Service facilities & Services

The services offered by Analytico Medinet and CRL.Medinet take in standard safety research, specialised analyses and pharmacokinetic determinations.

Process
In clinical trials, Analytico Medinet and CRL.Medinet take the following (preparatory) steps to guarantee the quality of the service:
· appointment of a Laboratory Study Coordinator and an International Account Manager for each trial
· defining an unambiguous laboratory protocol for each trial
· application of common procedures
· use of standardised tests and analysers with consistent reference intervals
· standardised reporting world-wide both as to form and content. 

Just as with all other analyses and services of Analytico Medinet and CRL.Medinet, the following aspects are of crucial importance for clinical trials: 
· advice in the selection of suitable laboratory tests and in the interpretation of results,
· supply of material for the taking of samples and their safe transport,
· extensive instructions for the processing, storage and transport of samples,
· laboratory tests in the areas of hematology, chemistry, urine analysis, immunology and drug tests,
· development of analysis methods, validation, technology transfer for medications, their building blocks and metabolites,
· carrying out analyses for active components and metabolites in samples for (pre) clinical trials to the benefit of pharmacokinetic and pharmacodynamic analysis,
· final reporting per document, by fax or via Internet,
· electronic management of laboratory data and the related reports.

Coordination
The Laboratory Study Coordinator supervises the whole course of the research from beginning to end and regularly discusses progress with the sponsor of the research and provides services in the area of study management. For each region that is involved in the research, a local study coordinator is appointed.
The study coordinators prepare the documentation that is necessary to execute the laboratory research and see to a good start for the study by having the sample kits and documentation ready and the training completed before patient recruitment begins.

During the course of the research, the coordinator supports both the sponsor and the researcher and discusses the needs of the customer and the solutions that CRL.Medinet can deliver. He or she takes care of the availability of the needed materials, organises reliable courier services, supervises laboratory and management reporting and processes demographic data.
On the basis of regular consultation with the customer the coordinator monitors progress on the research and ensures that the analyses and services continue to relate to needs.

Logistics
CRL.Medinet has developed well-functioning cooperational associations with the most important courier companies and with specialised medical courier services. CRL.Medinet provides the researchers with trial material in larger or smaller amounts, depending on the specifications of the customer.
CRL.Medinet arranges sample transport of all types: at room temperature, packed in dry ice or for infectious samples. All shipments are packed, of course, in accordance with the current IATA regulations. The network of courier services extends across:
· North, Central and South America
· Western and Eastern Europe
· Southern Africa
· Australia, New Zealand and South-East Asia.

Processing of samples
The samples that are delivered at CRL.Medinet laboratories are provided with unique order numbers and a bar code. They are registered manually and entered in the Laboratory Information Management System (LIMS).

CRL.Medinet makes use of a system of double data entry: the laboratory assistants carry out quality controls independent of each other. The samples are introduced to the test instruments in a fully automated way. The bar codes give the system information about the nature of the tests desired.
There is always a small percentage of samples that cannot be processed by the automated system. Such samples are processed manually by the laboratory assistants.

Data management
CRL.Medinet invests continually in data management. The systems for data management are continuously adapted to new developments in the industry, such as 21 CFR Part 11 and CDISC.

Reporting
The customer can select his or her own layout for the laboratory reporting. The design is adjusted to the needs of the customer. Furthermore, CRL.Medinet can deliver specific reports, with extra copies, on request. The results can be sent by e-mail or per fax to any desired number of receivers.

Via OASIS, the CRL.Medinet Internet application, the customer gets direct access to the relevant laboratory data after entering a personal access code.
Different study-management reports can be generated to follow the progress of the study.

Research management
CRL.Medinet offers sponsors world-wide service in the area of study management.
· unambiguous, standardised datasets,
· standardised test methods and reference ranges,
· a laboratory protocol in which all services are described,
· a special coordinator for laboratory research, who takes care of consistent and proactive communication with the sponsor.