Quality management

Addomed’s customized evaluation and support services for clinical quality assurance (CQA) compliance help ensure your organization maintains appropriate compliance with applicable regulations and good clinical practice (GCP). We offer quality assessments for every phase of development. Whether you need a GCP trainig, audit or assessment, we have a solution for you. Try our international audit services!

The responsibilities of the Quality Management Unit include:
Internal audit plan preparation and management
Quality assurance for clinical trials
Reference for ICH-GCP related issues
Training content preparation and delivery
Support in audit/inspection preparation at site
Ad hoc activities as per Sponsor’s requirements
FDA and/or EMA site preparation
General consultancy
Remote Auditing

We view remote audits not only as an interim solution during the COVID-19 pandemic but as a viable alternative for the future. To this end, we have developed innovative strategies for all types of remote audits (investigator site, vendor and internal process audits) and continue to refine these based on experiences made during these challenging times. These strategies include decision trees to assess the feasibility of remote conduct and methods for conducting a modified form of source data review/verification when the traditional methods are not possible and/or direct remote access is not allowed by regulatory authorities.