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
September 10, 2025
FDA Launches Crackdown on Deceptive Drug Advertising
FDA’s new crackdown on deceptive drug advertising reshapes pharma marketing. Discover implications for sponsors, compliance strategies, and patient trust.
September 10, 2025
Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Co...
Discover two distinct paths for creating a global audit strategy in medical device companies, focusing on harmonization and compliance efficiency ahead of FDA's 2026 QMSR changes.
September 9, 2025
FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?
FDA will now release Complete Response Letters in real time. Learn what this transparency means for drug developers, investors, and the industry.
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.
September 9, 2025
Your Roadmap to European Drug Approval: The Complete Solution
Discover how ProPharma simplifies the complex journey to European drug approval by acting as a full-service Marketing Authorization Holder partner. From crafting regulatory strategies and...
September 3, 2025
Agility Meets Expertise: The ProPharma FSP Approach
Discover how ProPharma elevated the Functional Service Provider (FSP) Model by blending specialized expertise, agile resourcing, and innovative technology. By building dedicated teams, streamlining...
August 21, 2025
From Local Limits to Global Integration: Transforming Medical Information Servic...
Discover how ProPharma transformed medical information services in Japan by integrating global alignment with localized expertise. By harmonizing processes, cross-training teams, and tailoring...
October 16, 2025
AI in Medical Information: Who Holds the Responsibility?
In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what...
September 23, 2025
Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance
Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...
September 17, 2025
The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation
In today’s data-driven R&D environment, fragmented and incompatible data can stall innovation. This webinar, led by experts from ProPharma and CSL Behring, reveals how robust data standards,...
News & Insights
September 10, 2025
FDA Launches Crackdown on Deceptive Drug Advertising
FDA’s new crackdown on deceptive drug advertising reshapes pharma marketing. Discover implications for sponsors, compliance strategies, and patient trust.
September 10, 2025
Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Co...
Discover two distinct paths for creating a global audit strategy in medical device companies, focusing on harmonization and compliance efficiency ahead of FDA's 2026 QMSR changes.
September 9, 2025
FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?
FDA will now release Complete Response Letters in real time. Learn what this transparency means for drug developers, investors, and the industry.
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.
September 9, 2025
Your Roadmap to European Drug Approval: The Complete Solution
Discover how ProPharma simplifies the complex journey to European drug approval by acting as a full-service Marketing Authorization Holder partner. From crafting regulatory strategies and...
September 3, 2025
Agility Meets Expertise: The ProPharma FSP Approach
Discover how ProPharma elevated the Functional Service Provider (FSP) Model by blending specialized expertise, agile resourcing, and innovative technology. By building dedicated teams, streamlining...
August 21, 2025
From Local Limits to Global Integration: Transforming Medical Information Servic...
Discover how ProPharma transformed medical information services in Japan by integrating global alignment with localized expertise. By harmonizing processes, cross-training teams, and tailoring...
October 16, 2025
AI in Medical Information: Who Holds the Responsibility?
In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what...
September 23, 2025
Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance
Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...
September 17, 2025
The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation
In today’s data-driven R&D environment, fragmented and incompatible data can stall innovation. This webinar, led by experts from ProPharma and CSL Behring, reveals how robust data standards,...