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RegisterMultiple methods within a single trial [Regulatives / Guidelines]
Dear Osama,
Well, I've seen a few too, and all used a single, central bioanalytical lab...
It is true that it requires some logistics: local processing and storage of the samples, delivery of dry ice, pick-up of the samples by specialised transporters etc. All this does have a cost. On the other hand, you save on the development and validation of a bioanalytical method at each local laboratory. Plus the audit of each lab and QC of what they do. And an increased variability means a loss of power, thus additional patients needed.
CROs involved in this type of studies usually have a network of clinical sites with which they are used to working. They take care of all the logistics. If not: find another... It's worth it.
❝ I have already dealt with such study conducted for an anti-cancer drug in different CRO's in different cities.
Well, I've seen a few too, and all used a single, central bioanalytical lab...
It is true that it requires some logistics: local processing and storage of the samples, delivery of dry ice, pick-up of the samples by specialised transporters etc. All this does have a cost. On the other hand, you save on the development and validation of a bioanalytical method at each local laboratory. Plus the audit of each lab and QC of what they do. And an increased variability means a loss of power, thus additional patients needed.
CROs involved in this type of studies usually have a network of clinical sites with which they are used to working. They take care of all the logistics. If not: find another... It's worth it.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Draft ICH M10 published Ohlbe 2019-03-03 23:18
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Consultation period? Helmut 2019-03-04 01:08
- EU/EEA Ohlbe 2019-03-14 23:16
- ICH M10 draft wienui 2019-03-13 18:06
- Multiple methods within a single trial Ohlbe 2019-03-13 18:21
- Multiple methods within a single trial wienui 2019-03-13 18:44
- Multiple methods within a single trial Ohlbe 2019-03-13 19:10
- Multiple methods within a single trial wienui 2019-03-13 19:35
- Multiple methods within a single trialOhlbe 2019-03-13 23:01
- Multiple methods within a single trial wienui 2019-03-13 19:35
- Multiple methods within a single trial Ohlbe 2019-03-13 19:10
- Multiple methods within a single trial wienui 2019-03-13 18:44
- one study, one method Helmut 2019-03-13 18:23
- Multiple methods within a single trial Ohlbe 2019-03-13 18:21
- Consultation period? Helmut 2019-03-04 01:08
Ing. Helmut Schütz