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Phases and Stages of Clinical Trials
Clinical research for pharmaceuticals and devices follows the same general path. The first trial is a small...
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The Value of a Clinical Events Committee (CEC)
What is a CEC? In clinical trials that include a high-risk patient demographic, a clinical events committee...
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The Power of Post-Market Clinical Data
For medical devices, ensuring safety and efficacy doesn’t stop once a product hits the market. Post-market clinical...
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Clinical Site Selection: Navigating the Complexities of Clinical Trial Success
Selection of an investigational site for a clinical trial is critical to success. Throughout a clinical trial,...
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Clinical trial monitoring
Monitoring Clinical trial monitoring is a constantly evolving field, now encompassing various approaches that work together to...
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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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