At ProPharma, we offer a unique approach to the traditional Clinical Research Organization (CRO) Full-Service Provider (FSP) model. As the world’s largest Research Consulting Organization (RCO), we provide tailored and customized FSP solutions designed to fit your precise needs. Our offerings are both cost-effective and quality-focused, ensuring that you receive the maximum value for your investment.
ProPharma offers a range of FSP models that can accommodate various requirements, providing specific therapeutic area expertise, operational expertise, and integrated processes and systems. Our primary goal is to identify the most appropriate outsourcing approach for your project, ensuring a perfect fit for your needs. Our expertise spans across clinical operations, clinical data sciences, biostatistics, safety, nonclinical, and medical writing, enabling us to assist our clients in developing comprehensive FSP solutions.
FSP Resourcing Solutions
The global shortage of resources is a crisis that impacts the entire pharmaceutical industry. Finding experienced talent has become increasingly challenging and expensive. Utilizing smart recruitment strategies that leverage both our clinical recruitment team and the resources of Planet Pharma, our access to talent is unparalleled. Whether you need to outsource an entire function or establish a small, focused team for a specific area, we can find you the best-in-class expertise to develop an FSP where others fail.
Portfolio Management with FSP
Accurately forecasting resourcing needs is always a challenge within the clinical trial domain. With over 20 years of experience in developing FSP solutions, ProPharma understands the need to make nimble adjustments as queries and responses from regulatory bodies frequently impact clinical timelines. As more than just a staff augmentation provider, ProPharma can help you in efficiently managing your portfolio of work and partner with your leadership to adjust your resource strategies as needed.
Partner with us!
Exceptional Quality
By monitoring key metrics, checking for variations, evaluating enforcement trends, and investing in industry-leading expertise, we become your partner in achieving measurable results. When you work with us, you gain access to 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.
Therapeutic Expertise
Our global team consists of Subject Matter Experts (SMEs) with diverse 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 strategies that fit our clients’ unique needs. Having a top-tier team of professionals allows our FSP infrastructure to move resources internally across clinical programs.
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 efficiency.
100% Dedicated Teams
We not only provide FSP solutions but we also tailor them to your needs by engaging experts who are experienced across all phases of clinical development. At ProPharma, we know that a successful compound starts with assembling 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.
Hybrid FSP Solutions
In line with our flexible, customized RCO approach to providing solutions to the pharmaceutical industry, our approach to FSP is to always provide a thoughtful, tailored solution to your unique need. We carefully analyze the type and volume of work and provide you with the most logical, cost-effective model, whether it is FTE-based, unit-based, time & materials, or a hybrid approach.
In addition, when outsourcing a cohesive book of studies for full-service support, ProPharma can provide a hybrid FSP/FSO (Full Service Outsourcing) approach that provides the best of both worlds: end-to-end clinical study support that utilizes dedicated resources to ensure consistency and transferability of knowledge from one study to the next. With this model, you can have confidence that each study is approached with the same level of expertise and gain efficiencies through increased compound knowledge.
Single or Multi-Functional Solutions
We offer FSP solutions in a variety of functional areas including:
- Clinical Operations
- Medical Writing
- Regulatory Writing
- Publication Writing
- Document Quality Review
- Biostatistics & Statistical Programming
- Data Management
- Pharmacovigilance Services
Robust Quality Oversight
ProPharma's FSP solutions include complete ownership of the quality of work in support of clinical trials with multiple touchpoints for issue escalation including:
- Executive Leadership Oversight
- Governance Structure
- Joint Operating Committees (JOC) for multi-functional engagements
- Functional Governance Committees
- Operational Leadership
- Customized quality metrics with convenient read-outs provided in the form of dashboards or PowerPoint presentations
- Support from the ProPharma Quality Team
Flexible Billing Models
We can tailor an FSP solution to fix the needs of any scope of work, including:
- FTE fixed monthly rates
- Time & Material
- Unit-based Pricing
- Hybrid models of any of the above
What a ProPharma FSP Means to You
At ProPharma, FSPs are true functional partnerships – we become an extension of your team, fully dedicated to the delivery of your clinical portfolio. With our FSP solutions, you will benefit from:
- Reduced administrative burden: We handle the day-to-day management of staff and operations so you are free to focus on critical concerns.
- Consistency of support: Our dedicated FSP teams gain compound knowledge that carries over across studies as well as a deep understanding of client processes and culture.
- Continual monitoring of robust KPIs and metrics: We value quality of delivery above all else, and track and record our performance against established metrics.
- Assistance with portfolio and resource management: We offer support to balance against unforeseen changes in clinical timelines and resourcing needs.
- Cost savings: FSP models typically provide substantial cost savings to clients compared to more traditional outsourcing models.
News & Insights

September 27, 2023
The Impact of a US Government Shutdown on the Food and Drug Administration
U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...

September 25, 2023
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...

September 27, 2023
ProPharma Appoints Alena Hammond as Global Head of Clinical Operations
Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

September 13, 2023
ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI
Raleigh, NC, September 13, 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 30, 2023
ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho
RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

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 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

September 27, 2023
ProPharma Appoints Alena Hammond as Global Head of Clinical Operations
Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

September 13, 2023
ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI
Raleigh, NC, September 13, 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 30, 2023
ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho
RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

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...

Sep 27, 2023 11:57:42 AM
The Impact of a US Government Shutdown on the Food and Drug Administration
U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...

Sep 25, 2023 4:59:00 PM
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...

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...

September 27, 2023
How a Two-Part NDA Regulatory Strategy Resulted in Submission Success
Developing a New Drug Application (NDA) for submission to the FDA is an extremely complex process and one that can present challenges to even the most seasoned professionals. From ensuring you have...

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...

September 27, 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...

September 27, 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...

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...