Clinical LIMS Case Study

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

Introduction

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: Sample Flow at Multi-Sites

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.

Sheffield Biorepository, University of Sheffield
Illustration 1: Preparation of the Clinical kits at Colibri Scientific

Multifaceted Business Challenges

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.

Sheffield Biorepository, University of Sheffield
Illustration 2: Tony Parry, Senior Project Manager, working with CloudLIMS

Why Colibri Scientific Chose CloudLIMS

Sue Keeler, Managing Director at Colibri Scientific Ltd., started looking for an automated system that can track samples, maintain Chain of Custody (CoC) of samples, streamline sample operations at multiple sites, and can meet the regulatory requirements. Sue discovered CloudLIMS through an Internet search and requested a free trial. The CloudLIMS team upon contacting her, gathered the granular details of their sample operations, to understand their operational requirements. The team demonstrated CloudLIMS to them and explained how the LIMS can meet their requirements. Soon after the product demonstration, they decided to evaluate the product. The CloudLIMS team sent them a trial version configured per their requirements to facilitate the evaluation. The barcode templates were also configured for their desired samples types, which include archival tissue, blood, paired biopsy, plasma, etc. The CloudLIMS team organized a couple of online sessions to help them with barcode generation and sample label printing. They were happy with the product functionality, excellent customer support, and subsequently decided to manage their sample operations and clinical studies with CloudLIMS.

According to Sue, "We were looking for a package which would be suitable for tracking samples between different locations, generate barcodes, print labels and set up clinical studies. CloudLIMS enabled this and negated the requirement for large hardware costs – as a new business, this was very attractive. Also, being able to update numbers of licenses easily on a monthly basis is an advantage to an expanding business and enables us to tailor our contract with CloudLIMS to meet the requirements of our new clients. The support at CloudLIMS is excellent and I am very satisfied with their services."

How Colibri Scientific Leverages CloudLIMS

In order to sustain in the competitive clinical landscape, every organization needs to enhance its efficiency and minimize its expenses. A cloud-based LIMS is hosted on a secure cloud server and negates the requirements of IT infrastructure and IT personnel for LIMS deployment. CloudLIMS, a cloud-based LIMS, offered as Software as a Service (SaaS), leverages the benefits of Pay-as-you-go (PAYG) model to offer a cost-effective solution. Colibri Scientific decided to choose CloudLIMS because it not only helps them in efficaciously tracking a large number of samples in real-time across multi-sites but is also a cost-effective and scalable solution.

Currently, the product helps them in managing various studies, tracking and managing samples when they are in the clinic, in shipment, in the laboratory, or in storage, generating 2D-barcodes and sample labels, configuring electronic signatures for the desired laboratory activities, maintaining an automated audit trail to meet the clinical auditing requirements, and generating customized reports.

 


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