December 2, 2021
Here’s the plan for the video:
• What’s validation and why it is needed
• Validation flow
• What documents should a regulated company have after validation?
• What Flex Databases provides and covers
• What is left for a client to cover and how we can help
• Clients’ feedback about Flex Databases validation approach
Vendor oversight has always been part of clinical trial compliance, but ICH E6(R3) has significantly raised expectations for sponsors and technology vendors alike. The updated guideline makes one thing very clear: sponsors remain fully responsible for trial quality, patient safety, and data integrity — even when activities are outsourced to external vendors. This includes ensuring […]
We are looking for seasoned Senior Project Managers who is ready to take full ownership of high-impact projects. At our core, we value delivery over slides and results over rigid hierarchy. Our product is a SaaS eClinical platform designed for managing clinical trials and various business processes in the pharmaceutical industry. Our clients include biotech and pharmaceutical companies, as well […]
CROs work in a fast-moving and highly complex environment. They manage multiple studies at the same time, often for different sponsors, across different countries, sites, and timelines. Each study comes with its own processes, reporting needs, and regulatory expectations. As this complexity grows, it becomes harder to keep everything aligned using separate tools or spreadsheets […]
Risk management used to live in spreadsheets, scattered documents, and endless review meetings.Not anymore 👀 That’s exactly what our QA Director, Anna Petrovskaya , will be speaking about at the International QA Virtual Conference. Her session,▶️ “Risk Management Automation in the GCP R3 Era,”will explore why traditional, document-based risk management approaches are no longer enough, and […]
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