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
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ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
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ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies
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News & Insights
April 18, 2024
ProPharma Now Certified as Medidata Rave EDC Accredited Partner
Leading Research Consulting Organization (RCO) Receives Medidata Accreditation for the RAVE EDC Module, Enhancing Clinical Trial Efficiency and Data Integrity for sponsors. RALEIGH, April 18, 2024 –...
January 24, 2024
ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology
RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...
November 27, 2023
EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...
October 11, 2023
ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
Raleigh, NC, October 11, 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 15, 2023
ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies
ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...
March 25, 2024
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What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...
March 25, 2024
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What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...