jeudi 28 mai 2020
jeudi 21 mai 2020
mercredi 20 mai 2020
mardi 19 mai 2020
EMA notice to sponsors on validation and qualification of computerised systems used in clinical trials
The integrity, reliability and robustness of data generated in clinical trials, e.g. data submitted to support marketing authorisation applications (MAAs), are essential to regulators. Most clinical trial data supporting MAAs are now collected through computerised data collection tools, e.g. electronic case report forms (eCRFs) and electronic patient reported outcomes (ePROs). In addition, a wide range of computerised media and systems are used in the conduct of a trial, such as safety databases, systems for electronic interactive response technology (eIRT), clinical trial management systems (CTMSs) etc., the use of which will increase in the future.
Given recent inspection findings and the implications they have had on the integrity, reliability, robustness and acceptability of data in the context of MAAs, the GCP Inspectors Working Group (IWG) in cooperation with the Committee for Medicinal Products for Human Use (CHMP) sees the need to emphasize requirements for sponsors/vendors providing computerised systems or services as well as for the qualification and validation of computerised systems used to manage clinical trial data.
Link to document - CLICK HERE
on mai 19, 2020
vendredi 15 mai 2020
mercredi 6 mai 2020
lundi 4 mai 2020
Computer-aided biology describes a growing ecosystem of tools that augment human capabilities in the laboratory. In this report we give two case study examples of how computer-aided biology has transformed industrial gene therapy bioprocessing. In this Special Report, the authors describe how Synthace’s Antha cloud-based software platform has enabled industrial collaborators Oxford Biomedica and the Cell and Gene Therapy Catapult to harness the power of Bioprocessing 4.0 by:
- incorporating new process analytical technologies (PAT), such as Raman Spectroscopy, into their unit operations
- automating the upload, collation, organization, structuring, processing, visualization, and analysis of large bioprocess datasets from various sources
- precluding the need for data wrangling and reducing the time from data generation to high-value bioprocess insight from weeks to minutes.
on mai 04, 2020