Central Laboratory Services
Ensure data integrity, regulatory compliance and faster study timelines with MLM Medical Labs. As a centralized laboratory specializing in complex clinical and preclinical trials, we provide end-to-end laboratory support for biopharmaceutical and biotech companies worldwide. From study setup to data transfer, every step is tailored to your trial’s protocol and undergoes rigorous quality control testing to provide reliable results.
Our Central Lab Services
We offer comprehensive lab services to help our partners overcome the complexities of clinical trial testing. Our core service offerings include:
From developing user-friendly lab manuals to designing a custom database and data transfer plan, our setup services encompass all laboratory aspects of study preparation. Additionally, a dedicated project manager will facilitate communications between various departments throughout your study and be your single point of contact.
Using our proprietary MLM Kit Manager software, we’ll design custom sample kits tailored to your protocol. Each kit includes pre-labeled tubes with trackable barcodes and clear collection instructions, all protected within an MLM Safeguard Box® and shipped from our Memphis, North America, or Mönchengladbach, Germany, location.
We offer over 1500 sample testing parameters, including the FDA-cleared Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic test. Our scientists can develop, validate and perform custom assays based on your protocol, timeline and cost needs. We perform validation with a fit-for-purpose approach, which may include adherence to EMA and FDA guidelines for bioanalytical method validation.
We provide data transfers at your preferred interval, whether in real time, at regular intervals or at the trial’s end. All data transfers are encrypted and compliant with 21 CFR Part 11. We can also customize a data interface to meet your specific regulatory requirements, including SDTM and CDISC standards.
Rely on us for comprehensive sample management. Our chain of custody procedure includes audit trail tracking, scalable biostorage capabilities, reliable global logistics and 24-hour temperature monitoring, ensuring the traceability and integrity of your samples.
View lab reports and manage sample kit inventory from anywhere with mlm online® — our user-friendly, browser-based portal. Our premium version also includes real-time insight into our MLM Sample Storage System® so that you can monitor sample location and temperature control data.
Quality Services, Decision-Making Confidence
We simplify the drug development journey and empower our partners to make decisions confidently by offering the following:
- Highly flexible team: Our Ph.D.-level scientists, experienced project managers, scientific proposal writers, and in-house logistics professionals have the training and agility to respond to needs as they evolve. Whether you need to amend your protocol or adjust sample collection frequency, we can integrate changes seamlessly and rapidly, accelerating your study’s timeline.
- Essential accreditations and certifications: We have ISO, CAP and CLIA certifications and fully comply with EMA, FDA and GCLP guidelines. Be confident in your data’s reliability when submitting your trials for approval.
- Harmonized global support: Using standardized procedures, centralized data management and partnerships spanning five continents, we ensure consistent services and results, regardless of sample collection location.
- Advanced analytical capabilities: From preclinical in vivo GLP studies to neurodegeneration disease biomarker analysis, we provide analytical services using immunoassay platforms, flow cytometry and other instrumentation to meet your testing needs — whether you’re on the verge of innovation or navigating updates in Phase IV.
- Transparent and proactive communication: Your project manager will work closely with you throughout the drug development process, communicating with you regularly, openly and proactively to address any challenges or concerns. Additionally, they’ll ensure timely access to data so you can make informed decisions quickly.
Why Trust Us to Meet Your Clinical Trial Needs?
Our experience spans millions of samples from over 3,000 studies. We are committed to maintaining the integrity and traceability of your samples, offering analytical results you can rely on.
Our promise for quality also extends to our partner labs. We require each partner to undergo a stringent vendor selection and qualification process, including regular audits, questionnaires and performance discussions.
Since 1993, we have built strong partnerships around the world, providing a global reach without the taxing bureaucracy often connected to global laboratories. We offer expertise and comprehensive support to empower our clients to deliver quality medical advancements and improve patient outcomes.
Connect With Our Experts Today
The central lab services at MLM Medical Labs can provide standard and fully customizable sample testing. Contact our team today to discuss your study.