Coronavirus COVID-19:
ERT update

March 17, 2020


ERT is fully committed to supporting our customers during the current global pandemic and stopping the spread of Coronavirus (COVID-19). We remain dedicated, as always, to keeping your trial on track and ensuring the safety of all patients and investigative sites who interact with our eClinical solutions. To do so, we’ve taken the following measures since February 28, 2020:

  • Instituted a company wide travel moratorium
  • Mandated all non-essential employees to work remotely
  • Implemented a mature and robust business continuity plan
  • Formed a COVID-19 Response Team that meets daily to assess coronavirus-related developments

For customers who are on the frontlines in developing a vaccine for COVID-19, we’re offering immediate and discounted access to our vaccines eDiary platform. We’re also making it easy for patients to continue participating in clinical research with fewer site visits through our virtual trial competencies.

You can learn more about these solutions below. We look forward to working with you as the life sciences industry comes together to solve this worldwide challenge.

 

– Jim Corrigan, President and CEO, ERT

Solutions to Assist Your Research


Vaccine Trials with ERT

ERT is committed to supporting our customers as they develop a vaccine to stop the spread of Novel Coronavirus. Our dedicated vaccines eDiary solution is available immediately to those companies who are involved in the search for a vaccine.



Virtual Competencies

ERT currently offers virtual trial capabilities that allow sponsors to reduce the number of patient visits to sites and continue to run studies as normal.



FREQUENTLY ASKED QUESTIONS


How will investigator meetings be impacted by COVID-19?

The ERT Education and Training team is available to support meetings via webinar for site training. Webinar training requests can be made directly to Project Managers.

How does ERT eCOA clean devices?

ERT provisions consumer smartphones and tablets loaded with eCOA applications for use at clinical trial sites and in patients’ homes. Devices used in eCOA studies are routinely used by one person and passed on to another. All devices used during previous studies, training or testing that are returned to ERT for reuse are cleaned in accordance with the manufacturer’s instructions (e.g., spray a non-abrasive, alcohol-based (70% isopropyl) disinfectant directly on a soft, lint-free cloth or use similar anti-bacterial/anti-viral wipes — and then wipe down the device while it is powered down and unplugged; be sure to wait for a minute or two before drying the device). Once cleaned, ERT eCOA devices are stored separately prior to reuse.

If patients for a particular trial are immuno-compromised, ERT would reasonably expect that your company’s medical officer or designated representative would stipulate appropriate safeguards for any physical exchange of devices with the patient population, including ERT eCOA devices.

How does ERT clean cardiac safety devices?

ERT utilizes a variety of devices for cardiac safety data collection. We follow the respective manufacturers’ guidelines for cleaning each device to ensure devices are properly sanitized and their functionality is protected during the process.
For the cleaning of devices on site, the same manufacturer’s guidance should be followed and can be found within the manufacturer’s user manuals either on the ERT Portal, or linked to from within the ERT Study Manual.

Are there recommendations for ERT Respiratory devices?

For the following devices and accessories provided by ERT, we have carefully reviewed the guidelines for safe use in the respective ‘Instruction for Use’ (IFU) documents:

ERT Manufactured Devices

  • MasterScope CT / ECG
  • FlowScreen / FlowScreen CT
  • SpiroSphere
  • AM3 (AM3G+, AM1+, etc)
  • Clean Peak Flow Meter (CPFM)
  • ERT Pneumotachograph (ERT PT)

Third-Party Devices and Accessories (offered by ERT for use in clinical trials)

  • MicroGard II filters (manufactured by Vyaire Medical GmbH)
  • NIOX Vero (manufactured by Circassia Pharmaceuticals plc)
  • NDD EasyOne PRO (manufactured by ndd Medizintechnik AG)
  • Tremoflo (manufactured by Thorasys Thoracic Medical Systems Inc.)

For detailed recommendations regarding the safe use of these devices, please click here.

WANT TO KNOW HOW ERT CAN SUPPORT YOU?

ERT has a breadth of experience and expertise in supporting clinical research from a scientific, regulatory and commercial perspective. While this situation is unprecedented, we’re confident that we have the tools to help you stay the course during the COVID-19 crisis. To learn more about any of our solutions – including our tools for vaccine trials – click the button and fill out the form. A member of our team will be in touch shortly to find out how we can meet your needs and answer your questions.