clinical research solutions

A global team of trusted experts for multi-phase clinical development.

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Leading Clinical Research Organization

Our team of clinical research experts brings depth and breadth of experience across all phases of clinical trials, applying proven techniques to provide innovative solutions. Regardless of where you are in the product lifecycle or what your clinical trial–related needs are, we offer clinical research solutions to efficiently bring your product to market. With decades of industry experience, our team of clinical research experts is current with the latest industry intelligence and ever-evolving regulations, making ProPharma the partner of choice when outsourcing your clinical trials.

All Clinical Research Solutions:

Our clinical research experts offer solutions to bring your product to market, regardless of where you are in your product’s lifecycle.

 

Full-Service CRO

The path to project success begins with choosing the right model and methodology to anticipate and manage the challenges that could arise during the lifecycle of a clinical trial. In response to more stringent regulations, globalization, and ever-changing technologies, ProPharma can build and tailor the optimal operational model to support consistent quality delivery and maximize participant recruitment and retention while expanding access to diverse populations. We will work with you to develop strategic, flexible approaches that leverage technology, clinical informatics, and our global reach to maximize data‑driven decision making that drives safety, quality, and efficiency.

global-clinical-trials-management-teams

Global Clinical Trial Management Teams

Global footprint, local expertise: we provide the flexibility you need in a rapidly evolving environment. Our experienced teams offer the footprint to meet your local clinical trial needs, with the confidence and agility to globalize when you are ready. Our global governance structure streamlines the complexity of multi-region studies.

Clinical Trials for Pharmaceuticals, Biologics, Medical Devices, and Diagnostics

With dedicated pharmaceutical, medical device, and diagnostics teams, ProPharma supports clinical trials in the most cutting-edge technologies, maintaining expertise in novel uses of less novel therapeutics, and repurposing products. We have internal SMEs including a Biologics Center of Excellence and create solutions to complex challenges.

Expertise Across All Study Phases and Therapeutic Areas / Specialties

Our teams work together to take you all the way through the development lifespan, from early pilot studies dose-ranging studies through pivotal registration studies. We focus on the patients, providing consistent delivery of the quality data you need.

Deep Functional Expertise

ProPharma’s Medical Writing teams create best-in-class quality documents to support all elements of your clinical trial needs, from protocol and consent forms, Investigator’s Brochures, clinical study reports, patient narratives, and CTD Module documents, to registering and disclosing clinical trial information on public registries and redacting documents to meet commercial transparency obligations while protecting patient and company confidentiality.

Our world-class Biostatistics and Data Management teams and programmers are adept at creating and managing quality design, build, and outputs. They will partner with you to ensure you achieve the most robust and successful outcomes, incorporating unique and adaptive designs where best suited.

Global pharmacovigilance specialists and medical monitors are here to support the safe implementation of your studies, and provide expert guidance, reporting, and DSMB management. We have a range of disease and therapy area experts to ensure you have the best, contemporary advice.

 

Explore Full-Service CRO

Functional Service Provider (FSP)

Clinical trials can be a costly drain on time and resources. Working with a quality FSP allows you to save on cost when outsourcing specific clinical services. This enables the project to reach completion faster while improving the overall quality of the work and driving efficiencies. As part of our FSP model, we provide functional expertise, resource management, and innovative solutions that are customized to meet the specific needs of our clients.

ProPharma offers a range of FSP models to fit all requirements, providing specific therapeutic area expertise, operational expertise, and integrated processes and systems, to ensure we map the right outsourcing approach to fit your project. We help our clients develop solutions that span clinical operations and clinical data sciences, as well as safety, nonclinical, and regulatory writing.

ProPharma provides all levels of support ranging from deploying a small group of experts within a function to supplementing an entire department of full-time equivalent staff. Our team of experts works as an extension of your team, bringing you immediate scalable resources who will align with your processes and environment. With our collaborative approach, we can provide strategic solutions that are built on a foundation of strong partnerships.

exceptional-quality

Exceptional Quality

By monitoring key metrics, checking for variations, evaluating enforcement trends, and investing in industry-leading expertise, we become your partner with measurable results. When you work with us, you get a high-caliber team that analyzes your KPIs to optimize your existing operational environment and develops tailor-made solutions that fill the gaps to create exceptional results.

Speed to Global Scale

Our industry-leading experts span across the United States and the Rest of World (ROW) to offer you a scalable network of professionals to execute your most complex and resource-dependent initiatives. ProPharma provides a flexible, dedicated, and global resource team that is scaled to accommodate your individual clinical trial needs.

Therapeutic Expertise

Our team consists of SMEs with varied backgrounds across the pharmaceutical, biotechnology, medical device, and diagnostic industries. With our deep-rooted expertise across countless therapeutic areas, we can anticipate obstacles and develop a strategy that fits our clients’ unique needs. Having a top-tier team of professionals allows our FSP infrastructure to move resources internally across clinical programs.

100% Dedicated Teams

We don’t just offer solutions; we tailor them to your needs with experts who are experienced across all phases of clinical development. At ProPharma, we know that a successful compound starts with the right team, and we’ll build it with you. Our FSP model is a Win-Win Functional solution because it fosters a partnership that brings together shared expertise & industry experience.

Time and Cost Efficiencies

The FSP model offers significant reduction in costs with greater potential to drive operational efficiencies over time. We enable companies to grow in infrastructure without the headcount burden & risks associated with HR costs & processes. Let ProPharma manage the administrative burden, so you can concentrate on the core tasks of the clinical trial, ensuring business continuity and driving efficiencies.

Decentralized Clinical Trials

Decentralized Clinical Trials (DCTs) are studies that are designed for study visits, procedures, and data collection to occur outside of the traditional site setting. DCTs revolve around the concept of patient centricity, with the goal of making participation easier and more convenient for the patient, ultimately creating a larger, more diverse population to test your drug or device while ensuring patient comfort and safety. The increased flexibility of DCTs expands the geographical reach, improves recruitment and retention, and enhances the patient experience while providing Sponsors with reliable data.

We support DCTs by providing the opportunity for study visits to take place in a location convenient to the patient, such as their home or office, supported by our team of employee GoClinical Clinicians who are trained in GCP and protocol-specific procedures. 

Home Visits

It can be overwhelming to determine how to deploy a decentralized approach, so incorporating home visits into your protocol is often a great place to start. ProPharma can support home visits as part of a hybrid or completely virtual trial design. Home visits allow for greater flexibility in your study design and reduce the burden of participation on the patient by designing processes that fit into the patient’s life, rather than asking the patient to fit their life into the trial. Allowing simple procedures to be performed in the patient’s home, also reduces the burden on the site by allowing site staff to focus on recruiting and enrolling patients and more complex procedures.

Employee Nursing Staff

ProPharma directly employs all GoClinical Clinicians (GCCs) to support your patients. Once hired, all GCCs are overseen by our Director of DCT Nursing and receive extensive training in GCP, IATA (Dangerous Goods), and protocol-specific procedures. This allows us to have direct oversight of all visits and ensures those visits are performed by known, high-quality clinicians with strong clinical skills and trial experience. GCCs are selected based on study requirements and range from phlebotomists, LPNs, and RNs. We are easily able to add GCCs based on location by leveraging extensive Global Talent Acquisition team and sister staffing companies, with over 25,000 qualified providers currently in our global database. Our approach reduces sponsor costs, removes unnecessary layers of vendor administration, and alleviates the challenges of finding providers with short notice through local home health agencies, significantly reducing the risk of missed visits.   

 

employee-nursing-staff

 

Proprietary eSource Technology

GoClinical, our proprietary, 21 CFR Part 11 and GDPR compliant eSource platform allows for the collection of source data from home visits and electronically sends data for entry into the EDC. All source forms are designed per study to mirror the CRF and act as a guide for our GCCs performing home visits. This approach to source collection significantly reduces source turnaround times, reduces documentation errors, and improves PI oversight.

Experience and Global Reach

ProPharma has invested in hiring the best leaders within the Decentralized Clinical Trial (DCT) space to build out the most efficient operational strategy based on lessons learned from several years of past experience. As the decentralized approach grows in the clinical research space, it is becoming even more important for Sponsors to have a reliable partner that can assist in designing trials with decentralized approaches in mind. Our DCT leadership team has over 10 years of experience in the DCT space and can help your team design and implement the right DCT solutions for your trial. Whether you’re interested in hybrid or completely virtual clinical trials, our team of experts can help.

ProPharma has 27 offices worldwide spanning 6 continents, providing a truly global footprint to support your decentralized clinical trials. ProPharma has 20 years of experience supporting Sponsors from early development through commercialization, which allows for expert insight at any phase or function of your study and a streamlined approach from a single provider.

decentralized-clinical-trial-visit-procedures

Decentralized Clinical Trial Visit Procedures

Our decentralized visits include critical procedures for your clinical trial’s success. Let our team of experts review your protocol or draft synopsis and consult with your team on what visits or studies could benefit from a DCT model. Our procedural capabilities are as follows:

 

 

  • Vital Signs and Associated Variables
    • Temperature
    • Respirations
    • Blood Pressure
    • Pulse/Pulse Oximetry
    • Weight/Height/BMI
  • Lab Sample Collection and Processing
    • Blood/Plasma
    • Urine
    • Saliva/Sputum
    • Stool
    • Finger Sticks
  • IP Logistics
  • Targeted Clinical Assessments
  • IP Administration
    • Infusion
    • Injection
    • Oral
    • Topical
  • Telehealth Support
  • Patient-Reported Outcomes and Scales
  • Patient Training
    • IP Administration
    • Diary Completion
    • Device or Wearables
  • Other Safety Assessments
    • Changes in Health Status or Concomitant Medications
    • ECG Collection

Explore DCTs

Project-Based Solutions

Our team of project leaders and clinical subject matter practitioners can support you in your journey to successfully deliver projects, achieve critical outcomes, and realize or improve efficiencies. Whether you are looking for an expert to provide advisory services or several cross-disciplinary personnel our solutions-focused approach will add value to your organization.

Specialized Project-Based Services

Our team of qualified consultants apply proven and proprietary project management methodologies to help you successfully develop and launch products to market safely and quickly. By focusing on your desired outcomes, we take time to thoroughly plan the solution. We have done these projects before and understand the functional dependencies that can impact the plans and know what works.

In-Depth Expertise

Our team of clinical experts bring leadership to your projects to help you successfully complete your important, complex projects regardless of where your team is in the clinical development process. We help you get to decisions quickly and achieve outcomes.

Clinical Research Solutions Experts

Marcy Komocsar

Marcy Komocsar

Senior Vice President
Clinicial Research Solutions

marija buchholz headshot

Marija Buchholz

Senior Vice President
Global Clinical Operations

robert rachford headshot

Robert Rachford

Senior Director
Clinical Data Sciences

Tammy Dutkin

Tammy Dutkin

Vice President
Data Management & Programming

Mary Culliton

Mary Culliton

Senior Vice President
Global Medical Writing

ajay upadhyay headshot

Ajay Upadhyay

Vice President
Peri and Post Approval Services

shelby stillwagon headshot

Shelby Stillwagon

Senior Director
Decentralized Clinical Trials

Kevin Wysocki

Kevin Wysocki

President
Clinical Research Solutions

News & Insights

Life Science Consulting

December 6, 2022

Changes to the Animal Welfare Act That Affect Animal Research Facilities

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Ban on Titanium Dioxide (E171) on the EU Food Market: What Are the Consequences for Medicines?

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Company News Acquisitions ProPharma and Digital Consulting Logo

January 25, 2023

ProPharma Announces Acquisition of Digital Lab Consulting

PROPHARMA ANNOUNCES ACQUISITION OF UK-BASED DIGITAL LAB CONSULTING  TO EXPAND R&D CAPABILITIES AND ACCELERATE PRODUCT DEVELOPMENT RALEIGH, NC, January 25, 2023: ProPharma Group (ProPharma) the...

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January 9, 2023

ProPharma Group launches revolutionary new operating model

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January 9, 2023

Drug and Device Development Outsourcing 2.0 - Soaring Beyond the CRO

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May 3, 2022

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

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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...

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...

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June 10, 2022

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Free Webinar: Effective FDA Engagement

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Infographic Infographic

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...

News & Insights

Company News Acquisitions

January 25, 2023

ProPharma Announces Acquisition of Digital Lab Consulting

PROPHARMA ANNOUNCES ACQUISITION OF UK-BASED DIGITAL LAB CONSULTING  TO EXPAND R&D CAPABILITIES AND ACCELERATE PRODUCT DEVELOPMENT RALEIGH, NC, January 25, 2023: ProPharma Group (ProPharma) the...

Press Releases News

January 09, 2023

ProPharma Group launches revolutionary new operating model

$50m investment and rebrand unveiled at J.P. Morgan Healthcare Conference as part of new global growth strategy. RALEIGH, NC, January 9, 2023: ProPharma Group – the end-to-end, global provider of...

Company News

January 09, 2023

Drug and Device Development Outsourcing 2.0 - Soaring Beyond the CRO

ProPharma Group - the end-to-end, global provider of regulatory, clinical and compliance services for the pharmaceutical, biotechnology and medical device industries launched the Research Consulting...

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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...

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...

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...

Life Science Consulting

Dec 6, 2022 12:00:00 AM

Changes to the Animal Welfare Act That Affect Animal Research Facilities

Does your organization conduct or outsource testing to an Animal Research Facility?  If so, are you aware of the changes that have been implemented to the AWA (Animal Welfare Act) by the Animal and...

Regulatory Sciences

Nov 2, 2022 12:00:00 AM

Ban on Titanium Dioxide (E171) on the EU Food Market: What Are the Consequences for Medicines?

Use of Titanium Dioxide in the EU Food Market In 2021, the European Food Safety Authority (EFSA) investigated the safety of the white coloring agent titanium dioxide (TiO2) and concluded that the...

Life Science Consulting

Nov 1, 2022 12:00:00 AM

Be Careful What You Ask For (Prior to Consent)

According to FDA’s clinical trial regulations (21 CFR 50.20, 312.60 and 812.100), clinical investigators are responsible for protecting the rights, safety, and welfare of subjects during a clinical...

Infographic

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...

Webinar

September 27, 2022

Free Webinar: Effective FDA Engagement

FDA faces challenges (like new technology) and new review models (like real world evidence) that stretch agency standards and practices. At the same time, imperatives like product safety and efficacy...

Infographic

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

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Infographic

October 4, 2021

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EMA Approval Under Exceptional Circumstances

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May 19, 2022

Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective

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April 25, 2022

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March 25, 2022

Insider Talks - To Decentralize or Not to Decentralize … That is the Question

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March 21, 2022

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February 4, 2022

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October 14, 2021

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October 14, 2021

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January 25, 2022

20 Years of Improving Patient Health and Safety

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February 17, 2022

Supporting Decentralized Gene Therapy Visits

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December 7, 2021

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November 12, 2021

Expedited Programs Explained: How to Expedite Product Approval in the US and Europe

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October 14, 2021

Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors

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October 15, 2021

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October 14, 2021

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October 14, 2021

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October 13, 2021

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October 14, 2021

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October 4, 2021

ProPharma Group Overview Video

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.  

Flyers

August 8, 2022

QP MIA Survey - Progress Self-Assessment

Use this readiness questionnaire to assess the current state of your progress.

Whitepapers

March 21, 2022

Meeting the FDA's CAPA Expectations

Year after year, findings of insufficient corrective and preventative action (CAPA) procedures have topped the list of the most common observations found during FDA inspections within the medical...

Whitepapers

February 1, 2023

What You Need to Know About Regulatory Programs for Expedited Approval

Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Learn the similarities and differences between them to help determine the best option(s) for your product. The...

Flyers

February 3, 2022

EU IVDR Progress Self Assessment

The deadline for EU IVDR is May 26, 2022. Use this readiness questionnaire to assess the current state of your progress.

Flyers

October 14, 2021

EMA Services: Ensure Regulatory Success

Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)

Flyers

February 1, 2023

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Flyers

October 14, 2021

Cell and Gene Therapy Center of Excellence

Accelerating Your Product Through Development: Reducing Risk Ensuring Compliance, and Accelerating Access for Patients

Flyers

October 14, 2021

Data Integrity: The Quality of Your Product Depends on The Quality of Your Data

Regulatory Agencies Expect Controls to Be in Place

Flyers

October 14, 2021

FDA Consulting: Regulatory Strategy Expertise

Reduce Your Time to Market With an Effective FDA Regulatory Strategy

Flyers

October 4, 2021

ProPharma Group Services Overview

Improving Patient Health and Safety. At Every Step.

Flyers

October 4, 2021

Medical Device Development

Navigate Complex Global Requirements for Medical Device Approval

Flyers

October 4, 2021

EU Market Access: Accelerate Market Access to Europe with MIA License

Reduce Launch Timeline and Improve Business Efficiency

Flyers

February 1, 2023

Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

Save Time and Boost your Bottom Line

eBook

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...

Whitepapers

October 14, 2021

Good Science Presented Well Generates Approval

Without good data, any application has little chance of success. Working with a regulatory consultant that has an excellent understanding of the science and how to present it properly is the surest...

Whitepapers

October 14, 2021

How to Compile a Science-Backed New Drug Application (NDA) Submission

Developing a successful NDA is critical to the success of your product and company. Learn how to develop a science-focused submission like an expert with these six tips. You are getting ready to...

Whitepapers

October 14, 2021

A Guide for Efficacious Data Integrity During COVID-19

Learn how ProPharma Group implements data integrity measures to prevent reputation damage, unsafe products, and costs. With the current pandemic creating schedule delays, interrupting supply chains,...

eBook

October 14, 2021

Evolving EMEA MI Service Models

There are 116 countries in the EMEA region and around 24 languages spoken, how do you know what structure and model are best for each client and how do you go about making it happen? There are so...

Whitepapers

October 13, 2021

What You Need to Know About GxP Independent Compliance Audits

Simply having the appropriate standard operating procedures (SOPs) in place is not good enough; procedures must be followed to the letter. Prevent the consequences of quality systems being...

eBook

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...

eBook

October 4, 2021

Improving Product Quality During Technical Transfers

Is your product quality at risk during a tech transfer? Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time, resources, 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.