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Solutions

Consulting

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.

Therapeutic Areas

Over the last 20 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.

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


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 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


Logistics

We have recognized, that your sample is the most valuable object under our responsibility. With more than 20 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.

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