Customer Information about Coronavirus disease (COVID-19)

In line with all global organizations, Clinigen continues to actively monitor the developing situation with COVID-19. We are following the guidelines set out by the WHO, government, and health authorities. We also need to adhere to any government decisions made on COVID-19.

For our business continuity and ability to maintain our service, we are maintaining an awareness internally around managing risk, providing appropriate support in all our regional offices, and monitoring business travel requirements globally. Wherever possible, employees are guided to work from home and utilize VC/TC technology for meetings. For client visits, we are managing them by re-scheduling or using technology to support the visit. At this time, due to local guidelines in each country, we are not able to support site visits. This is to protect our team members as well as our clients. We do offer virtual tours and audits at certain sites to assist in meeting critical timelines.

With relation to outbound and inbound movement of products, we continue to monitor on a daily basis all regions & countries impacted by COVID-19. We are working closely with our courier network to identify any alternate lanes which can be utilized where there may be a risk in product delivery to the investigators and, ultimately, patients. The movement of products and materials in and out of India has been hampered by the closure of the entire country. Where we source comparators and co-therapy medicines, these are, predominantly, from US and EU manufacturers that have, likewise, not reported issues to this effect yet. Still, we are expecting some product shortages and delivery delays. The couriers across the industry have indicated they are applying a corona surcharge to shipments.

For your projects and studies, there is no impact on supporting your patients’ needs at this time. Our implementation of 2 shifts and A&B teams for risk mitigation with other sites having implemented extended shifts with overtime to meet our clients and their patients’ needs continues to go well. Also, please take into consideration that the worldwide and country-specific situation is changing on a daily/hourly basis, and shipments may be delayed due to the travel restrictions and border closures, airlines canceling flights, trucks waiting at borders, etc. So, in general, we should all consider additional delays for and/or during shipping. Our Project Managers will contact you to review resupply strategies. Shipping requests should be sent earlier to allow more time for potential delays or delivery difficulties.

CSM is also supporting several COVID-19 studies with very short timelines, in addition to studies that require a hybrid model for Direct-to-Patient support, including depot to patient and site to patient shipments. CSM will continue to provide regular updates on projects unless something specific needs to be addressed and shared. Of course, all Project Managers will update their customer contacts on new information or any potential risk for a specific project.