Colibri Scientific Manages Studies and Streamlines its Entire Sample Operations using CloudLIMS

Colibri Scientific, a UK based company, provides flexible clinical sample services to clinical investigators, biotechnology and pharmaceutical organizations running early phase clinical studies. Colibri Scientific understands the importance of quality samples in research, therefore, efficiently manages each and every aspect of sample operations during the entire sample life cycle. They provide a wide range of services such as sample tracking, clinical kit production, sample logistics, site training, project management, laboratory vendor management, in addition to sample storage via their specialist partner. Colibri Scientific serves as a conduit between the trial sponsor, clinic and testing laboratory not only for the duration of the study but until the samples are permanently disposed.

Colibri Scientific sets a protocol for clinical study and prepares a Clinical Sample Report (CSR) Form. They then generate and print sample labels and barcodes, manufacture the required clinical kits and ship them to a clinic. The clinic collects samples from patients in pre-labeled sample vials or containers and stores them per the protocol until they are shipped. Colibri Scientific prepares electronic manifests, detailing samples to be shipped and notifies the clinic and the receiving laboratory of the shipment and receipt dates. On the scheduled date, the specialist courier delivers IATA compliant packaging and dry ice, the clinic staff packs the samples according to Colibri Scientific Laboratory Manual, and the courier transports the samples to the testing or the storage laboratory. Following testing, Colibri Scientific obtains consent from the study sponsor to destroy the samples. They also ensure that the documentation for sample destruction, by the testing laboratory, is completed and filed in the study file. Throughout the sample life-cycle, the location and status of samples are tracked.

Colibri Scientific wanted a cost-effective clinical Laboratory Information Management System (LIMS) that can meet the following requirements:

1) Manage a large number of clinical studies on a day-to-day basis.
2) Track samples across multiple sites such as a clinic or a testing laboratory, the ability to mark samples as “received” when it is received by the clinic or the testing laboratory.
3) Generation of sample barcode labels with several important details of samples.
4) Maintaining a complete Chain of Custody (CoC) of samples, right from the time samples are collected from patients to their final disposal, ensuring complete sample traceability at all times.
5) Batch editing of multiple sample information such as current quantity, maximum freeze-thaw cycle count, etc.
6) Managing storage location of all samples.
7) Associating samples with their donors/patients and related studies.
8) Meet regulatory compliance such as FDA’s 21 CFR Part 11, Good Clinical Practice (GCP), and audit trail.