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A Brief History of the Development of Clinical Research Principals, Guidelines, and Regulations
Hippocratic Oath The Hippocratic Oath was likely written between the 5th and 3rd centuries BCE. Its purpose...
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5 Aspects of Device Clinical Study Close-Out
A clinical study process that is often underappreciated is close-out. Regardless if the study was completed or...
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Selecting the Right Electronic Data Capture (EDC)
What is EDC? EDC stands for electronic data capture. This usually refers to the processes of an...
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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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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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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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Science of Patient Input (SPI): Part 1
The first of three, in a series about the science of patient input. It is tempting to...
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Inclusion/Exclusion Criteria development
There is frequently confusion about what items should be listed as inclusion criteria and what should be...
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