Product Launch by Ensuring GDP Compliance Across Europe
Our client was in the phase of submitting a Marketing Authorization Application (MAA) in the EU and needed to apply for a Wholesale Distribution Authorization (WDA). After application and approval of...

October 14, 2021
Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors
Managing and sharing large amounts of clinical data provided by a team of ten plus vendors is extremely challenging and requires meticulous attention to detail and expert-level project management to...

October 14, 2021
Understanding Clinical Trial Requirements for Medical Device Label Extensions
After you have developed an FDA-regulated product and obtained marketing approval, you may think your job is done. However, after all the time, effort, money, and so much more that goes into product...

October 17, 2021
Outsourcing of Medical Information Content Creation: Experience of 100 Clients
The time and effort required to write, review, edit, approve, maintain, distribute, and update Medical Information (MI) documents while retaining an auditable record of the search strategy is a great...

October 4, 2021
Outsourcing Medical Information Services: When to Consider a Dedicated Resource
Outsourcing Medical Information (MI) services can be an effective solution for ensuring the provision of MI services to HCPs and consumers globally. The most cost-effective model for the provision of...

May 3, 2023
Improve Quality & Consistency by Leveraging AI for Trial Master File Classification
Improve Quality and Consistency by Leveraging AI for Trial Master File Classification The whitepaper "Improve Quality and Consistency by Leveraging AI for Trial Master File Classification" addresses...
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.