Gerit Offenhauser, VP of global business operations at Clearstone, told Outsourcing-pharma.com that although all employees are safe and have been accounted for, the impact on operations has varied across the country.
“Given the magnitude of this event and loss of life, the impact to clinical trials in northern Japan is significant while in southern Japan we are beginning to see patient visits and collections returning to normal.
He added that: “No trial has been halted so far, but virtually all trials with activity in Japan have been impacted in some way.”
Some 4 per cent of Clearstone’s investigator sites are in the Miyagi and Akita prefectures, which were the areas most severely hit by the tsunami, with a further 20 per cent in regions that have suffered damage to transport and communication infrastructure.
“The remaining sites,” Offenhauser continued “are in locations that are not directly impacted by the disaster, but are now facing challenges such as power outages as well as transportation delays with priority given to disaster recovery efforts and humanitarian aid supplies.
“In addition, the latest developments of the nuclear danger will impose an additional burden to the infrastructure as more and more people evacuate south.”
The picture was similar for Quintiles, which told Outsourcing-pharma.com that all 2,400 of its employees in the country were safe, its facilities had not been damaged and that its priority now “is to safeguard the patients in our studies.”
“Clearly a disaster of this scale does impact on studies however we do have a process to mitigate any impact. We have reviewed all ongoing studies, prioritized those in the active treatment phase and alongside our customers are reaching out to support investigators and sites in the affected area.
“In addition we are looking to maintain clinical trail supplies across the whole country and to ensure all laboratory samples are processed appropriately.”
The firm added that it “is developing an aid fund to which employees from the rest of the world can contribute to support their Japanese colleagues directly affected by the earthquake.”
Charles River Laboratories also told Outsourcing-pharma that its employees were safe and its five facilities in the country had come through the earthquake “relatively unscathed.”
The firm added that: “We are working with our Japanese colleagues and clients to evaluate and monitor the situation. We anticipate that we will experience some disruption in our Japanese operations as the country and our clients respond to the aftermath of the earthquake and tsunami.”
Icon also said that its employees have all been accounted for but added that those in Tokyo are working from home following the closure of its office. The firm’s Osaka office is still operational.