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.
Your direct contact
Matt McCarthy
Managing Director
M.McCarthy@gba-pharma.com