Omega Biorepository

Introduction

Omega Biorepository is a biorepository infrastructure designed to ensure the secure, traceable, and study-specific storage of biological specimens collected within the scope of clinical trials and scientific research projects. The approach extends beyond storage alone and aims to manage the entire specimen life cycle end to end, from collection and processing to storage, recall, and transfer.

Laboratory, analytical, and operational services provided within the Omega ecosystem are delivered through Omega’s internal units or authorized partner infrastructures that comply with applicable standards, depending on the nature of the study, regulatory requirements, and methodological scope.

Accreditations, certifications, and official authorizations apply at the level of the unit or partner organization where the service is actually performed and are assessed on a study-specific basis for each service category.

Scope of Services

The scope of biorepository services is structured in a modular manner according to the clinical protocol, sampling plan, and analytical objectives, with all operational components critical for data integrity and auditability managed under a single coordinated model. This includes short- and long-term specimen storage depending on study phase and protocol requirements, as well as specimen inventory management with rapid localization and recall capabilities. Study-specific specimen processing services, such as aliquoting, relabeling, and de-identification, are performed as required, alongside the coordination of temperature-controlled logistics and transfer planning in line with protocol specifications. All activities are supported by a comprehensive documentation framework focused on audit trail and full traceability.

Storage Infrastructure and Temperature Zones

The Omega Biorepository infrastructure supports storage across multiple temperature zones aligned with the stability requirements of different specimen types. Storage strategies are defined based on protocol-specified stability data, analysis timelines, and potential reanalysis needs. This includes room temperature storage where applicable, short-term storage and temporary holding at +4°C, and protocol-dependent storage at -20°C. Long-term preservation is ensured through storage at -70°C or -80°C, while cryogenic storage under liquid nitrogen conditions is utilized when required by the study protocol.

Storage Infrastructure and Temperature Zones

The types of specimens eligible for storage are defined according to the study design and managed in alignment with protocol-defined acceptance criteria, with labeling, processing, and storage conditions standardized based on specimen type. These include serum and plasma, whole blood collected with anticoagulants such as EDTA (Ethylenediaminetetraacetic Acid), citrate, or heparin as specified in the protocol, as well as urine and Dried Blood Spot (DBS) samples. In addition, tissue specimens and related research materials, cell suspensions and PBMC (Peripheral Blood Mononuclear Cell) samples, and special matrices such as cerebrospinal fluid (CSF) and stool are handled when required, all in accordance with protocol-specific conditions.

The scientific value of biorepository outputs is directly dependent on the standardization of pre-analytical processes. During specimen receipt, the correct specimen-to-participant-to-timepoint matching is verified, and transport and acceptance conditions are assessed against protocol criteria.

  • Identity and label verification: matching of barcode, specimen ID, and visit timepoint.
  • Assessment of visit window compliance and delays (protocol-dependent).
  • Review of temperature logs and transport conditions (protocol-dependent).
  • Specimen suitability checks such as hemolysis, clotting, and insufficient volume (protocol-dependent).
  • Deviation recording, classification, and management of Corrective and Preventive Actions (CAPA) when required.

Specimen location, movement, and processing history are managed through a traceability-based inventory approach. The objective is to maintain full Chain-of-Custody throughout the specimen life cycle and to enable rapid and controlled recall processes.

  • Chain-of-Custody records covering receipt, processing, storage, and transfer steps.
  • Audit trail approach capturing who performed which action and when.
  • Rapid specimen localization with traceable placement at rack, box, and position level.
  • Recall scenarios enabling controlled access for reanalysis, interim analysis, or regulatory requests.

For selected clinical programs, the biorepository unit may also support study-specific preparation of specimens received from clinical sites. These activities are performed only when defined in the protocol and in accordance with approved procedures.

  • Aliquoting to minimize repeated freeze-thaw cycles and support multiple analytical needs.
  • Buffering or other pre-processing steps (protocol-dependent).
  • Relabeling and standardized barcoding (protocol-dependent).
  • De-identification to manage the linkage between personal data and biological material in compliance with the protocol (protocol-dependent).
  • Cryopreservation and preparation of cryogenic specimens (protocol-dependent).

The transport of biological specimens in clinical research represents a high-risk operational area due to temperature control and documentation requirements. Omega Biorepository plans and coordinates temperature-controlled transfers, cryogenic shipments, and relocation processes in line with study needs.

  • Temperature-controlled shipment and receipt processes using cryogenic transfer systems (protocol-dependent).
  • Packaging and labeling compliance for national and international transfer scenarios (protocol-dependent).
  • Delivery verification, review of temperature records, and acceptance decisions.
  • Planning for secure transport and relocation of specimen collections (protocol-dependent).

Business continuity is a critical requirement in biorepository operations to preserve specimen integrity. Accordingly, the infrastructure is designed to support uninterrupted operation and proactive risk mitigation.

  • Uninterrupted operation supported by backup power systems and business continuity plans.
  • Action plans and documentation systems for temperature excursion scenarios (protocol-dependent).
  • Secure facility management through access control and authorization.
  • Periodic maintenance, calibration, and compliance checks (protocol-dependent).

Biorepository processes are planned and executed in alignment with clinical research quality expectations. The documentation and record management approach is designed to ensure auditable, consistent, and traceable data.

  • Documentation practices aligned with ICH Good Clinical Practice (GCP).
  • ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available).
  • Version and change management ensuring controlled implementation of procedural revisions.
  • Audit-ready archiving and record management.

Biorepository services extend beyond storage alone. In multi-center and long-term programs, specimen life cycle management is a core component supporting data integrity, reanalysis capability, and operational efficiency.

  • Phase I–IV clinical trials: long-term storage, interim analyses, and reanalysis needs (protocol-dependent).
  • Translational sub-studies: management of archived specimens for biomarker discovery and validation (protocol-dependent).
  • Longitudinal sampling designs: consistent management of specimens collected from the same participant at multiple timepoints.
  • Consortium and multi-center projects: inter-site standardization, specimen visibility, and traceability.
  • Audit or regulatory requests: rapid localization, recall, and documentation delivery.

Omega Biorepository operates in an integrated manner with the HelixLab central laboratory and Omega Genetik infrastructure, supporting an end-to-end Core Lab operational model. This integration aims to clarify site-level specimen instructions, standardize data flows, and reduce operational uncertainty.

  • Integration with HelixLab: coordination of specimen processing, analytical, and reporting workflows.
  • Integration with Omega Genetik: specimen life cycle planning for studies requiring genomic and molecular analyses (protocol-dependent).
  • Protocol-compliant reporting and data transfer with defined formats and frequencies.
  • Audit-ready documentation ensuring traceability of specimen and data flows.