Global Growth Plans – Three ‘L’s You Can’t Forget

Expanding your operations to a new country is a thrilling time, exposing you to new markets, new opportunities and new trial participants. But you need to approach the challenge strategically, considering three crucial aspects: logistics, local regulations and local support. Tackle all three and your move or expansion will be as painless as possible.

Logistics

Clinical trials are increasingly global in nature. As one of the world’s leading suppliers of clinical trial supply chain support, we recognize the significant logistics challenge of running multi-site trials.^[1] Working with a new site in a different country is a complex process. Specialized medical equipment and test kits need more than packing up and sending off; they need care and attention for the whole journey.

In our experience, it’s essential that you consider three elements of your move:

Cost: Establishing a new site is expensive, but that’s no reason to over-spend. Working with a trusted partner at-scale can minimize the expense.
Customs: Transporting equipment, materials and samples across borders is a significant challenge that’s best left to specialists. Managing customs challenges is an essential role of established global organisations like Therapak and their partner MESM. What’s the benefit of this?
Timing: The smooth running of your business demands timely and secure delivery of test kits and materials. Our global reach and established supply network can streamline the delivery process, ensuring speedy set-up and minimal downtime. What’s the benefit of speedy set up and minimal downtime? Business continuity? Minimal impact on commercially important operations?

No move is ever going to be stress-free and there are likely to be significant hurdles, however this can be mitigated by working with a trusted partner who understands the challenges you face.

Local regulations

Adapting to local regulations is a significant task, with global harmonization still a distant dream. In the US the Food and Drug Administration (FDA) provides a centralized and standardized process but across the Atlantic it’s a more confused picture. Currently the European Union operates a ‘network of centralized and decentralized agencies’.^[2] However this process is likely to be simplified to a degree by the introduction of the new EU Clinical Trials Regulations (scheduled for 2019).

Businesses expanding into emerging markets like South America, Africa and parts of Asia will not only face significant legal and regulatory challenges, but also “operational, infrastructural, language and cultural” hurdles too.^[3]

Working with a trusted and experienced partner can reduce the risk of exposure to new and potentially challenging legal and regulatory frameworks. Detailed local knowledge of systems, processes and regulations can help you to integrate successfully.

An investment in a new territory is significant and represents a long-term commitment. A global partner will have a deep understanding of the political climate and country specific compliance requirements, helping you to plan strategically for continued success in your new country.

Local support

Once your sites are identified and you’ve achieved regulatory approval, it’s time to start work. Developing a network of in-country suppliers is time consuming and challenging. You need the confidence that all quality standards are met and universally applied.

Many trials organisers prefer to work with truly global suppliers like Therapak and MESM who ensure equipment, test kits and materials are standardized. We’re investing in a new Center of Excellence, located near Prague in the Czech Republic. The heart of our custom kitting, global logistics and specialist supply chain services operation, this 35,000 square-foot facility adds to our Los Angeles and Atlanta supply bases. We have a significant footprint to support clinical trials across the world.

Experience and insight

It may be tempting to go-it-alone, but it’s difficult to fully absorb enough in-country knowledge to effectively support a brand-new territory. To successfully meet the logistical challenges, it’s essential that you identify partners to fulfill your global supply needs, ensuring on time delivery of key kitting supplies for your trial – especially when they have to be customized. Your vendor needs to support your logistics, be an expert on the local regulations, and have experience relevant to your target continent.

Finding a partner who can support you across these areas will alleviate the time, cost, and customs concerns which could derail your expansion plans. Find the right partner in the Avantor group so you can focus on making your trial a success. Therapak, EPL Archives and MESM are three arms of the Avantor Clinical Services organisation, a unique group of experts dedicated to assisting you in optimizing the progress of your clinical and commercial operations.

Therapak’s configurable kit manufacturing and distribution works in tandem with MESM and EPL’s service offerings to provide the meticulous care of on- and off-site samples. Together, the Avantor Clinical Services increase efficiency and standards of patient care across the research space. Considering this wide scale expertise, your global growth plans are in safe hands with the Avantor Clinical Services group.

[1] Clinical Trial Logistics | 10 Steps for Medical Study | Blog – MESM. (2019). MESM. Retrieved 30 April 2019, from https://www.mesm.com/blog/10-steps-to-help-manage-global-clinical-trial-logistics/

[2] Van Norman, G. (2016). Drugs and Devices. JACC: Basic To Translational Science, 1(5), 399-412. doi:10.1016/j.jacbts.2016.06.003

[3] Ali, S., Egunsola, O., Babar, Z., & Hasan, S. (2018). Challenges of conducting clinical trials in Asia. International Journal Of Clinical Trials, 5(4), 194. doi:10.18203/2349-3259.ijct20183748