Clinical Trial Safety Lab Testing
Clinical safety testing provides critical, protocol-driven data to assess patient safety and monitor investigational product tolerability across study timelines. In our safety testing laboratories, thousands of safety samples are measured per week using our state-of-the-art analyzers in Europe and North America. Two parallel automated systems guarantee fast and reliable results, which are always reported to our customers and are accessible in the mlm online® system within hours.
Our Clinical Safety Testing Areas
MLM Medical Labs has extensive expertise in comprehensive therapeutic areas and relevant safety testing. Our primary goal is to assist our clients with harmonized data, keeping clinical trials as safe as possible when developing new medicines and improving patient outcomes.
Some of our popular safety lab testing areas include:
- Hematology to detect drug-induced blood disorders
- Coagulation for testing potential bleeding risks associated with investigational drugs
- Clinical chemistry to assess liver and kidney function
- Urinalysis parameters to detect kidney damage and urinary tract abnormalities
- Serology to analyze immune responses to drugs or infections
- Cytokines to understand inflammatory responses and immune modulation
- Cardiac markers to detect drug-induced cardiotoxicity
- Hormones to assess endocrine-related side effects
- Tumor markers to monitor cancer treatment and detect recurrence
- Metabolic markers to assess metabolic disorders and drug-related metabolic changes
Harmonized Global Safety Testing
Our safety labs in Germany and the US conduct safety analysis with identical analytical platforms (cobas® 6000 and cobas® u411 (Roche), XN-1000 (Sysmex)) according to applicable regional guidelines (CLIA, Regulation (EU) 2017/746 (IVDR) and Rili-BÄK). MLM Medical Labs is also accredited by leading clinical laboratory organizations such as the College of American Pathologists (CAP).
Advantages of choosing our clinical safety lab testing services include:
- Harmonized SOPs: Having harmonized standard operating procedures (SOPs) ensures consistent and reliable results, reducing errors and creating smooth data comparisons.
- Harmonized reference ranges: Harmonized reference ranges, such as what is considered “normal," offer an accurate comparison of results from different labs to quickly spot potential safety issues.
- Identical quality management systems: All our teams follow the same procedures for training staff, handling samples and checking results to stay compliant with the highest quality standards.
- Harmonized analytical reports: Our safety testing provides 100% comparability of data to address potential safety issues quickly and make educated decisions for improved patient outcomes.
Why Trust Us?
At MLM Medical Labs, we are committed to improving global health to help achieve medical advancements for patient care. You can trust us to handle your safety testing because of our:
- Extensive experience: Since 1993, MLM Medical Labs has delivered scientific expertise, operational reliability and protocol-driven accountability across thousands of global trials. Our team of expert scientists is agile and flexible to easily adapt to trial protocols.
- Certified safety testing: MLM Medical Labs is compliant with CAP/CLIA and IVDR safety testing requirements. This standard is globally recognized and allows us to maintain consistency for reliable results that contribute to safer patient care.
- Quick turnaround times: Safety testing contains pertinent information to continue a clinical trial. To reduce delays, MLM Medical Labs provides same-day reporting for safety labs in clinical trials.
- Comprehensive, compliant analytical services: We have a wide range of tests and analyses for clinical trial safety testing, covering everything you need for your study. MLM Medical Labs prioritizes effective communication and data availability to keep you in the loop throughout the entire process.
Connect With MLM Medical Labs Today
Expedite your new therapies for patients worldwide using quality clinical safety testing from MLM Medical Labs. Request a proposal or contact us for more information today.