ARTiFACTS Verify: Blockchain-based Platform for Monitoring Drug Quality across Pharmaceutical Supply Chain

NIX created a unique platform, ARTiFACTS Verify, designed to track chain-of-custody throughout the entire drug supply chain, all in one spot.

Business Domain

Pharmaceutical
Service

Blockchain, Web Development
Technologies

Python, Django, PostgreSQL

Business Overview

The client, ARTiFACTS, provides platform solutions designed to validate evidence for science and commerce, aiming to enhance the research ecosystem and increase drug safety in low- and middle-income countries (LMICs).

The client came up with the idea to create a full-fledged platform to track and monitor the quality and safety of pharmaceutical products entering the market and inform mitigation action for stakeholders, including pharma manufacturers and distributors, regulatory agencies, and healthcare providers. The concept grew out of the need to reduce the number of substandard and falsified (SF) drugs in LMICs, which currently stands at about 10% and significantly undermines public health.

We had previously collaborated with ARTiFACTS, so they turned to us right away as a vendor with well-established expertise in software development.

Challenge

Our goal was to create a platform, ARTiFACTS Verify, which has no analogs in the pharmaceutical domain, designed to track chain-of-custody throughout the entire drug supply chain all in one spot.

We had to deal with the following challenges:

01
Build extensive business logic for data processing and synchronize, merge, and unify fragmented data from numerous sources to work as a single unit, such as laboratories, universities, and government agencies from different continents.
02
Implement blockchain technology into the system, a breakthrough solution for the niche that ensures the immutability of records and the chain of custody.
03
Perform third-party integrations with mobile in-field drug testing devices.

Solution

The NIX team created a web application hosted on AWS, in which the process for identifying and reporting on SF prescription products was the following:

The Platform Features

The functionality of the platform comprised the following:

The system covers data processing from in-field collection and quality screening to confirmation assessment and reporting to stakeholders.
Data about samples’ lifecycle, task results, and actors of drug testing are recorded in blockchain to create an immutable record and chain of custody vital to drug verification.
The platform is integrated with the Paper Analytical Device (PAD) reader and allows to add data from assays (HPLC and LC/MS), screening tests (MINILAB test, near infrared test). Shortly, monographic tests and root cause analyses will be added to the system.
Each sample type is analyzed following algorithms prescribed in the protocols we created and implemented into the operating system.

The set goals were achieved through the following steps:

Data Consolidation

The ARTiFACTS Verify system had to collect and consolidate tons of data into a single database. This is conditioned by the fact the client engages analytical testing labs in the USA, Ethiopia, Kenya, and Malawi into drug testing processes and continues to expand its geographic reach. Data tracking and monitoring are accomplished by connecting central, collection, and college labs with regulatory authorities like the Ethiopian Food and Drug Administration (EFDA).

We developed extensive business logic, binding and synchronizing all the stacked records from different sources. Flexible and consistent processes ensured stable and timely release of data processing status and accuracy in the display of final results.

Data Trustworthiness and Security

The NIX team deployed a blockchain node with developed smart contracts connected to the Bloxberg blockchain network. Smart contracts govern transactions for validating and verifying before appending them to a ledger. Leveraging a distributed ledger provides an irrefutable chain of custody in real-time for data such as records about samples, delivery packages, actors, tasks, locations, etc.

We created two independent services with their own databases and Redis as an event bus:

Blockchain broker stands for transaction processing
API, we developed, handles business logic, works with authentication of web and mobile clients.

Staff works on the distributed responsibility principle. For this, the platform envisaged certain roles for participants with different access rights—admin, site manager, inventory manager, and laboratory assistant.

Integrations

Our experts enabled data processed by the newest laboratory equipment to run through the platform and be stored in the cloud. Testing via PAD, an effective screening tool for drug testing in-field, supports upwards of 40% of WHO Essential Medicines. We made integration with the client’s PAD-reader iOS application, in which user authentication is executed through QR-code scanning without signing in via login and password.

Shortly, it is planned to integrate temperature sensor tracking devices needed for temperature control during the shipment of temperature-sensitive medicines, such as chemotherapy drugs, and integration with an Android version of the PAD-reader.

The Platform Architecture

Benefits of ARTiFACTS Verify

Fully automated tracking of drug quality across the entire pharmaceutical supply chain all in one spot with 100% veracity and preservation of data
Guaranteed veracity of provided data due to implementation of blockchain technology
Ability to conduct in-field drug screening with almost instant results provided by the integration with the PAD-reader
Simplified communication between the chains
Testing of different types of medicines, from generic drugs to ones with specific transportation and handling requirements
Ability to embed the platform at key stages in the supply chain, including when prescriptions are dispensed to patients
Relevance of solution to attract pharmaceutical, healthcare, and regulatory industry clients around the world

Outcomes

The NIX team helped the client to create a full-fledged platform for monitoring the pharmaceutical supply chain and controlling the quality of medical drugs coming onto the market. ARTiFACTS Verify decreases the amount of SF products influencing the situation on the state level and increases the overall public health in LMICs for now and in the near term worldwide.

The pilot product rapidly attracted the attention of different pharmaceutical representatives. At the moment, ARTiFACTS Verify has already partnered with 15+ organizations, including laboratories, universities and public health regulatory authorities.

We continue to work on the project to expand the functionality of the platform. In the near future an AI-based neural network, already invoked for generic medicines, will be enhanced to provide real-time and actionable analytics for many other active pharmaceutical ingredients.

Team:

12 people (1 Project Manager, 1 Business Analyst/Product Owner, 1 Architect, 1 Lead Engineer, 3 Full-stack Engineers (Python + Frontend), 1 UI/UX Designer, 1 Markup Engineer, 1 DevOps, 2 QA Engineer)