An update on our response to COVID-19

20 March 2020

Dear Customers, Colleagues and Collaborators,

As we all do our part to flatten the curve during this pandemic, Cogstate remains fully dedicated to supporting clinical trials, continuing to respond flexibly to the needs of participants, investigators and sponsors and ensuring the safety of all involved. We have implemented a COVID-19 response team who have activated business continuity strategies, including the following:

All non-essential staff are working remotely with complete connectivity:

A strength of our global workforce is our flexibility. The great majority of our teams, including our consulting clinical experts, are fully equipped and adept at operating remotely, minimizing any impact to project delivery during periods requiring office closures or travel restrictions. Our IT infrastructure and global communication platforms support ongoing, real-time communication and collaboration, whether working in an office or remotely.

All non-critical travel has been restricted – we are coming together using virtually-enabled platforms:

We are successfully leveraging technology to continue to meet business challenges and work collaboratively to deliver towards our shared objectives. We value the time spent connecting with our customers and sites and we are committed to finding new ways to foster connection and support throughout this unprecedented challenge.

We are advising sponsors on strategies for clinical trial assessment schedules:

Our clinical science and operations teams are working closely with sponsors and investigators on considerations and action-plans for the clinical outcome assessments in upcoming and ongoing studies. We are exploring together the feasibility and implications of factors including changes to the mode of test administration such as video and telephone administrations, as well as statistical analysis methodologies for addressing missing data. Each trial and each clinical outcome assessment have unique characteristics that make this determination multi-factorial. Our teams will continue working with sponsors to find innovative solutions to any and all challenges to the development of new therapies. The FDA Guidance on the Conduct of Clinical Trials During COVID-19 Pandemic, is an important step in ensuring that clinical trials continue with minimal disruption during this time.

We are proactively mitigating supply chain disruptions:

Cogstate, together with our eCOA partners, are taking every precaution to secure supply chains for the provisioning of tablet devices and other study materials during this time. We have in-house logistics teams which are currently operational in Connecticut (Cogstate), Philadelphia and North Carolina (Clinical Ink). In addition, we have service agreements in place with leading third-party logistics and fulfillment providers, supporting both US and international shipments from locations across North America, Europe and Asia Pacific. As a precautionary measure we are working with suppliers to ensure sufficient hardware inventory to meet projected study demands, and we are pursuing earlier shipment dates from our standard lead-times by country.

 

Should you have specific questions, please reach out to your Cogstate project manager or business contact or via our website.

We will continue to provide updates as the situation evolves.

 

Stay safe and be well,

Brad O’Connor
Chief Executive Officer, Cogstate Ltd.