The Future of Clinical Trials with PharmaLedger
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The Future of Clinical Trials with PharmaLedger

There is a lot of hope these days as the first coronavirus vaccines sprint to the finishing line of their development process and enter the distribution phase.

The entire process is very complex and costly, and faces many challenges. But even so, it’s been much accelerated by one thing: experts, governments, and companies working together at a pace and intensity that were never seen in recent history, towards the common goal to end the pandemic.

A blockchain powered clinical trials supply chain process

Now that we’ve had a glimpse of where cooperation can take us, let’s use the vaccines development example above to illustrate how blockchain-powered project PharmaLedger can improve the future of clinical trials supply chain process.

Currently, the simplest version of a clinial trials supply chain looks like this:

clinical trials supply chain process
Clinical trials supply chain process

Current pain points across the chain

If we look at the process to develop a new vaccine, we can see there are currently several pain points along the clinical trials supply chain. These make the procedure sinuous, costly and time consuming:

  • There is no instant, full transparency at any check point. Multiple operations, paperwork and a lot of time are needed to track a product back to the manufacturer.
  • Every stakeholder is burdened by a lot of paper work and manual data processing
  • Each stakeholder only has visibility one level up and one level down the chain. This makes the authorization process especially a lot more difficult than it should be.
  • Data is siloed (is processed in apps and databases that are not interconnected)
  • Data is easy to falsify

Can blockchain address these problems? Rather than looking for a more technical explanation, let us delve into how PharmaLedger will improve the activity and workflow for each stakeholder involved in the clinical trials supply chain process.

Why put it on the blockchain

Suppose that Ray, Doug, Penny, Warren, Lynda, Clive and Patty are the main stakeholders of the clinical trials supply chain environment. Here’s a peek into how PharmaLedger will improve their work at each level.

Raw materials manufacturing

Ray is a raw materials manufacturer. He supplies the raw materials from which the primary product is made. The PharmaLedger blockchain gives him real time, end to end visibility across the entire clinical trials supply chain. He can see product consumption across all drug product manufacturers and adjust supply with demand in due time.

Drug product manufacturing

Doug is a drug product manufacturer. Like Ray, Doug has end-to-end real time visibility across the chain. Timeframes are shorter and more predictable, wasted product reduced. The cycle to discover new medicines and put them on the market is greatly accelerated, and in a safer way.

Packaging & labelling

The role of Penny from packaging and labeling is crucial for tracking the chain’s integrity. Using the 2d data matrix printed on each package, the product can be uniquely identified and traced at any check-point. No matter where the product ends up, everyone can check its authenticity.

Also, at the clinical site, Clive will be able to pair a patient to the unique product they receive for treatment. Why is this important? For example, in case adverse effects are reported, he will be able to track back the product and see if data correlates to a specific batch for example.

Warehousing

Sometimes pharmaceutical products have a special storage regime, as is the case with some of the new coronavirus vaccines. The very low temperature conditions required are difficult to maintain. In this respect, Warren’s life in warehousing just got a lot more complicated.

But luckily, with the new PharmaLedger technology, Warren has the possibility to create and manage a super controlled environment via IoT devices on blockchain that will monitor temperatures on a permanent basis. Also, he will know exactly which products have been compromised in case a problem arises, and which ones have been kept safe.

Logistics

We already hear news of counterfeit Covid-19 vaccines making their way into the market and this will be a rising problem in the next 6 to 12 months. With blockchain technologies, Lynda, in logistics, has more control of all transports being shipped to the right place and not being diverted or replaced. Also, red flags are raised as soon as suspicious activities take place and immediate action can be taken.

Clinical site operations

By the time the vaccine gets to Clive’s clinical site, data records on its entire journey are safely anchored to the PharmaLedger blockchain. Clive doesn’t have to trust the system blindly. The value comes from the fact that the entire process is traceable and data is immutable. If errors are made, they can’t be covered up. With a few simple checks anyone can make sure the product is authentic, that it has been stored properly and transported in optimum conditions.

Patients

From Patty’s point of view, who is a voluntary participant in the clinical trial, having the entire process built on the PharmaLedger’s layer of trust is reassuring. She doesn’t need to be aware of the back-end processes or the underlying technology. She just needs to know that on blockchain, data cannot be manipulated, that there’s fast reporting of clinical results over the entire chain and that real time corrections are made at every level.

Empowering the patients, being closer to them, and ensuring that they are treated the way they should be, that is exactly the vision of PharmaLedger. And this cannot be done by relying on the on-paper based processes, or disrupted IT solutions, but by integrating the process on a single source of trust that is shared across the participants.

Quick recap

Summing up, some of the main arguments we have today for moving the clinical trials supply chain process to the PharmaLedger blockchain based environment include:

  • Supply chain integrity
  • Real time data visibility at any check-point
  • A single shared understanding of where a product is in its lifecycle
  • Less time/lower costs to develop and approve a new drug/treatment

This, of course, is no instant process. There’s a big effort involved and a lot of steps to be made. 2020 was the use case definition and foundations year. As of 2021 we have entered the design and development phase. The teams assigned for each use-case will focus their energies in order to have their functional MVPs ready by June this year.

Zooming out of small details, PharmaLedger brings together 12 global pharmaceutical companies and 17 public and private entities. These partners are working side by side to provide a widely trusted platform that supports the design and adoption of blockchain-enabled healthcare solutions and accelerate innovation that benefits the entire ecosystem, from manufacturers to patients. This is certainly the kind of project that’s worth keeping an eye on.

Further reading

Next on the PharmaLedger use cases list we’ll talk about the finished goods traceability and the anti-counterfeiting solutions that are in line for implementation.

If you missed the first feature in this series, you can read it here: eLeaflet use-case.

Iulia Weingold
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Iulia Weingold
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