ABL - Sample Analysis, Logistics and Project Management for Clinical Trials

ABL BV is an independent central laboratory dedicated to (multi-centre) clinical trials for pharmaceutical and biotechnological companies. Located in the Netherlands, ABL was founded in 1969 and has developed into a Contract Research Organization (CRO) that supports clinical trials and pre-clinical drug development studies worldwide. Over the past decades, ABL has earned itself a solid reputation for high-quality service based on wide-ranging professional expertise and close attention to its customers' needs.

ABL provides two types of services: ABL-BAS, the bio analytical service, and ABL-CTS, the clinical trial service. ABL-BAS focuses on the analysis of samples derived from pre-clinical and clinical studies. ABL-CTS offers support services for multi-site clinical trials ranging from sample logistics and source verification to data- and project management.

BIOANALYTICAL SERVICES

ABL-BAS offers a diverse range of techniques and assays supporting toxicological, pharmacological, pharmacokinetic and bioequivalence studies as well as veterinary drug analysis and time-critical central lab safety analysis. Most of our assays have been developed and validated in-house. Besides quantitative analyses, ABL also performs qualitative and semi-quantitative metabolism studies. Our highly skilled personnel are capable of solving complex analytical problems and can provide you with valuable support in method development and research issues.

Analytical techniques:

• HPLC with UV, fluorescence, photodiode array and electrochemical detection
• LC-MS/MS (Sciex API 365, API 3000, API 4000 and API 4000-QTrap)
• GC with flame ionisation detection
• GC-MS (Hewlett Packard / Agilent)
• Immunoassays (radioactive- and non-radioactive labels; AutoDelfia)
• Radioactive methods (oxidizer, radio HPLC)
• Clinical chemistry assays
• Haematology
• Serology

ABL operates under OECD GLP guidelines and has been certified by the Dutch authorities since 1992.

CLINICAL TRIAL SERVICES

ABL-CTS offers a broad range of support services providing its clients with the extra flexibility needed for the proper conduct of their multi-centre clinical trials. A team of experienced staff assists in pre-study consultancy and offers professional assistance during investigator and/or CRA meetings and on-site training.

From study start-up, dedicated project managers and co-ordinators are assigned to each protocol. This project team will be involved in all pre-study related activities, such as the design and production of the visit kits and the preparation of all sample related study documents such as sample accountability forms and the central laboratory service manual.

During the study the team is available to address problems, process queries and will pro-actively perform sample tracking with the courier service to ensure minimal transit times of samples.

Services provided:

• Participation at (study) investigators meeting
• On-site training of staff
• Study specific visit kits: complete yet flexible in deployment; expiry date control; components labelled with a unique barcode
• On-site delivery of supplies required for shipping diagnostic specimens (ambient or frozen) in agreement with the latest regulations (IATA, ADR)
• Customized request forms for re-supply and shipment notice
• Laboratory instruction manuals including quick reference sheets to improve study site compliance with the protocol requirements
• Dry-ice delivery on-site when samples need to be shipped frozen and dry-ice facilities are lacking
• Pre-printed IATA-compliant shipment documents
• Courier performance monitoring to ensure timely delivery of sample shipments
• Equip sites with sample processing/ storing equipment such as (refrigerated) centrifuges and freezers
• (Long-term) storage of frozen samples
• Fully customized laboratory reports
• Customer defined electronic data transfer

As a result, ABL-CTS can provide you with flexible solutions to fit your needs. Our unique Sample Management And Reporting Tool system (SMART) allows us to incorporate study-specific alert ranges and delta changes in our laboratory reports. Special flagging of abnormal results or exclusion criteria allows easy interpretation of laboratory results by the investigator. Data clarification queries are automatically generated and communicated to investigators and sponsor by ABL-CTS staff. Samples can be relabelled and/or blinded and forwarded to a sponsor's lab or a third party laboratory.

DATA MANAGEMENT

Clean data-reporting is enhanced by double data entry and automated demographic data and protocol compliance checks. Finally, data-export can be delivered electronically to the sponsor using direct modem communication, the Internet, or any other electronic media. All ABL-CTS source documents can be archived for any given period.