Cell and Gene Therapy Consulting Services

TrakCel Consulting are proud to offer the following cell and gene therapy consulting services; COI and methodology, data protection compliance, label design and compliance, supply chain risk assessment, and SaaS within pharma.

View the full list of cell and gene therapy consulting services below;

COI Strategy and Methodology

TrakCel Consulting Services have had a vast experience of COI strategies for all types of advanced therapies and classifications of starting material. Patient safety is at the heart of COI management, but methods used to guarantee COI fidelity should match the stage at which the advanced therapy is being supplied. Potentially utilising different strategies for early phase vs late phase vs commercial supply.

Our cell and gene therapy consultants will evaluate different COI standards and apply them to different drug products, intermediates and starting materials (e.g., apheresis, bone marrow, tumour biopsy). Providing candid advice and strategies to address the regulatory frameworks of COI management and the practicalities of COI management.  

Data Protection and Compliance

Within cell and gene therapy consulting, we are often called upon to help to demonstrate which PHI is processed by which system for PHI management. To assist with PHI management TrakCel consulting services will audit all supply chain systems used (both electronic and paper) to identify and catalogue where and to what extent PHI is processed to produce a data processing diagram for an organisation. These diagrams will inform GDPR/HIPAA compliance strategies for companies processing and sub-processing PHI.

Our cell and gene consultants will also provide information on how PHI/PII may be used as part of the COI strategy and how to address GDPR/HIPAA legislation when using PHI/PII for the purpose of COI management, and how to apply aspects of data management including consent, the right to be forgotten, and data processing limits.

Label Design and Compliance

Personalized advanced therapies have a heavy reliance on clear and compliant labels to ensure patient safety. Through offering cell and gene therapy consulting to many therapy developers, our consultants have worked within a range of compliant formats for globally distributed therapies.

Our consultants will aid with label design for clinical and commercial supply of ATMPs, this will include label design for both starting material and drug product to be included in CTAs and commercialisation applications.

Our consultants have extensive experience at all phases of clinical trial and commercial deployment and as such can help with labelling in preparation for IND, BLA, CTA and MAA applications.

Supply Chain Risk Assessment

A supporting document that is often overlooked for BLA and MAA filings is a supply chain risk assessment. TrakCel Consulting Services can offer several experienced cell and gene therapy consultants to work with you to review your full supply chain from collection to drug product administration. Our team can produce a Failure Modes Effects Analysis (FMEA) for advanced therapy supply chains.

The FMEA will inform therapy owner’s strategies for addressing risk when supplying advanced therapy products.

SaaS within Pharma

Our ATMP consultants have seen use of Software as a Service (SaaS) systems within the pharmaceutical industry increase significantly over the last few years, with a move from on premises data storage to cloud storage. However, approving the use of SaaS systems presents pharmaceutical companies with a new challenge which goes beyond typical GxP principles.

Reaching beyond our cell and gene therapy consulting services portfolio, we can offer pharmaceutical companies using SaaS systems access to experienced quality professionals with a strong background in SaaS solutions. This team can assist with SDLC auditing, SaaS system validation, and Quality assessments for vendor assessment/vendor management.

COI Strategy & Methodology

Chain of Identity (COI) and Chain of Custody (COC) are critical to ensure safety and quality compliance through the personalized medicine supply chain.

Data Protection Compliance

We understand how to manage COI whilst keeping Protected Health Information (PHI) secure.

Label Design & Compliance

Label design and layout are key to compliance and requirements can vary regionally. We work to ensure label templates can be controlled centrally.

Supply Chain Risk Assessment

Identifying and mitigating risks in the supply chain to minimize errors, waste and recalls to ensure successful filings.