Winning at Global Study Start-Up

On your mark…get set…bang!

A version of this phrase marks the start of virtually every type of race within the sporting world, whether it’s running, swimming, cycling, or anything else. Each athlete competes against time to get an edge over the other competitors, to get out front. The difference between winning and losing is often a matter of milliseconds. It takes years of constant practice and refinement (combined with a bit of luck) to gain that edge that could mean the difference between the gold and silver medal.

Product development in the life sciences industry is not all that different. While it may seem wildly dissimilar on the surface, drug development—like sports—is about trying to beat the best time and scoring when it counts. That incremental difference between the first place spot and everyone else in the field can result in lives saved or a drastically improved quality of life for countless patients.

Just like in sports, product development takes years of practice and refinement. Every day, hour, or second shaved off the process reduces the time to market, which means patients get the drugs they need faster and manufacturers have more money to invest in the next breakthrough treatment. In the clinical development phase that takes up a significant amount of the product development time to market, companies are always looking for innovative ways to save time. One area where process refinements can provide significant impact is study start-up.

Sponsors get the green light for study funding then—bang!—study start-up begins. Speeding this process allows subject recruitment to occur as quickly as possible so final analysis of results can be accomplished in a shorter time frame. CROs (when sponsors outsource the studies) compete to win the opportunity to execute these studies, routinely promoting why they have refined the process, why their process will win the medal.

Refining the study start-up process is particularly challenging for global studies, as there are many factors that impact the activation of investigative sites, such as:

• Country regulatory requirements
• Ethics committee reviews (which, depending on the country, can take place on the site level or on the regional level, and/or involve multiple review committees)
• The contracting process at the institutional or investigator level
• The translation of any documentation required by the regulatory agencies and/or ethics committees

Sponsors and CROs who’ve learned how to get out of the study start-up gate as rapidly as possible on a global scale have the best chance of ensuring products are first to market. With our vast knowledge of country translation requirements and a full suite of study start-up services and e-clinical solutions, TransPerfect can help companies get the edge in the product development race.