According to the company, the depot will now be able to legally perform several new activities.
“The pharmaceutical license allows the storage, handling & distribution of commercial drugs not only within the framework of clinical trials, but it also provides Marken the option to act as a wholesaler, perform labeling operations, manage cytotoxic, highly potent substances and controlled drugs (IV-V Schedules RU),” Sascha Sonnenberg, VP global CTD sales & operations, told Outsourcing-Pharma.com.
Securing a license is a four to six month process and requires three Federal Healthcare & Sanitary Inspections.
In December 2015, Marken announced the grand opening of the depot in Moscow, Russia – a market which is seeing fast growth.
According to a report by CRO Smooth Drug Development, 70% of new drugs registered in Europe in 2015 were tested in phase II-III clinical trials in Russia, with phase I and II trials accounting for about a quarter of all clinical trials in Russia.
“Russia offers access to patients, who are eager to participate in clinical trials in order to get access to new therapies, and established processes and timelines for regulatory approval,” Anastacia Kurianova, CTD country depot head & technical director told us.
Clinical trials in Russia
While the industry is on the rise in the country, the challenges of conducting clinical trials in Russia are not to be overlooked, said Kurianova.
“Consider, for instance, the large geography of Russia, which increases the time to reach patients and the accessibility of patients themselves who are participating in trials, which becomes of particular importance in whether to include Direct to Patient service as part of a trial,” she said.
“Can your patients reach an investigator site easily? Can biological samples be obtained and speedily transported to a lab?” she asked.
Additionally, the temperature ranges faced during pick up, transportation, and delivery across the country can vary greatly, “so it’s critical to have the right packaging solutions in place for all scenarios,” said Sonnenberg.
Drug imports and Customs clearance can also cause delivery delays if the proper paperwork and document translations are not managed.
“The benefits of building and operating a Marken depot in Russia allows us to make the best use of our validated packaging solutions for clients,” added Sonnenberg.