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How To Implement Decentralized Clinical Trials

Implementing decentralized clinical trials (DCTs) involves leveraging digital health technologies and adapting trial processes to enable remote participation and reduce the need for physical site visits[1].  Here are some steps to consider when implementing decentralized clinical trials: Planning and Design: Strategically plan and design the trial to incorporate decentralized elements. Consider factors such as the […]
March 4, 2024

How to Deal with Unwilling Auditees

Dealing with unwilling auditees can be challenging, but here are some tips to handle the situation effectively: Establish clear communication: Clearly communicate the purpose and objectives of the audit to the auditee. Explain why their cooperation is important and how it benefits the organization. Build rapport: Try to build a positive relationship with the auditee. […]
March 4, 2024

Navigating Compliance: Understanding Computer System Validation (CSV) in GxP-Regulated Industries

In the dynamic landscape of industries regulated by Good Practice (GxP) standards, ensuring the integrity, reliability, and security of computerized systems is paramount. Computer System Validation (CSV) emerges as a crucial process, acting as a linchpin in maintaining compliance and data integrity.
February 29, 2024