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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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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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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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Modern Tools for Decentralized or Virtual Clinical Trials
Modern Tools for Decentralized or Virtual Clinical Trials Advances in web-based and mobile technologies have led to...
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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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Clinical trials: considerations for designing and building an electronic data capture system (part 2)
Part 2: Considerations for designing an electronic data capture system for clinical trials with sponsors/CRO in mind....
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Clinical trials: considerations for designing and building an electronic data capture (EDC) system (part 1)
In clinical trials, electronic data capture (EDC) systems are widely used to collect data such as patient...
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Science of Patient Input (SPI): Part 3
Patient input into study design – participation considerations. The last, in a series about the science of...
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Science of Patient Input (SPI): Part 2
Last time we discussed how patients’ opinions can shape the design of a clinical study by altering...
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