clinical research solutions
A global team of trusted experts for multi-phase clinical development.
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.
Clinical Research Solutions
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 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.
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
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.
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
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 Decentralized Clinical Trials
Embedded 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
News & Insights
May 29, 2023
Key Challenges of Specialty Pharma Drug Development Project Management
Specialty pharma companies are focused on developing drugs for niche markets, such as rare diseases, cancer, and other complex conditions. These drugs often require significant investment in research...
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Meet the Expert: Collin Freeman
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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...
News & Insights
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...
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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...
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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,...
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.