BIOSTÓR

Innovative Sample Management

Biostór uses powerful cloud-based tools for efficient patient and sample information management to empower international scientific collaboration.

Biostór’s patient and sample information management system conforms to a wide range of different regulatory standards and is FDA 21 CFR Part 11 and GDPR compliant. Bio-specimens are safeguarded by encryption and pseudonymisation and available for future research.

Determine the real-time status of:

  • sample procurement in each clinical site,
  • samples in transport to and in storage at the central storage repository,
  • samples distributed to analytical laboratories for testing and
  • the various assurances required or the necessary corrective actions if enrolment targets fall behind.

The quality of the primary sample container strongly impacts the integrity of the bio-specimen. Selecting the appropriate sample container is critical to ensure that bio-specimens endure transport and long-term storage conditions and remain unchanged. If correctly chosen sample quality is optimised, intra-sample variability minimised and samples are unaltered from the time they are initially procured.

Your supplier can provide you with a certificate of compliance covering the key features to assure: sterility, DNase-free, RNase-free, endotoxin-free, materials of construction, etc. Other factors to consider are the type of container seal and its ability to withstand storage conditions i.e. Room Temperature, 2-8°C, -20°C, -80°C or -196°C. Storage at   -196°C requires caps with silicone gaskets to tightly seal and prevent the ingress of liquid nitrogen. Each container should have a unique laser-etched linear or 2-D barcode identifier to comply with the principle of data minimisation e.g. data pseudonymisation prescribed in the GDPR.


Clinical Trials

Biostór is assisting in two ground-breaking clinical studies involving cell therapy treatments: ADIPOA2 (http://adipoa2.eu/impact/) in osteoarthritis and VISICORT in corneal disease and are working to employ innovation and reduce costs in the delivery of these breakthrough therapies between clinical sites and cell expansion laboratories.

Biostór ensures product quality, patient safety, data integrity and traceability and certifies compliance with all applicable rules for the collection, storage and future use of biological samples.

In accordance with the GDPR, we employ state-of-the-art encryption safeguards to protect personal data and use 2-D barcodes to pseudonymise the samples to ensure use in future research studies.


Tissue Establishment

Biostór is authorised by the Irish competent authority (www.HPRA.ie) for the storage activities it undertakes and its procedures and activities are biennially inspected and verified. We are required to keep detailed records of our activities and all documents and records are checked for accuracy and compliance and to ensure traceability.

Biostór has a certified quality system (QMS) based on the principles of good practice (GXP) which includes:  Standard Operating Procedures (SOPs), Forms, Guidelines, Training Programmes & Records, etc. We have a designated Responsible Person and all storage equipment used, the working environment and the work processes we follow are qualified.

Imports and exports of tissues and cells into or out of the EU from/to third countries can only be undertaken by an authorised Tissue Establishment