Quality Assurance

`all those planned and systematic actions that are established to ensure that the trial is performed and the data is generated, documented and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s)`

Quality Control

`the operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled` 

Audits

acromion provides on-site audits to verify that conditions, practices and processes are in accordance with the protocol, applicable SOP(s), Good Clinical Practice and the applicable regulatory requirements

acromion has established a Quality Management Group maintaining standard operating procedures (SOP´s) in respect to the worldwide harmonisation process in the performance of clinical trials considering continuous re-adjustments to legal requirements. 

The quality management group ensures that trials comply with national and international laws and standards at all times and satisfy uniformly high quality criteria, i.e. ICH-GCP conformity.

The quality management group also carries out regular workshops for acromion GmbH employees. These provide extensive information about various aspects of quality management, as well as current developments concerning laws, guidelines and regulations which are relevant for performing clinical trials.