Global Trials

January 1, 2009

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-01-01-2009, Volume 0, Issue 0

As patient recruiters and sponsors face low recruitment numbers, they must look beyond global trials to find a solution.

Patient recruiters are handling more and more global trials each day, and the transition is happening quickly. Along with sponsors, they're depending on globalization to reverse the trend of low recruitment numbers that often lead to trial delays. Sure, globalization increases access to more prospective patients and means less competition among other clinical trials looking for similar participants. But going global is anything but a cure-all.

Steve Horstmann

Global trials can open up a whole new world of complexities for recruiters, particularly when it comes to the logistics behind recruitment and retention materials. These materials are powerful educational and marketing tools that help reach the public and retain participants. Their timely delivery can mean the difference between prospective patients having the info they need to learn more about a trial when they are most receptive and a lost enrollment opportunity.

Global gripes

Why do the logistics of these materials pose such a problem for global trials? To start, different languages and cultural nuances lead to multiple versions of the same materials. This adds an extra layer of organization to properly manage the materials. Also, approval for materials from ethics committees in different regions may have varying timelines, making planning more challenging.

Another struggle is clearing customs. With each country having its own specific regulations, it's easy to overlook required documentation. This often leaves materials undelivered until customs officials reach an appropriate contact and arrange to receive the necessary paperwork. Clearing materials can sometimes take weeks.

Historically, many clinical trial and patient recruitment managers have relied on general print houses, fulfillment providers, and warehouses to service their needs and coordinate the delivery of these materials. As a result, they've experienced production and coordination delays, holdups in customs, and even the delivery of materials in the wrong language. But in a time when CROs, SMOs, and patient recruitment firms continue developing their own specializations, shouldn't they look to partner with other niche providers?

The outsourcing model for clinical trials is most effective when industry experience influences vendor selection. It makes the most sense for organizations tasked with trial management or patient recruitment to rely on specialized vendors that bring their know-how to the table.

Patient recruiters should rely on a specialist to improve their overall supply chain process for the global delivery of recruitment materials. As trials expand worldwide, a specialized materials management provider with global experience can navigate through challenging approval timelines, multiple versions, customs requirements, and carriers without unexpected delays.

Experienced specialists also recognize the importance of being connected to project managers all over the world. They use sophisticated Web-based technology to provide easy fulfillment management, automate global team communications, and manage multicountry versions. The result is the ability to provide sponsors with the flexibility to maximize their global recruitment and retention strategies. By turning to specialized vendors, patient recruiters can stop juggling concerns about sites receiving accurate materials on time.

Related Content:

A Closing Thought | CRO/Sponsor