Ensuring Conformance to CDISC Data Standards

Ensuring Conformance to CDISC Data Standards

Our friend and colleague Dawn Edgerton is back to provide us with more information on changing data standards and FDA submissions. Thank you Dawn for sharing your knowledge and expertise! Will your Study Data Meet FDA’s Technical Requirements for Submissions? Ensuring...
A Mini Introduction to CDISC Data Standards

A Mini Introduction to CDISC Data Standards

What’s happening with data standards and FDA submissions?  We know something is changing but are we all aware of what this means for us?  Our friend and colleague Dawn Edgerton does, and she’ll be explaining it in the next few blogs, starting now!  Thanks to Dawn for...
Travel Tips for CRAs

Travel Tips for CRAs

As a CRA you are probably well acquainted with incessant travel.  You may even think you know every tip or trick in the book to make traveling less painful, but do you still find yourself dreading even short flights to sites you are responsible for monitoring? If so,...
Tips For Writing a Great Proposal

Tips For Writing a Great Proposal

If you are a clinical research service provider you understand the significance of business development to the long term financial health of your company.  Because the majority of new business opportunities are received through a Request for Proposal (RFP), developing...
The Importance of Timely Monitoring Visit Reports

The Importance of Timely Monitoring Visit Reports

A Clinical Research Associate’s (CRA) job can be very demanding and involve intense multi-tasking.  There are many facets to the job outside of on-site monitoring including study start up activities and regulatory document maintenance, keeping up with Sponsor and site...