SCIderm Quality Management System

Since February 2008, SCIderm has been certified pursuant to the ISO 9001 Norm by the German Society for the Certification of Management Systems (DQS). Two expert reports will be issued to support the system of quality management before the next reassessment in 2011.

Using the Quality Management System, Contract Research Organization and research facility processes are monitored in the development and implementation of clinical studies of Phases II-IV and post-approval studies, as well as scientific-medical consultancy for pharmaceutical cosmetics companies.

When conducting clinical studies, the observance of ethical principles such as protection of subjects' rights in accordance with the Declaration of Helsinki as well as national and international guidelines is of great importance. Regulatory requirements for the execution of drug studies such as observance of Good Clinical Practice ("ICH-GCP"), the Drugs Act and GCP directive, and international guidelines 2001/83/EC, 2001/20/EC and 2005/28/EC have been implemented. With regard to studies with medical devices, the German Act on Medical Devices (especially MPG), relevant European guidelines (Dir 93/42/EC) and the international ISO 14155 Standard have been incorporated into the Quality Management System.

To ensure the security and correctness of data obtained via clinical study, SCIderm uses a validated data management system which complies with the requirements of the FDA "Code of Federal Regulations 21 part 11" (US law). Statistical evaluation is performed using the validated analysis software SAS.

Regular monitoring of the processes and assessment of the measures implemented serve to continuously improve our working results. Regular internal audits ensure that Contract Research Organization and research facility personnel always work in compliance with the appropriate current regulations and the processes defined in SOPs, and are regularly trained in accordance with work requirements.

We are assessed regularly through annual questionnaires completed by our test subjects and client representatives. The comments and suggestions obtained are taken into consideration in management decisions for further company development. Efficient order processing is of top priority and forms the foundation for successful cooperation with our business partners.

Our established Quality Management System ensures that SCIderm develops and conducts clinical studies of the highest quality for sponsors and clients, generates valid clinical data for study evaluation, and can provide professional scientific and medical consultancy for pharmaceutical cosmetic companies.