Dear All,
has anybody experience regarding NGS data (clinical and pre-clinical) for submission to regulatory authorities such as FDA? I guess this type of data as supporting evidence for a mechanism, population stratification based on genotypes ... etc is rather new.
I'm aware of the MACQ and SEQC initiatives but how do people using NGS deal with it right now, e.g. what data do we need to store long term - SRF files or even the images (that could be a serious issue for our storage guys)?
kind regards,
Arne
has anybody experience regarding NGS data (clinical and pre-clinical) for submission to regulatory authorities such as FDA? I guess this type of data as supporting evidence for a mechanism, population stratification based on genotypes ... etc is rather new.
I'm aware of the MACQ and SEQC initiatives but how do people using NGS deal with it right now, e.g. what data do we need to store long term - SRF files or even the images (that could be a serious issue for our storage guys)?
kind regards,
Arne