OCELLOS Core
OCELLOS Core is an initial step into digital Chain of Identity (COI) and Chain of Custody (COC) from your very first patient.
A fast, simple and cost-effective route into electronic COI and COC that can be validated within your quality systems. A more secure and compliant alternative to paper or spreadsheet based systems, OCELLOS Core allows critical stakeholders to view a centralized source of information.
OCELLOS Core is built on the same platform as the rest of the OCELLOS range so you can upgrade to the next solution as your therapy progresses with no need to re-deploy or re-train.
Why Choose OCELLOS Core?
For personalized medicines, COI and COC are amongst the first supply chain challenges faced in first-in-human trials. Traditional paper-based or spreadsheet COI solutions require time, resource, and cost to maintain accuracy; and ultimately, cannot be validated within your quality system.
Industry partners approached TrakCel to create a digital solution that can:
- Deploy quickly and cost-effectively
- Manage COI & COC
- Can be validated
Chain of Identity
OCELLOS Core manages the Chain of Identity for each therapy journey. The patient is enrolled using your own Patient-ID, and OCELLOS Core allocates a unique COI reference for that patient sample that will trace it through to patient administration.
Manufacturing, healthcare and therapy developer users can see the progress of the therapy all the way through to drug administration as the information is entered.
Chain of Custody
At each step of the process, changes in the custody of samples, cells or drug products can be tracked and recorded, and supporting documentation can be added to support the audit trail or facilitate other users.
When a file is uploaded to the patient record, it automatically undergoes a security scan to ensure that it is safe for other users to download.
This offers a central and accessible place to collate all of the documents that support a patient’s therapy, and a safe way of sharing files with partners.
A Glance at OCELLOS Core
COI Management
Enrol patients to create unique, compliant COI references and generate searchable and reportable records in real-time.
Track COC
Track chain of custody and upload security scanned supporting documents to the patient record.
Quality Validation
OCELLOS Core can be validated within your quality system and is supplied with documentation to support this process.