5 fast tips to make medical device clinical trials faster and cheaper

September 24, 2015

1. Keep your design simple.   More then 100 parameters per subject is too much.

2. Plan your time.  Start 6 months before first patient in. Plan to do a little bit every day.

3.  Use eSource.   Type the data directly into the EDC or into a tablet that inserts to the EDC

4. Ban SDV.   Your primary endpoint, IE and adverse events should not be on paper anyhow.

5.  Automate patient compliance measures. There are only 3:   1) Patient reporting compliance as measured by number of actual reports / number of expected reports.  2) Patient treatment compliance as measured by number of pills/treatment performed / number of treatment days  3) Number of compliance violations as measured by counting a clinical measure such as rescue medications.




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