Clinical Operations Services
Clinical operations are the key component behind successful clinical research, who are responsible for designing, conducting, and managing Phase I – IV trials.
As clinical trials have become more complex due to increased guidance and regulations, there's more pressure than ever on clinical operations teams. While some organizations may put more time and effort into this area, others are outsourcing their clinical trials to CROs with deep expertise in the particular field of research and that provide robust, end-to-end services to execute their trials successfully.
Our clinical operations team will work with you to optimize clinical trial design, implement patient-centric approaches, and guide you through the entire clinical development lifecycle. Learn how our experts can help in the multi-phase development of your clinical operations.
How Outsourcing Clinical Operations Can Help at Each Phase of Clinical Trials
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.
Phase I Services
We provide teams with clinical expertise and an extended suite of early-phase clinical development services specifically engineered to accelerate study progression. Together, our clinical operations team will successfully lead and execute your proof-of-concept study to Phase 2 trial.
Phase II and III Services
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 Ops team will get it done effectively and efficiently.
Phase IIIb and IV Services
The longevity of late-stage development studies within observational research and registry development requires dedicated resources. Our specialized clinical operations leaders have a wealth of experience in late-stage development and health outcomes. We will provide the support you need for the duration of the study.
Medical Devices and Diagnostics
Our team of experts provides support for the entire product lifecycle – from clinical study design and execution to on-market support to meet global regulations.
Our Key Clinical Operations-Related Service Offerings Include:
- Clinical monitoring services
- Electronic Trial Master File (eTMF) and clinical trial management system (CTMS) support
- Site selection and feasibility
- Site training and study conduct
- Clinical program and project management
Work With Our Experienced Clinical Operations Experts
Our clinical operations leaders have the expertise to help you design, conduct, and manage clinical trials for drugs and medical devices. Whether you need a partner to assist internal teams with the workload or outsource your entire clinical trial, our experts are here to provide support. Contact our team today to learn more about our clinical operations services.
News & Insights
July 31, 2025
Pros and Cons of Working with a CRO
Explore the pros and cons of working with a Contract Research Organization (CRO) and how ProPharma sets a new standard in clinical development success.
July 28, 2025
Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market
Learn about PADER, a crucial pharmacovigilance requirement for U.S. drug safety monitoring, and how it differs from PSUR in ensuring compliance and patient safety. Summarizing the main point of the...
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Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...
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ProPharma Recognized for AI Excellence at ECCCSA
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January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 24, 2024
ProPharma Honored in the 2024 Clinical Trials Excellence Awards
ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.
July 29, 2025
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For Medical Information (MI) teams navigating today’s evolving regulatory landscape, compliance isn’t just a requirement — it’s a strategic imperative. From managing off-label inquiries to...
July 29, 2025
Avoiding Common Pitfalls During FDA Inspections
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July 22, 2025
Inside FDA Review: Crafting a Quality ANDA Labeling Submission
Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...
July 10, 2025
MAH Essentials: Ensuring Compliance for European Market Entry
This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...
News & Insights
July 31, 2025
Pros and Cons of Working with a CRO
Explore the pros and cons of working with a Contract Research Organization (CRO) and how ProPharma sets a new standard in clinical development success.
July 28, 2025
Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market
Learn about PADER, a crucial pharmacovigilance requirement for U.S. drug safety monitoring, and how it differs from PSUR in ensuring compliance and patient safety. Summarizing the main point of the...
July 25, 2025
Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...
Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).
July 8, 2025
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 24, 2024
ProPharma Honored in the 2024 Clinical Trials Excellence Awards
ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.
July 29, 2025
Successfully Executing a Tech Transfer in a Week
Discover how ProPharma supported a $3B pharmaceutical tech transfer that was executed in just 3 days, relocating five complex product lines. The plan included FDA alignment, pre-approved protocols,...
July 29, 2025
Obesity – Accelerated Timelines
A mid-size biotech needed fast U.S. market entry for an obesity trial. ProPharma activated 20 sites in 30 days and enrolled 300+ patients—meeting goals despite an increased sample size. Strategic...
July 29, 2025
Key Compliance Challenges in U.S. Medical Information Services
For Medical Information (MI) teams navigating today’s evolving regulatory landscape, compliance isn’t just a requirement — it’s a strategic imperative. From managing off-label inquiries to...
July 29, 2025
Avoiding Common Pitfalls During FDA Inspections
Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...
July 22, 2025
Inside FDA Review: Crafting a Quality ANDA Labeling Submission
Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...
July 10, 2025
MAH Essentials: Ensuring Compliance for European Market Entry
This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...