December 3, 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, EMA, MHRA, and WCG IRB guidance.

Supply Chain Impact

The increasing impact of COVID-19 is causing local, state, and national governments around the world to issue expanded work and travel restrictions, which, coupled with the holiday season, is causing more disruption to the global supply chain. Due to these restrictions Clinical Ink is beginning to see shipping delays with our supply chain and shipping vendors that are impacting our customers.

We are working diligently with the supply chain and shipping vendors to avoid any delays. Our collective goal is to deliver the equipment as quickly and efficiently as possible.

We will do our best to provide the most accurate estimates of delivery times for when you can expect to receive your shipment. Because the shipping carriers are expecting shipping delays and are unable to guarantee when your shipment will arrive, we recommend you request the devices at least 4 weeks (US) and 6 weeks (ROW) to account for these delays. Should we encounter any unexpected shipping delays or unforeseen inventory challenges, we will notify you via email.

Study Assurance Program: Waiving Change Orders to Keep Your Trial Running

By interrupting new patient enrollment and discouraging existing patients from participating, COVID-19 is disrupting clinical trials. Our Study Assurance Program offers new and existing clients contract adjustments worth millions of dollars. You can avoid cost increases for all current and new studies, with benefits such as:

  1. Change-order waiver of all platform licensing and help desk fees for a period of up to 3 months
  2. Waiver of project management fees for implementing BYOD (bring your own device) ePRO deployment (e.g., IRB approvals, scale license provisioning, device management plans)
  3. No charge for help desk services to directly assist patients in mastering “virtual visit” technologies for the duration of your study
  4. Expanded logistics options that now include directly provisioning phones, tablets, and internet connectivity to patients in need

We are also changing how we approach service delivery. For example, we recently deployed a new direct data capture (DDC) study for a novel COVID-19 treatment option in just 15 days!

To learn more about this program and about Clinical Ink’s virtual trial offerings in general, including DDC, eCOA, ePRO, eConsent, and other capabilities, please read the PR on our Study Assurance Program and download our virtual trial fact sheet.

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.

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. Clinical Ink is prepared to offer a rapid BYOD build timeline to address current demand.
  • 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.

Web-Conferencing Platforms

Clinical Ink’s Lunexis platform seamlessly supports documentation of virtual visits. Rather than building a ‘custom video tool’, our approach is to encourage research sites to utilize whichever video interaction platform they are most familiar with (e.g. Zoom, WebEx, GoToMeeting, Teams, etc). Critically, each of these platforms has features specifically intended to comply with various international regulations related to patient privacy and data security. Sites are responsible to enable these features and to use these platforms in accordance with appropriate site SOPs, patient standard of care recommendations, Good Clinical Practice Guidelines, and recent regulatory guidance around the use of virtual platforms to deal with COVID-19 related disruptions.

We’re Donating Devices So Behavioral-Health Clients Can Stay Connected

To help our community in this time of need, Clinical Ink is providing hundreds of mobile devices and tablets to Baltimore-Washington area Thrive Behavioral Health. This contribution will support crucial tele-mental health services for individuals and their families.

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