Preparation and Realization of Laboratory Analyses for clinical trials, immunogenicity services and consultancy
The Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics (ILM) has acquired a broad expertise in the successful organization and performance of local, national as well as international basic research studies and clinical trials over the last 10 years.
The ILM as a safety lab offers an entire spectrum of both clinical and molecular laboratory diagnostics and is accredited according to the guidelines 98/79/EG, DIN EN ISO/IEC 17025 (ZLG-P-578.04.08-01), 93/42/EWG, 90/385/EWG and DIN EN ISO 15189 (ZLG-P-578.04.08)
Located in the middle of Europe and supported by an excellent infrastructure, short routes of transport for specimen to the ILM Leipzig are guaranteed from various countries. In addition, as a 24/7 laboratory specimen can be dispatched 24 hours a day and also on Sundays and national holidays.
Furthermore, we offer long term storage of study samples, training of the study investigators and will assist our partners by providing consumables like study specific designed kits or by preparing laboratory manuals for the respective study sites. Moreover, state of the art media like FTP, data export or E-Mail are used to convey lab reports.
Besides, a specialized and integrated study section of the ILM with experienced staff offers medical, scientific and methodical consultancy for drug developing companies. The main practical focus of this "immunogenicity section" lies on the development and validation of assays for the sensitive quantification of biological drugs, measurement of PD-biomarkers, determination of anti-drug antibodies (ADA) and cell based assays for the detection of neutralizing anti-drug antibodies (NAbs).
All work is performed in accordance to the latest FDA and EMA guidelines and is carried out on the basis of GLP.
We are pleased to offer our services to you. Please contact us for further information, comments, questions and suggestions.
Phone 0049 (0)341 97 22455/22450
Contact person: Yoon Ju Bae