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A Quality Management System (QMS) is a structured framework of policies and processes that ensures the consistent delivery of high-quality services and products in compliance with industry…
Organizations require, in certain circumstances, additional help to navigate regulatory requirements and to choose the most efficient approaches to specific activities during the drug development journey…
GCP training is essential for maintaining high standards in clinical research, ensuring that trials are conducted ethically and in compliance with regulatory requirements…
Audits are systematic and independent examinations of trial-related activities and records, performed to determine whether the evaluated trial-related activities were conducted according to the protocol, GCP and the applicable regulatory requirements…
Managing a clinical trial can be complex and involves multiple functions, requiring effective organization, planning and documentation to ensure compliance, data integrity, and smooth study execution…
Clinical Site Management includes the selection and training of the right sites for the trial as well as overseeing site activities, protocol compliance, patient recruitment, and data quality, all while supporting and mentoring site staff…
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