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

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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