MEDISCIS staff members are continuously trained and quizzed on up-to-date industry practice standards and new safety methods to ensure the highest standards in trial management. However, Quality Control is not only an occupational requirement. Every MEDISCIS employee has learned to strive for continuous improvement in his/her day-to-day work.

QUALITY ASSURANCE

The internal QA department continuously ensures adherence to ICH-GCP guidelines and other regulations via regular internal QA audits and feedback meetings with Management. More specifically, all clinical and analytical study steps are verified in accordance with internal QA procedures.
Furthermore, regular audits are performed by national and international Competent Authorities. From the French Competent Authorities (AFSSAPS), we have been granted GLP compliance with the highest possible rating (Grade A).
Moreover, several thorough customer-requested QA-inspections revealed no major shortcomings in our trial management.

OUR STANDARDS

• Up-to-date SOPs
• ICH-GCP compliance
• FDA guidelines - 21CFR subpart11

QUALITY CONTROL

Quality Control, as outlined in detail in our SOPs, is performed on the study source documentation and Case Report Forms by our dedicated staff.