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On the Record: Compliance with 21 CFR Part 11 in Clinical Trials
What is 21 CFR Part 11? The United States Code of Federal Regulations (CFR) includes regulations for...
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An Introduction to Implementing CDISC Study Data Standards
Importance of Study Data Standards Exchanging data globally has become much simpler as information technologies develop. However,...
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Effective management of your clinical trial budget
Successfully executing a clinical trial is a large undertaking that requires strategic planning and cooperation. Even if...
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Mid-Sized CRO Benefits
If you have decided to seek a CRO for a forthcoming study need, there are many benefits...
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CRO selection: How to get it right the first time
CRO selection can sometimes be difficult to navigate. “My favorite meeting to have with a CRO is...
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Clinical Trial Start-Up Top 5 Challenges
An efficient clinical trial start-up is essential to the success of a multicenter clinical trial. Initiating a...
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Early Feasibility Studies: Top 6 Considerations
Early feasibility studies (EFS) can be an important tool in the development of a novel medical device...
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Patient Engagement in Clinical Trials: Patient, Industry, and Clinical Investigator Perspectives
The Medical Device Innovation Consortium (MDIC) Science for Patient Input initiative has been working to promote patient-centered...
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How does an Early Feasibility Study differ from a Pivotal Study?
An Early Feasibility Study (EFS) is performed early in the device development process to evaluate the device...
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Hybrid Clinical Trials in the Age of COVID-19 and Beyond
We were recently invited by the orthopedic market intelligence firm ORTHOWORLD® to describe our experiences with clinical...
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Using Patient Preference Information (PPI) for Patient-Centered Medical Device Development
There is much interest in engaging patients in the medical device development process, at all stages of...
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Electronic Clinical Outcome Assessment (eCOA)
Electronic Clinical Outcome Assessment (eCOA) is a method of capturing outcomes data electronically in clinical trials. eCOA...
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