LKF - Your clinical trials partner

Preparation of a clinical trial is always critical. We offer a broad spectrum of services covering all aspects of the laboratory part of clinical trials - from planning to completion. Our team has considerable experience and expertise in a variety of clinical indications, their diagnosis and therapy. You have access to medical doctors, scientists, technicians and other experts for consultation.

Therapeutic areas

Over the last 20 years, we have conducted clinical trials in a broad spectrum of therapeutic areas. Our wide range of experience covers topics like women's health (contraceptives, acyesis, restoration of pleasure, etc.), men's health (aging, cancer, etc.), vaccine studies, dermatology studies and so on.

Trial preparation

LKF provides various customised services for setting up a trial:

  • a dedicated study manager assigned to each study
  • a trial-specific project and data management plan
  • a laboratory manual written in any major European language with detailed instructions for specimen processing and shipment
  • laminated collection charts
  • visit-specific kits for specimen collection
  • pre-printed trial-specific requisition forms, ID labels and (air) waybills
  • on-site training for investigators, CRAs and study nurses
  • presentations on investigator and/or monitor meetings
  • test data transfer.

Specimen management

LKF has created a sophisticated specimen retention and retrieval system, which provides various kinds of information on each sample. It ensures accurate tracking and enables instant access whenever additional or repeat testing is necessary. After completion of the analytical process, specimens are put into frozen storage as long as the client requests. Specimens are disposed only upon the client's written confirmation.

Specimen storage

LKF offers long-term storage of different specimen types under certain storage conditions including liquid nitrogen (-196°C) as well as ranges from -80°C to +37°C. Temperature monitoring, automated alerts and backup equipment safeguard your samples. Each specimen is tracked individually from accessing to shipment or disposal. Our sophisticated storage system guarantees a 24-hour sample retrieval time from the request until shipment.

Specimens for third parties

LKF offers the retrieval, handling, storage and transportation of specimens to be analysed by a referral laboratory; e.g. for pharmacokinetic or DNA/RNA assays. LKF has established special procedures for the management of DNA samples for genetic testing, including a reliable de-identification step to ensure full compliance with data privacy rules.

Data management

LKF has developed a data management system dedicated to the requirements of a medical laboratory dealing with clinical trials. Our reliable and flexible software complies with international standards (GCP/GLP, FDA 21 CFR Part 11) and takes our clients' needs into account.

LKF's data management system includes the following key features:

  • blinding of laboratory data
  • electronic archiving of source data; e.g. request forms, hard copies
  • import of external laboratory data
  • export of multiple output formats (ASCII, XML)
  • accommodation of different data structures (CDISC, OC, SAS or client-specific)
  • incremental or cumulative data transfer
  • support of eCRF and EDC systems using daily data transfer
  • data encryption
  • web-based data entry for third-party laboratories.

Resource Centre

  • how to perform a blood smear
  • how to ship samples
  • guidelines relating to clinical trials.

Central Laboratory

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 or ECAT) or are 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 the 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-specialties:

  • clinical chemistry
  • hematology
  • flow cytometry
  • coagulation
  • endocrinology
  • immunology
  • serology
  • microbiology
  • molecular biology
  • PBMC isolation
  • pathological anatomy/cytology.

Although laboratory methods are frequently modified or changed due to technical developments and/or methodological progress, consistency of methodology is provided for the entire period of a trial.

Bioanalytical services

LKF provides a wide range of bioanalytical methodologies supporting all phases of the drug development process. Our highly qualified staff are 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)
  • customised assays.

Reporting

The laboratory report contains the dates of specimen collection and delivery at LKF, demographic data and reference intervals. Results are flagged according to the specifications defined in the study protocol (e.g. reference range, alert values, exclusion/inclusion criteria). Patient results are transmitted as single and/or cumulative reports by fax, e-mail, regular mail or by courier service.

In addition, analytical results are available in a secure area of our homepage. A special report designed for our clients, the so-called OVERVIEW, is a spreadsheet file representing a compilation of the current status of a study (e.g. demographic data, missing information, site or country-related visit and enrolment status). OVERVIEW is available at any time via LKF's homepage or can be transferred automatically on a regular basis.

Global trials

LKF, together with a network of highly sophisticated central laboratories specialising in clinical trials, is your best choice for global trials. More than 20 years of experience in clinical trials, working together with logistics experts and partners, helps us to protect your valuable specimens on their way to us or to a third-party laboratory.

Bioanalytics

Our laboratory is certified according to ISO 17025 and all analytical procedures are in accordance with the relevant regulatory requirements (GCP/GLP/GMP). An independent quality assurance unit is involved in every bioanalytical project, from start to finish. Periodic inspections by sponsors and authorities lead to a continuous exploration of our regulatory compliance.

LKF offers bioanalytical assay development and validation according to the most recent FDA and EMA guidelines. Our experienced bioanalytical scientists ensure high-quality service based on the 'fit-for-purpose' approach adopted to the study needs:

  • exploratory analysis
  • partial validation
  • full validation.

All laboratory tasks are specified in study-specific bioanalytical protocols generated during the initiation phase of the project. Analytical data is maintained and managed using LKF's laboratory database, which is compliant with GLP and FDA 21 CFR, part 11. Laboratory results and statistical evaluations are documented in standardised bioanalytical reports.

Special analysis

LKF provides sponsor-adopted analysis. Nearly everything is possible. One example is a clinical trial with the need to quantify menstrual blood loss (MBL). Less than a handful of laboratories worldwide are able to quantify menstrual blood loss; LKF is the only one that can cover the whole package of supply, logistics and analysis. Even new sanitary products (tampons and pads) with superabsorbent polymer cores can be analysed in an advanced and specialised manner.

Another example is special coagulation assays. Due to our flexibility, we can offer nearly any test using any device.

Logistics

We recognise that your sample is the most valuable object in our responsibility. Due to more than 20 years of experience in the field of clinical trials, and because of our contacts with courier services, we can give you the assurance that everything that can be done will be done in order to guarantee your success.

About Us

Guiding principle

From the beginning, LKF was aware of the importance of continuous and timely information from all responsible persons involved in a clinical trial - and we are convinced that communication is one of our strengths.

LKF has set up a stringent quality management system based on the international guidelines GCP and ISO 17025. This ensures 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 programmes; e.g. NGSP for HbA1c (Level I Certificate ) or INSTAND e.V.

Company structure

Today, LKF has more than 80 employees and is owned by four partners with different medical backgrounds. Our company comprises six major departments: Study Management, Logistics, Data Management, Laboratory and Research, Finance and Administration, and Marketing & Business Development.

Products and Services

Contact Details

LKF
Email: [email protected]
URL: www.lkf-kiel.com/central

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