eTMF: Does the service user have a known physical condition that may inhibit cardiopulmonary function?

Risk-based management of clinical trials is the methodology that is currently recommended by regulators, however it has some direct consequences on monitoring and clinical trial oversight. Identify The transition plan identifies the team responsible for a successful transition, the tools, techniques, and methodologies required. Evaluate data needs to identify and Read more…

Security Engineering: How do you ensure the integrity of the data and the activities?

The data governance structure covers business rules and policies, the quality and integrity of data, security of data and compliance with rules and regulations, audits and controls, and much more, confidentiality, integrity, and availability are essential components of any effective information security program. Above all, facilities operations and maintenance encompasses Read more…