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LKF Clinical trial consultation

Consulting

The preparation of a clinical trial is always a critical point. We offer a broad spectrum of services covering all aspects of the laboratory part of clinical trials – from planning to final completion. Our team has substantial experience and expertise in a wide range of clinical indications, their diagnosis and therapy. We give you access to doctors, scientists, technicians and other experts for consulting.

LKF Therapeutic Areas

Therapeutic Areas

Over the last 20 years we executed 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.

LKF Project Management

Project Management

GBA Group 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
LKF Data Management

Data Management

GBA Group has developed a data management system meeting 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 customized to our client’s needs.

Our 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
LKF Logistics

Logistics

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

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How to reach us

We offer numerous locations and departments in Germany and Europe, so that you always have a reliable contact in your area.

Do you have questions about a certain topic? You need an individual offer? Contact us at the following e-mail address or use our contact form.

service@gba-pharma.com

Request for proposal:

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The experienced and highly committed GBA Group team offers a variety of different services in the following areas.

Specimen Management

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Safety Analysis

Bioanalytical Services

Reporting

Quality Assurance

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