Quality Management

The acromion GmbH Quality Management Department

Our main focus is the continuous advancement of our quality assurance activities and techniques. Diligent control and self-control ensure that all ethical and regulatory requirements defining the quality of a clinical trial are fully met at all times and in all our operations.
To guarantee compliance with international quality standards, best practices and ethical principles for instance ICHGCP (Good Clinical Practice) E6, EudraLex Volume 10, Code of Federal Regulation 21 (CFR 21), other ICH guidelines (Quality, Efficacy, Safety, Multidisciplinary) acromion has designed a well-structured Quality Management System. Our activities are regulated by internal SOPs which are an important part of the QM System. These SOPs are followed by all our employees as a matter of course: safeguarding compliance to regulatory requirements and guidelines.
Continuous training and regular participation at QA and other relevant conferences keep our QA personnel’s high competence up to date and top level.
Of course, our clients conduct audits on a regular basis. From the company’s beginnings in 2002 on until today we have successfully passed every single external audit and all inspections without any critical or major findings.

acromion GmbH Quality Management Department offers:

  • Trial-specific audits (e.g., on protocol, CRF, Trial Master File and on-site)
  • System audits
  • Vendor audits to verify conformity of conditions, practices and processes to all relevant regulatory requirements.

Your Contact

Sabine Kürpick
QA Manager-Auditor
acromion GmbH

Europaallee 27-29
50226 Frechen

Phone: +49 (0)2234-20 37 37-19
Fax: +49 (0)2234-20 37 37-9

Send us an email