Laboratories involved in the analysis of clinical trial samples have recently received new regulatory guidance from EMA and FDA. The EMA reflection paper for laboratories that perform the analysis of clinical trial samples issued in 2012
MLM to present at the annual meeting of the DGGF in Magdeburg on Sept. 19, 2014 Read More »
Simultaneous assessment of a whole variety of biomarkers is relevant for several topics within clinical trials. Either there is the intention to investigate the pathophysiological processes or to test the efficacy of drug candidates based on biomarkers.
MLM invested in MSD Sector Imager Read More »
By end of March 2014 MLM has been re-certified by the NGSP as a level 1 laboratory for the assessment of HbA1c. This re-certification confirmes that MLM is one out of only two laboratories in Germany that is compliant with the highest quality standards in HbA1c analysis.
NGSP certificate has been successfully renewed Read More »
The draft guideline published by the FDA defines the criteria that have to be fulfilled by analytical methods used for the assessment of drug compounds and their metabolites and of biomarkers.
FDA issued draft guidance on Bioanalytical Method Validation Read More »
‘Choosing the right lab: Big is not always beautiful’ is the title of a paper written by Prof. Dr. Stephan Wnendt and Dr. Katja Neuer published in Journal for Clinical Studies. Thies paper summarizes some criteria for the choice of central
Choosing the right lab for clinical studies Read More »
MLM is holding the DIN EN ISO 15189:2007 accreditation as a medical laboratory since 2003 and was subjected to a re-accreditation inspection by the German accreditation authority, the so-called DAkkS
MLM has successfully been re-accredited according to DIN EN ISO 15189:2007 Read More »
MLM has been founded 20 years ago on September 9, 1993. For the first fifteen years we have supported clinical studies with the infrastructure of a clinical reference laboratory. Within the last five years
MLM celebrates 20 years anniversary Read More »
A mixed team from MLM and TNT successfully finished at the 2013 long distance triathlon in Roth, Germany on July 14. The 3.8 km swim leg was done by Stephan Wnendt, MLM, in 1 h 16 min, followed by 180 km on the bike done by Lars Huppertz
MLM congratulates CRS – Clinical Research Services Moenchengladbach GmbH, a clinical research organization for phase I/II studies, for the successful inspection by the Brasilian Health authority, ANVISA, conducted in November 2012.
ANVISA Approval of CRS Moenchengladbach and MLM Medical Labs Read More »
On June 24 and 25, 2013, Dr. Philipp Rösler, German Federal Minister of Economics and Technology, will visit Israel to foster the interaction between the Israelic and German biotech and pharma companies and research organizations.
