European Pharmaceutical Review
MARCH 12, 2024
This can be achieved by implementing electronic systems with built-in controls to maintain data integrity, audit trails and access controls. Good documentation practices. Following good documentation practices (GDP) throughout all stages of data generation, collection, analysis and reporting is vital.
pharmaphorum
OCTOBER 20, 2022
Apart from manual transfers of documents between colleagues, the data is relegated to one’s hard drive and can’t be queried at scale to evaluate performance or to inform future projects. This requires extensive planning; such wide-ranging analyses take years to orchestrate and include countless data sources.
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pharmaphorum
OCTOBER 4, 2022
It also enhances the patient experience with easy-to-understand clinical trial information, such as a video about the Biobank study, as well as informed consent documents for electronic signature,” he continued. This was delivered through a patient-centric video about the Biobank study presented to the patient on an iPad, Lee explained.
Pharmaceutical Technology
SEPTEMBER 7, 2022
The following is adapted from a presentation given by Dave Par é and Silvio Scozzari at the DIA 2022 conference. After AEs are recorded, they must be translated and put back out to doctors and scientists for processing. Adapting pharmacovigilance to deal with surging case reports.
ISPE
MAY 11, 2023
The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. to Industry 4.0 April 2015.
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