Risk management for GxP Technology Implementation

Risk management for GxP Technology We rely on technology in most areas of our life. All of the tools we use to get through our day are now built, operated, and managed via technology. The understanding that we have reached with technology is that it will do what its supposed to do,¬†with minimal interference or […]

Review of eSource for Clinical Trials

Review of eSource for Clinical Trials Overview – source data Electronic data in support of new drug applications have been the standard for submittal to regulatory authorities – ever since computers were found to be reliable and their prevalence made them readily available. For much of that time, however, the source documents on which the […]

FDA authorizes EUA for Monoclonal Antibody Covid treatment

On 09Nov2020 the FDA issued an Emergency Use Authorization for investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), […]

Computer System Validation in the Life Sciences: The Basics

Introduction Computer system validation in the Life Sciences is a process to ensure data integrity, particularly patient-related data, that is accumulated and stored in a computer system. One aspect of data integrity is ensuring that data is collected accurately – that is, the value of a data point is transferred to the system in a […]

Decentralized Clinical Trials

In recent years, increasing attention has been paid to a method of clinical trial design that de-emphasized clinical site visits in lieu of relying on patients for generated and collecting more data themselves. Among the drivers for this change were to simplify trial design, allow patients to avoid some portion of site visits, involve patients […]