“Marken’s clients continue to move to more areas to find suitable patients for their trials,” Dan Bell, VP Regulatory Compliance and Technical Affairs, told Outsourcing-Pharma.com, who gave the example of Orphan drugs, “for which it is more challenging to find treatment naïve patient population.”
The company announced it is expanding its reach to areas including Iran, Mongolia, the Azores, the South Pacific Islands, and other remote territories in Eastern Europe and Africa – “in compliance with all relevant regulations.”
According to the company, these areas continue to emerge as preferred locations for clinical trials because patients previously have historically been limited in their healthcare options.
Clinicaltrials.gov cites nearly 12,000 active clinical trials running in 72 African and Middle Eastern countries including Egypt, Israel, Uganda, Jordan, and Kenya.
Marken also uses tracking technology, such as the Sentry device and Maestro software, to secure data and shipments and support clinical trials in these regions.
“As trial design has become more complex, it is more difficult for our clients to find patients meeting the criteria, hence the obligation to include more remote areas of the world,” explained Bell.
According to Bell, typical challenges encountered in these remote areas include underdeveloped infrastructure, geopolitical stability, ambiguous regulatory framework, and training of local staff.
To overcome these challenges Bell explained that Marken has developed close relationships with local experts and “work[s] closely with local regulatory bodies to develop best practices.”