Know what’s inside:

Solutions

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.

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.

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

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

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.