Quality in the Clinical Lifecycle – A Compliance Kit

Often clinical trial management and quality management are viewed as separate activities with different teams taking responsibility for each. However, regulatory bodies are increasingly demanding an integrated approach towards quality across the clinical trial lifecycle – right from the time of design to closeout and after.

Quality management is not something that can happen overnight or in a silo. In fact, to infuse quality into the clinical workflow, there is a need to bring in a culture of “quality-first” to every stakeholder involved.

The complexity of clinical trials has increased due to global supply chains and stringent regulatory requirements. In such a scenario, manual processes can be very ineffective and may not help achieve the ultimate goal of continuous improvement.

Automating and integrating clinical trial management with quality management right from the word go can help CROs and sponsors have better control and understanding of processes. The visibility and access to data can help improve processes, minimize errors, increase safety, and make the organization compliant.

In this eBook, we explore the following topics:

• Integrating Quality into the Clinical Workflow
• Common Quality Problems (& Solutions) in the Clinical Lifecycle
• 11 Ways to avoid FDA Warning Letters
• 18 Checklists & Templates to Digitize Clinical Compliance for Medical Device Regulations (MDR)
• And more