MLM Medical Labs (MLM) is a Central Laboratory dedicated exclusively to clinical trials. MLM offers full laboratory services, including a whole range of analytics: standard safety profiles, such as blood counts, coagulation, urinalysis and clinical chemistry, and analyses of biomarkers, drug compounds, metabolites and molecular diagnostic parameters. Internationally active for 25 years in over 40 countries MLM is located in Mönchengladbach, Germany. The MLM lab is on duty 365 days a year to ensure valid results with a quick turnaround time. Highly skilled with extensive clinical lab experience, our 60-person team supports over 140 clinical studies, phase I-IV at any given time.
MLM Medical Labs runs trials in a broad range of indications, including diabetes, cancer, infectious diseases, dermatology, and diseases affecting the cardiovascular, neurological and immunological system.
All members of the technical staff are certified research or medical assistants. 50% of the team has degrees in chemistry, biochemistry, biology or physiology and a third have completed PhDs in relevant fields.
MLM’s customers are renowned CROs and companies in the biotech and pharmaceutical industries in Europe, Asia and the U.S. To fully support this worldwide client base, we’ve developed an outstanding level of flexibility and dedicated ourselves to high-quality results delivered promptly.
In 2015 MLM forged a strategic alliance with Cenetron Central Laboratories, located in Austin Texas, USA in order to offer seamless laboratory testing for European and North American client sites.
› Development and validation of analytical methods
› Broad portfolio of validated biomarker assays
› World-standard analytical methods
› Clinical chemistry, hematology, coagulation, serology and urine analysis
› Complete analytical study reports
Management and Logistics
› Global study setup and project management
› In-house manufacturing of study-specific sampling kits: MLM Kit Building®
› More than 2700 sqm lab space
› Worldwide transport of clinical samples, sampling kits and supplies
› Long term sample storage at -30 °C, -80 °C and cry conservation: MLM Smart Storage System®
Superior IT infrastructure
› Online data-access and kit tracking: mlm online®
› MLM Smart Storage System® for safe and stable long term storage on a daily costs basis
› Electronic data transfer according to client’s DTA specifications
› Validated LIMS, digital SOP system and ERP
Standards for quality
CAP-, CLIA and DIN EN ISO 15189:2014-accredited, and GLP-certified, MLM conducts clinical trials in full compliance with EMA, FDA and GCLP guidelines. Sample handling and analytical procedures are entirely conducted by qualified personnel. All data is reported in MLM’s own laboratory information management system (LIMS), ensuring seamless tracking from sample receipt through analysis to final report generation.
The performance of the analytical methods is constantly monitored by internal and external quality controls. The laboratory participates regularly in proficiency tests with:
- RfB: Referenzinstitut für Bioanalytik
- INSTAND: Institut für Standardisierung und Dokumentation
- CAP: College of the American Pathologists
- NGSP: National Glycohemoglobin Standardization Program
MLM is certified by NGSP as level I laboratory.
Clinical logistics innovation
MLM Safeguard Box® efficiently protects samples against thermal stress and therefore contributes in a valuable way to the quality of safety data.
The main benefits are:
›Protective: Temperature stabilized during entire transport
›Convenient: All supplies delivered in one box, weight below 1kg
›Easy-to-use: Color-coded and pre-labelled tubes
›Traceable: Identification via barcode. Sample kit tracking via mlm online®