September 1, 2020
Automated Testing

Lack of Assessment of Automated Test Execution Tools

Automated test execution tools can be used to improve efficiency and effectiveness. Like other software, test automation software may be standard, configurable, or custom, and should be specified and verified appropriately based on an assessment of risk; however, auditors frequently note that GxP software developers do not assess these tools […]
May 19, 2020

Validation and Qualification of eClinical Systems (2) – Contracts/Agreements

After the selection of a vendor, appropriate contracts should be put in place prior to the commencement of work. Contracts should clearly detail the delegated tasks, duties and functions between the parties, and the required standards of service.
May 14, 2020

Clinical Quality Risk Management

All the guidance documents published by the Regulatory Authorities during the COVID-19 Pandemic, highlight the need for risk assessments to be conducted by the clinical trials sponsors and Clinical Research Organizations (CRO). However, conducting risk assessments and developing adequate Risk Management Plans are not easy tasks. This article pretends to […]
May 13, 2020

Validation and Qualification of eClinical Systems (1)

Based on recent inspection findings, the GCP Inspectors Working Group  (IWG) and the Committee for Medicinal Products For Human Use (CHMP) recognize 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 […]
March 20, 2020

Updated Guidance on Clinical Trials Management & COVID-19

This article pretends to follow-up a previous publication we did covering the initial guidance that was provided by some of the European National Competent Authorities (NCA) with regards to the COVID-19 outbreak. Since the situation keeps evolving, almost every day we have been notified by different media that another Competent […]
March 16, 2020

Clinical Trials Challenges in relation to COVID-19

The COVID-19 dissemination is highly impacting the lives of all of us, personally and professionally and we still do not know how this situation will progress and when we could go back to normality. Working on clinical research, we need to keep on working to safeguard first the safety and […]
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