What is 21 CFR Part 11? The United States Code of Federal Regulations (CFR) includes regulations for...
Importance of Study Data Standards Exchanging data globally has become much simpler as information technologies develop. However,...
Successfully executing a clinical trial is a large undertaking that requires strategic planning and cooperation. Even if...
If you have decided to seek a CRO for a forthcoming study need, there are many benefits...
CRO selection can sometimes be difficult to navigate. “My favorite meeting to have with a CRO is...
An efficient clinical trial start-up is essential to the success of a multicenter clinical trial. Initiating a...
Early feasibility studies (EFS) can be an important tool in the development of a novel medical device...
The Medical Device Innovation Consortium (MDIC) Science for Patient Input initiative has been working to promote patient-centered...
An Early Feasibility Study (EFS) is performed early in the device development process to evaluate the device...
We were recently invited by the orthopedic market intelligence firm ORTHOWORLD® to describe our experiences with clinical...
There is much interest in engaging patients in the medical device development process, at all stages of...
Electronic Clinical Outcome Assessment (eCOA) is a method of capturing outcomes data electronically in clinical trials. eCOA...
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