Every aspect of sample management, from your sample being taken in the clinic through to analysis and beyond, is underwritten with quality process, validated systems and the utmost care.
Understanding the complexities of multi-site trials and having experienced first-hand the resultant challenges, our strategy is to have sample tracking and chain of custody a top priority at Colibri. Our Cloud based LIMS system ensures that individual samples can be tracked during the entire sample lifetime.
There is a risk of clinical error from unclear and overly complex laboratory manuals, therefore, all our laboratory manuals are kept CLEAR and SIMPLE, with only necessary information and pictorial representation for added clarity. Each of Colibri Scientific’s laboratory manual and kit type undergoes a ‘dummy’ clinical run to ensure clarity and completeness which minimises the risk of error in the clinic and optimises your sample quality.
- Sample tracking/chain of custody throughout sample lifetime
- Sample logistics
- Clinical kit production and distribution
- Laboratory manual writing
- Site training – investigator meeting or on site
- Project management
- Short and long term storage via our specialist partner
Sample Tracking / Chain of Custody
Our Sample Tracking Software, CloudLIMS, is fully validated, 21 CFR Part 11 compliant and GCP compliant.
CloudLIMS is an advanced Cloud based tracking and management solution for all your samples, whether they are in the clinic, in shipment, in the analytical laboratory or in storage.
Access to Colibri Scientific’s tracking system can be provided to the clinics and laboratories and, along with provided barcode readers, each sample’s chain of custody begins as soon as it is taken from the patient.
Colibri Scientific works with our partner specialist courier, Topspeed, to transport your clinical samples in the most efficient manner to clinics, testing laboratories or storage facilities. Thanks to Topspeed’s Advanced Notification Facility, we can identify the precise location of your samples in real time. This is in keeping with Colibri’s ethos of ensuring complete traceability of samples during transit and gives our clients peace of mind that valuable samples are in safe hands.
We ensure completion of all appropriate shipping documentation and permits and provide prelabelled shipping cool boxes which meet the appropriate regulations.
Air waybills are provided for international deliveries.
Clinical Kit Production and Laboratory Manuals
Patient and visit kits are produced at Colibri Scientific’s premises in Cheshire, England, by our on-site specialists and undergo a rigorous quality check process prior to being shipped to site.
Kits can be tailored to the patient level, if required, and our flexibility means that we can produce ‘reactive’ kits based on emerging data. All kits are produced by our on-site specialists and undergo a rigorous quality check process prior to being shipped to site.
Each site is provided with access to our on-line ordering tool to ensure a simple process for accurate kit reorder.
The risk of clinical error from unclear and overly complex laboratory manuals is high, therefore, all our laboratory manuals are kept CLEAR and SIMPLE, with only necessary information and pictorial representation for added clarity. Authors of our laboratory manuals have ‘bench’ scientist experience to enhance practicality and efficiency of content.
Each Colibri Scientific’s laboratory manual and kit type undergoes a ‘dummy’ clinical run to ensure clarity and completeness which minimises the risk of error in the clinic and optimises your sample quality.
Colibri Scientific’s project managers will provide training either at the Clinical Investigator Meeting or on an individual site basis, to meet with your requirements.
Additional training can be given for poorly performing sites.
Each trial is provided with a project manager who acts as the single point of contact.
Your project manager oversees end to end delivery of your laboratory operations. Their role includes:
- Ensuring timelines are adhered to, overseeing kit production
- Arranging kit and sample shipment
- Ensuring all required documentation and permits are in place for shipping
- Managing kit stock and expiry at each site and responds to queries
- Writing the laboratory manual