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 […]
Read MoreDealing 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. […]
Read MoreIn 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.
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