Impact of COVID-19

Informational resources including the latest policy, security and quality updates related to our COVID-19 response.

Study Sites, Monitors and Study Teams – Please view our device handling recommendations.


26 March 2020 

Despite some hopeful news around the margins, including infection rates slowing in a handful of countries, there is clearly much in front of us. Our goal, no matter how this situation plays out, is to continue to focus on open and transparent communication while supporting our customers as effectively as possible through this challenging time. With that end in mind, I wanted to send a short update to you.

We realize that many aspects of your business and the operation of research sites that support it are fluid, and we are, probably like you, rapidly adjusting to a new reality. At the same time, we are doing our best to respond to the many requests and questions we’ve received as you look at models to adapt your work in a difficult environment. Our goal is to be flexible and urgent while we deploy our people and technology to support you. This includes everything from unique and innovative ways to interact with patients, solutions to manage and collect data remotely, direct to patient shipments as well as adapting processes in order to meet short timelines in support of COVID-19 related trials, often without SOWs or contracts in place. For us, this is the time to simply focus on what we can do to help, to be a reliable partner and to live one our core values. We want to be counted on.

Perhaps it was inevitable, but this week we did have one confirmed case of COVID-19 within our Signant team. Thankfully, our teammate is doing reasonably well, and we believe our actions to move teams to remote work early on prevented any risk to other Signant employees. We continue to follow our Business Continuity Plan and its component Pandemic Response Plan, while remaining agile enough to adapt to unpredictable events and requirements. As part of that plan, most of our teammates continue to work remotely and, while we expect this to be the norm for some time, we continue to support our customers from all locations around the world. The situation is not ideal, but we believe a combination of putting our people first, providing flexibility, adapting our benefits where needed and ensuring that our technology infrastructure remains intact give us a high probability of success.

Today there are no significant limitations on capabilities in any part of our business, other than those directly related to travel, shipping or other restrictions. Supply chain for devices and other technology components continues to be unpredictable, but we have stock, due to some early actions, to carry us for an extended period if that is required. We are seeing, as I am sure you are, disruptions and delays in shipping, in part due to the reduction in capacity associated with passenger airlines.

We are proud to be supporting you in efforts to establish treatments, prevention, detection and vaccination for COVID-19. We are also energized by the work alongside your teams to establish capabilities in a very different research environment. Whether that is data monitoring, central reviewing and rating, patient engagement, adapted data collection or telemedicine models, we want to do whatever is necessary to preserve the integrity of your important work. We also believe that, while not ideal, we are learning – together – what is possible, and we hope that this experience accelerates long term innovation and collaboration on behalf of the patients who, more than ever, we stay focused on.

Thank you for trusting Signant Health and we wish you health and patience in the coming weeks.

Respectfully,

Mike Nolte
CEO, Signant Health

16 March 2020 

The COVID-19 outbreak continues to impact us all, and I wanted to provide another update to you as our customer and partner, on our actions in response.

To date, there are still no cases or suspected cases of COVID-19 reported by our teammates or their families. However, last week, as we assessed the situation, it became clear that acting ahead of any emerging health issue was required. As a result, last Wednesday we began planning to move to Level 3 in our Pandemic Response Plan across all Signant locations.

Level 3 means that today, all our Signant teammates, regardless of location are working from home or a remote location unless there are business critical reasons to be in an office. We are also carefully managing risk and social distancing in locations where remote work is more difficult. This is primarily our two logistics facilities in the US and the UK.

We worked hard to test our infrastructure and operating models ahead of this move, and in part, we chose to take this action now so that we have more flexibility to adapt to any unforeseen challenges before local or national restrictions potentially make that more difficult. This change does not imply closure of any Signant office, apart from our Tokyo location. It does mean that our teams will only be in our offices by exception. We have also placed further restrictions on both national or international travel, even where travel is allowed by government or other action.

As before, there continues to be some impact on business activities due to local events, e.g. import disruptions and transport delays, but otherwise we are operating normally.

Finally, in accordance with our Business Continuity Plan we’ve begun adapting some business operations in anticipation of different customer needs. This includes engaging with sites on impact to their operations, monitoring FDA, EMEA and other regulatory guidance and engaging with IRBs and ethics boards actively. Our goal is to be able to support changes to your business model wherever possible. This may include supporting content and delivery for remote meetings, implementing changes to data monitoring models, adapting logistics requirements or expanding use of remote assessments. We will certainly not anticipate every need so please let our teams know how we can best support you.

Thank you for partnership and we look forward to getting through this challenging time together.

Respectfully,

Mike Nolte
CEO, Signant Health

 

10 March 2020 

As the impact of COVID-19 continues to expand, I wanted to provide a further update on our response. My original message from last week is also included below for your reference.

Our principal concern continues to be the people who make up Signant Health’s community of employees, customers, and supply partners. To date, there are no cases or suspected cases of COVID-19 reported by our teammates or their families. However, we recognize the high likelihood that this can change without warning, and we continue to monitor our offices and our operations.

As mentioned in my prior communication, our Business Continuity Plan (BCP) is in effect and we are executing against our Pandemic Response Plan which is a part of that BCP. At the same time, we are remaining flexible enough to adapt to this real-world experience and to refine our execution as needed. Finally, we continue to proactively implement operational changes, to test infrastructure in advance of any potential disruptions and to secure inventory for critical business needs (devices etc.) in advance of current or future supply chain disruptions.

In accordance with out Pandemic Response Plan, on 9 March we changed our stance to be consistent with “Level 2” which, in addition to actions we have already taken, includes expanded guidance for our Signant Teams, expansion of work from home arrangements where prudent, and greater restrictions on travel, particularly international travel.

Tactically, our office in Tokyo, Japan, remains closed, and while all other Signant offices remain open, the number of our teammates working remotely continues to increase, partly due to local actions such as school closings and public transport challenges. Outside of our office operations, there continues to be some impact on our business activities due to local events, e.g. import disruptions and transport delays, but otherwise we are operating normally.

As before, I am available for your questions or concerns, as are the other Signant team members that you work with, and we are proud to be part of your important work, even in this challenging time.

Respectfully,

Mike Nolte
CEO, Signant Health

 

5 March 2020

COVID-19 has touched the lives of many people around the world, and I want to take an opportunity to personally update you on the actions Signant Health has taken in response.

Our principal concern is with the people who make up Signant Health’s community of employees, customers, and supply partners. This is a rapidly changing situation, and as it develops, we are continually reviewing the impact on our team members and on the work that we do with our customers. We will always start with taking care of the Signant Health team, and, at the same time, we are urgently focused on continuing to support you through this challenging period.

When the scope of COVID-19 became apparent, we activated our Business Continuity Plan (BCP), and we continue to implement risk mitigation strategies to ensure operational continuity and safe working conditions for our teams across the globe. We are also continually reviewing our BCP to make sure we are prepared ahead of time as new developments warrant. This includes ensuring access to our offices, our services and our equipment and device supply chains.

To date, Signant’s services, including delivery, logistics, help desk etc., are uninterrupted outside of government restrictions (e.g. shipping in and out of China remains challenging). We are also communicating with customers directly as necessary to adapt to their own BCP activities. As things progress, we may adapt how we provide services, but so far, apart from one office and some restrictions on travel, we are operating normally.

Where we have locations in countries with higher risk, we will, again, focus on putting our teammates first. To date, this approach has only impacted our office in Tokyo, Japan, where we have temporarily closed our facility and asked our team members to work remotely until it becomes clear that the risk profile changes.

We will continue to closely monitor this situation as is it evolves, and we will take additional actions as the situation warrants to ensure the protection of our team members and our customers. I am available for your questions or concerns, as are the other Signant team members that you work with.

Finally, a global health crisis like COVID-19 illustrates the power of the work you do every day and serves as a reminder to me and to our teams of how proud we are to be your partner. Thank you for that opportunity.

Respectfully,

Mike Nolte
CEO, Signant Health