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LKF – Central Laboratory for clinical trials of phases I – IV

Independent medical laboratory for clinical trial laboratory solutions

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 solutions for your clinical trial

Complete consulting through comprehensive expertise

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, technicans and other experts for consultation.

Broad spectrum of therapeutic areas

Over the last 30 years we conducted clinical trials in a broad spectrum of therapeutic areas. Our wide experience covers topics like diabetes, neurology, oncology, dermatology, cardiovascular diseases, womens health (contraceptive, acyesis, delight), mens health (aging men, erectyle disfunction) and vaccine studies.

Tailored project management

LKF provides various customized services for setting up a trial:

  • Dedicated Study Manager and Substitute Assigned to Each Study
  • Trial-Specific Project and Data Management Plan
  • Laboratory Manual written in any major European Language with Detailed Instructions for Specimen Collection, Processing and Shipment
  • Laminated Collection Charts
  • Visit-Specific and Color Coded 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
  • Electronic Data Transfer in Customized Formats

Medical 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, FDA 21 CFR Part 11) and is tailored to our client’s needs.

LKF’s Data Management System includes the following Key Features:

  • Blinding of Laboratory Data
  • Electronic Archiving of Source Data, e.g. Request Forms, Hardcopies
  • 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 by Daily Data Transfer
  • Data Encryption
  • Web Based Data Entry for Third Party Laboratories

Worldwide Logistics

We have recognized, that your sample is the most valuable object under our responsibility. With more than 30 years of clinical trials experience and with an intense contact to the courier services we assure that everything will be done to guarantee your success.

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
© 2023 GBA Group

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