Certain circumstances or types of device may require that you obtain clinical
data in order to support your submission. Obtaining clinical data can be
expensive, and it is inherently complicated. Do it right and the data is yours
to use. Do any part of it wrong and it may all be disqualified from use.
- We can educate you up front about the regulatory requirements to do it
right the first time.
- We can write or review your protocols. This will help you to right-size
the number of subjects and to create a trial you can afford.
- We can help you to create the tools necessary for the efficient
completion of the trial. These would likely include data sheet CRFs,
informed consents, protocols, and related SOP, and can further create the database tools
necessary for the analysis of the data.
- We can help to analyze your data to ensure that you are able to draw the
most meaningful conclusions from it, and then help in its presentation.
We've been through the wars with clients who have done clinical trials "the
hard way", and frankly what we've learned can be used to your benefit. Let's
avoid the common errors and get on with the science.
- Getting Started
- We discover what is being tested and help to develop meaningful
controls, sample sizes, numbers of sites, and exclusion criteria. We can
supply IRB and where needed FDA submissions for approval.
- During the Trial
- We have seasoned monitors that can help to assure that things stay on
track and compliant. We'll also support ongoing IRB and FDA reporting
- When It's Done
- We can help assure data integrity, develop and validate the database,
and then analyze the data to extract the