Clinical system and procedure development
Addomed follows its ICH and EU Directive compatible SOPs but is able to operate also under the client’s Standard Operating Procedures (SOPs). QA system ensures that required quality level of tasks and results is attained during performance of clinical trials and other activities of the company. The basis is given in Quality Manual. A general QA plan covers activities and procedures within quality management system, SOP management, training, project management, CAPA management, IT development and other activities.
Development and writing clinical research SOP
Review of SOP for compliance with Good Clinical Practice and regulations