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RegisterStart of referral: Micro Therapeutics Research Labs, India [GxP / QC / QA]
- ECG recordings showed inconsistencies (intentional misinterpretation)
- Generating source data retrospectively
- Documentation of incorrect information
- Overwriting and changing raw data without ensuring the readability of the initial entry
- Implausible changes without a sound justification
- IMP shipped before approval
...
O.k., the CRO worked at least in a slipshod way, but are they really that stupid, lazy or untrained or are there other reasons that can not be proven but which forced EMA to look for findings (or to interprete observations in such a way) as mentioned above, which -honestly- will more or less appear in each study if you only search sufficiently.
The issue with GVK layed in bioanalysis and the referral was due to ECG recordings and similars....
- Generating source data retrospectively
- Documentation of incorrect information
- Overwriting and changing raw data without ensuring the readability of the initial entry
- Implausible changes without a sound justification
- IMP shipped before approval
...
O.k., the CRO worked at least in a slipshod way, but are they really that stupid, lazy or untrained or are there other reasons that can not be proven but which forced EMA to look for findings (or to interprete observations in such a way) as mentioned above, which -honestly- will more or less appear in each study if you only search sufficiently.
The issue with GVK layed in bioanalysis and the referral was due to ECG recordings and similars....
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Start of referral: Micro Therapeutics Research Labs, India Dr_Dan 2016-12-20 09:33 [GxP / QC / QA]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Start of referral: Micro Therapeutics Research Labs, India Ohlbe 2016-12-20 10:04
- Start of referral: Micro Therapeutics Research Labs, India nobody 2016-12-20 10:15
- Start of referral: Micro Therapeutics Research Labs, IndiaDr_Dan 2016-12-20 11:05
- Start of referral: Micro Therapeutics Research Labs, India nobody 2016-12-20 11:19
- Start of referral: Micro Therapeutics Research Labs, IndiaDr_Dan 2016-12-20 11:05
- Start of referral: Micro Therapeutics Research Labs, India nobody 2016-12-20 10:15
- CHMP opinion Ohlbe 2017-03-24 14:30
- Oops! Helmut 2017-03-24 16:19
- Start of referral: Micro Therapeutics Research Labs, India Ohlbe 2016-12-20 10:04
Ing. Helmut Schütz