March 19, 2020

Customers and Partners –

Like you, Clinical Ink is actively monitoring and responding to the rapidly changing situation related to COVID-19.

We recognize that you have entrusted us with your most critical study data. I want to assure you that Clinical Ink is well prepared to continue to support all active studies.

In addition to the below information, please reference the FDA guidance.

Critical Operations

Our critical tasks including Project Management, Study Build, Data Services, and Helpdesk are all performed by in-house employees. All employees, including the Helpdesk, are equipped to be able to work from home – and do so routinely already. As of Monday March 16, all employees except for Logistics are working from home and have complete access to all resources necessary to continue supporting our customers.

Our internal Logistics operation has redundant fulfillment capabilities, with locations in both our Philadelphia and North Carolina offices in addition to a third-party provider based in upstate New York. Clinical Ink has proactively secured sufficient hardware inventory to meet projected study demands through the end of 2020 in order to account for potentially longer supply chain disruptions.

Technology Platform

Clinical Ink’s technology platform is particularly resilient, flexible, and well-suited to function in situations like this. Specifically:

  • Our ePRO/eCOA solution has been used in over 40 “Bring-Your-Own-Device” studies involving nearly 35,000 patients over 2,000+ sites in the United States and Western Europe.
  • Our eCOA/Direct Data Capture solution enables true remote monitoring of both data and source documents; monitors can review data in real time without traveling to sites.

As you consider risk mitigation strategies, please keep in mind:

  • Most active ePRO studies could offer a “BYOD” option which would mitigate concerns about device availability due to logistical issues.
  • Many eCOA studies could easily be adapted to enable true remote monitoring simply by building extra forms.

We are available to consult on risk mitigation strategies as needed. Should you have specific questions about how your study timelines and deliverables may be impacted, please contact your project manager.

Additionally, we are also sending a communication to site users with information about our helpdesk and to reiterate the need to follow good hygiene principles such as regularly disinfecting devices.

Device Cleaning

Clinical Ink recommends that sites follow the infection control practices recommended by the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Utilizing appropriate personal protective equipment (PPE), including gloves and facemasks, and practicing frequent hand washing are critical to controlling the spread of COVID-19.

Clinical Ink’s logistics group follows CDC recommended guidelines for sanitizing equipment prior to shipping to sites. Additionally, all personnel use PPE when handling devices. Although we employ industrial sanitizers on all returned equipment, out of an abundance of caution, we are only deploying NEW devices as of March 2020.

Recommended Practices for SITE Usage and Cleaning Onsite Devices

  • Protective gloves should be worn while using any Clinical Ink device on-site.
  • Stylus data entry, rather than touch, should be used to enter data where possible.
  • Devices and styluses should be cleaned after each individual use before handing to another user or patient. Per CDC/WHO recommendations, this cleaning should use at least a 70% alcohol solution which is found in most disinfectant wipes in the clinical setting.
  • Devices returned by a prior patient must be thoroughly disinfected and sanitized, including removing any protective case, by rubbing all surfaces for at least 30 seconds.

Recommended Practice for PATIENT Usage and Cleaning of Mobile Devices

  • All provisioned mobile phones should be re-sanitized prior to allocating to patients.
  • Patients should routinely clean the devices throughout the day using disinfectant wipes containing a 70% alcohol solution. Additional steps for maintaining a clean/sanitary environment are found on the CDC website.

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