LKF – Laboratory services for clinical trials of phases I – IV
Independent medical laboratory for clinical trial laboratory services
LKF is an independent medical laboratory founded 1991 to support clinical trials of phases I – IV. From planning to completion, the broad spectrum of services covers all aspects of the laboratory part of clinical trials. LKF has considerable experience and expertise in a variety of clinical indications, their diagnosis and therapy.
With our global network of partner laboratories in Europe, North America, South America and China, we provide laboratory services for clinical trials around the world. Dedicated and experienced project managers are assigned to each study ensuring a long-term consistency within a project.
From the beginning, LKF was aware of the importance of a continuous and timely information of all responsible persons involved in a clinical trial - and we are convinced that communication is one of our strengths.
Our services for your clinical trial
Sophisticated specimen retention
LKF has created a sophisticated specimen retention and retrieval system, which provides comprehensive information on each sample. It ensures accurate tracking and enables instant access whenever additional or re-testing is necessary.
Besides the storage of specimens LKF offers aliquoting or pseudonymisation services for your specimens. Two dimensional datamatrix barcodes enable the tracking of each individual aliquot.
Thereby, national and international requirements on the privacy, the documentation and the traceability are met.
After completion of the analytical process, specimens are stored frozen as long as the client requests. Specimens are disposed only on the client’s written confirmation.
Specimen Storage
LKF offers long term storage of different specimen types under certain storage conditions, from liquid nitrogen (-196°C) and -80°C to + 37°C. Temperature monitoring, automated alerts and backup equipments safeguard your samples. Each specimen is tracked individually from accessioning to shipment or disposal. Our sophisticated storage system guarantees a 24h sample retrieval time from request until shipment.
LKF offers the retrieval, handling, storage and transportation of specimens to be analysed by a referral laboratory, e.g. for pharmacokinetic or molecular assays. LKF has established special procedures for the management of genetic samples including a reliable double coding step to ensure full compliance with data privacy rules.
Safety Analysis
LKF offers a comprehensive clinical laboratory testing programme. Whenever possible, the methods and procedures applied are those recommended by international scientific societies, e.g. IFCC, ECAT, or traceable to approved reference material.
Furthermore, LKF has expertise in the development, evaluation and reference interval establishment of new analytical methods.
Analyses are performed in a timely and accurate manner. Measurements of routine and safety parameters, including reporting of test results, are usually completed on the day of specimen receipt, six days a week.
LKF provides analytical services in the following sub-specialities:
- Clinical Chemistry
- Hematology
- Flow Cytometry
- Coagulation
- Endocrinology
- Immunology
- Serology
- Microbiology
- Molecular Biology
- PBMC Isolation
- Pathological Anatomy/Cytology
- PCR
- MSD
A wide range of bioanalytical methods
LKF provides a wide range of bioanalytical methodologies supporting all phases of the drug development process. Our highly qualified staff is experienced in the following bioanalytical areas.
Large Molecules
- Enzyme-Linked Immunosorbent Assays (ELISA)
- Radioimmunoassays (RIA)
- Immunradiometric Assays (IRMA)
- Chemiluminescence Immunoassays (CLIA)
- Electrochemiluminescence Assays (ECLIA)
- Flow Cytometry
Special Services
- Coagulation Assays
- Anti-Drug Antibodies (ADA)
- Customized Assays
Your direct contact
Christian Klauke
Director of Business Development
+49 4307 8276 – 0
email: bd@lkf-kiel.de
LKF has set up a stringent quality management system based on the international guidelines GCP and ISO 17025. This ensures an excellent quality performance and enables us to prove the quality required for clinical trials at any time. Analytical quality is regularly certified by participation in proficiency testing programs, e.g. NGSP for HbA1c (Level I Certificate ) or INSTAND e.V.
About LKF
Today, LKF has more than 150 employees and is a part of GBA Group Pharma.
Our company comprises 6 major departments:
- Study Management
- Lab Kit Supply
- Logistics
- Laboratory and Research
- Data Management
- Quality Assurance