Controlling CGT Data Accessibility 

Cell and Gene therapy (CGT) supply chain generally requires that many parties work together to ensure that actions such as patient registration, cell collection, logistics and manufacturing can all happen seamlessly to deliver a therapy in the minimum amount of time possible. As a result there is a vast amount of CGT Data generated within the supply chain, even where these tasks are consolidated under a single provider, and there are still many departments and users involved in the process, all with different roles and functions.

Personalized CGT supply chains are also relatively unique as there is a need for the patient themselves to become part of the CGT supply chain. The need to harvest cells from a patient or match treatments very specifically to patient genetics mean that consideration of how sensitive personal data is handled in the supply chain.

To reflect this and to ensure that CGT data is both protected and available quickly to those who need it to progress the therapy journey, whilst ensuring the system is easy to use and to reducing the opportunity for errors, OCELLOS uses specific user persona profiles. These personas reflect a specific function within the therapy journey and are tailored to ensure that the most relevant information for that user’s function is most accessible. This ensures that the user interface for each persona is configured to assist them in the tasks they are undertaking with minimal training burden.

These persona’s are critical to data protection and data accessibility as they control what can be seen, edited or deleted by a user, whilst ensuring that there is only one instance of the data occurring. For example, in a paper based system, in order to send redacted data to a courier partner for example, an additional document has to exist, and in this duplication there is both inefficiency and the opportunity for data errors. Within a digital COS, each user sees selected fields from the main record and these are updated in real-time, so if something changes, everyone who needs to know can see immediately.

There are other advantages to the field-by-field permissions that are set, they can assist you with protecting patient privacy and data processing compliance. You also have the flexibility to configure which notifications a user sees and the processes that they are able to undertake. This is particularly useful with non-reversible actions such as cancellation of a treatment as these can be restricted to a very small proportion of users with others only able to ‘pause’ or ‘flag’ that the action might be necessary. This in itself can reduce errors that cost time, money and may compromise patient safety.

By accurately mapping the data requirement for each user in the therapy journey, OCELLOS can even help to manage very specific processes, such as those that need independent, ‘blind’ verification of critical decisions within the therapy journey. In these instances, the system can manage the users in the decision making process and the flow of tasks between them and well as selecting the information that they are presented with.

Striking the balance between a customisable COS that can match your therapy, organisation and processes precisely and a system that is cost effective to maintain and update as needed can be tough. TrakCel have poured 10 years of experience into creating OCELLOS to strike this exact balance. Configurations are easily made and changed without the need for custom code that is expensive to maintain.

Next Week: Getting more out of notifications