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
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ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook
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ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards
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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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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...
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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...
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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 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...
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...
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DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
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Accelerate European Market Access with Compliant and Comprehensive MAA Submission
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An Inspection-Ready QMS Accelerates Product Introductions in Europe
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Early Phase Oncology Program in Patients with Solid Tumors
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EMA Approval Under Exceptional Circumstances
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Evaluate Readiness and Compliance for Supplying Drug Product to EU/UK/EEC
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Cell and Gene Therapy Center of Excellence
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ProPharma Group Services Overview
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Medical Affairs
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5 Key Challenges in the Development of Cell & Gene Therapy
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June 27, 2023
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July 31, 2023
Compliance Auditing: Diving into Common Critical Findings
Compliance Auditing: Diving into Common Critical Findings Discover the crucial role of compliance auditing in the healthcare industry with our in-depth whitepaper, now available for download. Our...