Impact of COVID-19 on HV trials [Study Per­for­mance]

posted by Ohlbe – France, 2020-04-20 10:11 (588 d 12:59 ago) – Posting: # 21337
Views: 1,611

Dear Silvia,

» Could the Clinical step of a BE study (screening, recruiting, administration of formulations and blood samples extractions) be carried out maintaining the HV at their own homes (always with a nurse at all times and a medical doctor visiting all the volunteers, etc etc)?

Besides what you already mention (certification of clinical centres), I see several hurdles and I don't think what you propose would be feasible/acceptable for ethics committees and authorities:
Sorry but I think all we can do is be patient...

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,778 posts in 4,555 threads, 1,547 registered users;
online 11 (0 registered, 11 guests [including 8 identified bots]).
Forum time: Monday 22:10 CET (Europe/Vienna)

Mediocrity knows nothing higher than itself,
but talent instantly recognizes genius.    Arthur Conan Doyle

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5