Reducing Complexity in South African Clinical Trials: New Importer of Record Framework from Oximio

Running a clinical trial can often be fraught with difficulty and can be a complex process, particularly when it spans multiple countries.

This couldn’t be more true for those conducting clinical trials in Africa. Bearing the largest disease burden in the world, the continent spans 54 countries, each with their own set of regulations and multiple language barriers to overcome.

Among the many crucial components that ensure the seamless execution of a clinical trial is that of the role of Importer of Record, IOR, who plays a pivotal role in ensuring the smooth running and success of a clinical trial.

Transcript:

Hello and a warm welcome to Oximio Voices, this is Oximio’s podcast series, where we bring you the latest updates from the world of clinical trials and supply chain management.

In today’s episode, we’re going to explore some of the significant developments regarding Oximio’s operations in South Africa, notably a recent strategic update on the importation of clinical trial material.

We’ll look at the impact this will have for clinical trial sponsors, CROs, and other stakeholders involved in clinical trials in the region.

We’ll break down the key updates, the benefits to clients, and the implications for the broader clinical trial landscape.

I’m Alison, Communications Specialist at Oximio.  And joining me today to discuss these developments is Wilrian Brummer, Regional Business Development Manager for Oximio in sub-Saharan Africa.

Welcome, Wilrian.

Thank you, Alison.

Wilrian, by way of explanation, just to start us off, could you perhaps give us a brief overview of this latest and significant update from Oximio?

Absolutely, Alison. And thank you so much for having me on the podcast.

It’s great to be here.  Thank you.

So this is a really exciting update from Oximio that I believe will make a big difference for sponsors and CROs operating in the region.

The big news is that Oximio, South Africa or Africa is now officially stepping in as the Importer of Record or IOR, which is how I will refer to this, going on in chat for all our clinical trial material and shipments.

Now just to clarify for our listeners and for the viewers, the IOR is the personal entity responsible for ensuring that goods are imported in compliance with local law and regulation.

That includes the handling of all customs paperwork, duties, taxes, you name it.

It’s a pretty crucial role, especially in something as regulated and sensitive as clinical trials.

This means that from now on, Oximio will handle IOR duties for everything, from investigational medicinal products to named patient materials, lab kits, medical devices, and more.

We are able to provide these IOR services in most sub Saharan African countries, including South Africa, Kenya, Namibia, just to mention a few.

And the best part, is we’ll now be officially recognised as the IOR in regulatory submissions to SAHPRA, the South African Health Product Regulatory Authority.

So this isn’t just a behind the scenes change.  It’s a full assumption of responsibility on our part to make sure customer clearance runs smoothly and that the materials get where they need to go without any necessary delays or hiccups.

Who wouldn’t want that? So how does this new IOR framework work in practice? What would you say are the core responsibilities of Oximio under this new model?

That’s a great question. In practice, what this looks like is very straightforward, on the surface at least.

We’ll be managing the full custom clearance process. Once those materials are cleared, we’ll take care of the delivery right to the client site or warehouse.

But there is a bit more to the structure behind this. We also put in place a formal letter of delegated authority with each trial sponsor.

This document lays out who’s responsible for what, especially around logistics, so everyone is clear from the start.

So this framework helps avoid confusion down the line, especially around who owns the material at what stage and who’s liable if any customs or shipping issues arise. It’s about giving our clients peace of mind that we have their backs on the ground.

That’s a huge, convenience for customers to have that complete peace of mind. So we could say therefore, this a bit of a game changer for Oximio’s customers. Perhaps you could dive into the customer benefits then for the trial sponsors, the CROs, and other stakeholders.  What are the key advantages of this new system for them?

 Yes. You’re right. I mean, this is a real step forward.

 You know, one of the biggest wins here is probably cost predictability.

Clients will now know exactly what they’re in for from the start.

There’s no surprise expenses popping up related to duties, taxes, or extra import fees.

It just takes a lot of the guesswork out of the budgeting process. Things are just simpler.

The whole import process, customs regulations, the mountains of paperwork, all of that is handled by us as the IOR.

So clients can focus on what they do best, and that’s running the trial, and we’ll handle all the bureaucracy.

Then there’s risk reduction. As the IOR, Oximio takes on the legal and financial responsibilities of getting that shipment into country.

So clients aren’t really left dealing with compliance issues or legal complications.

And then finally, this is a huge time saver. With us managing the whole process and piece, sponsors and CROs don’t have to get tied up in the red tape.

It allows the team to focus on their work rather than chasing customs agents or clarifying import documentation.

Exactly. So that sounds like a major improvement. What about VAT management? That’s often quite a concern for stakeholders involved in trials.  And also, how does this new framework benefit local CROs and sites?

Yes. VAT is always a hard topic. Right?

So under the new model, we also take care of all the VAT payments on behalf of the sponsor.

Then we recover these costs in a structured and amortised way, which keeps things manageable and, most importantly, transparent.

This is where it gets even better. Local CROs and trial sites benefit directly too.

In the past, they often had to cover these VAT and duty payments upfront just to get the shipment cleared. That’s a massive cashflow burden for them, especially for the smaller sites.

So with the new IOR structure, they don’t have to carry that weight anymore. It reduces the financial pressure, and then it helps avoid any shipment delays at customs due to payment issues.

So it’s really a win win.

Finally, Wilrian, as we go forward looking ahead, how do you see this change impacting service delivery and client satisfaction in the long term?

Honestly, I see this as a real game changer for how we deliver our services going forward.

You know, by taking on the IOR role, we’re cutting down on a lot of the delays and complications that used to creep up during the customs and VAT processes.

Everything just becomes more centralised, more streamlined, and that means fewer headaches for our customers and clients.

This also means better planning, better communication, and ultimately, smooth trial operations.

From what we’ve seen already, when these pain points are removed, client satisfaction really improves.

It’s all about helping our partners moving faster with fewer surprises and more confidence in the process.

And that’s really ultimately our goal.

Yes.  Our customers are our number one priority.

So thank you so much for sharing these informative insights.

It’s clear that the updates will significantly improve the process within South Africa, benefiting sponsors and stakeholders right across the board.

And for any of our listeners wishing to learn more about these changes or how we can support your clinical trial in South Africa, then Wilrian is the person to reach out to and we have a contact information page on the website where you can put a message in there and get hold of him.

He’ll be delighted to discuss any requirements that you might have. So thank you once again, Wilrian.

Contact

Wilrian Brummer, 
Regional Business Development Director, sub-Saharan Africa,
Email: wilrian.brummer@oximio.com