Solution Overviews

Supporting Clinical Trial Continuity during COVID-19 Pandemic

Given the global scale of disruption from COVID-19, sponsors are faced with difficult decisions whether to continue ongoing clinical trials.

Due to the pandemic, many clinical trials are undergoing critical protocol modifications and have put enrollment on hold. Some sponsors have even opted to suspend their trials.

The FDA published updated recommendations on May 14 that offer additional guidance for ongoing clinical trials during the COVID-19 crisis. Similar updates were recently published by the European Medicines Agency (EMA) in conjunction with working groups from the European Commission and the national Heads of Medicines Agency (HMA).

Continuity of Clinical Trials with COVID-19 Disruptions

Challenges for Ongoing Clinical Trials

For ongoing clinical trials, sponsors are executing risk-based contingency plans to protect patient safety and preserve data integrity. Still, there are a number of challenges posed by COVID-19:

  • Disruptions may require changes in methods for safety assessments, delivery of investigational products, or locations, such as local labs to take safety bloods or scans.
  • There is a good chance that usual research staff, particularly sub-investigators and nurses may not be available to treat research patients. The staff that is available to provide care may not previously have been involved in clinical trials and may require extra support.
  • Clinical trial monitoring requires communication at a new level of speed and urgency. Monitors must be kept informed of changes in real time. And they must in turn have real-time communication with site staff.   

Supporting Continuity of Clinical Trials with Teckro

Teckro connects research staff and monitors with critical study information when they need it. From any digital device, answers from the protocol and other study documents are immediately available. It also means continuous access to important trial documents and information, even if members of the team are in self-isolation or working remotely.

Directed communication can alert monitors and site staff of specific study changes relevant to them. Unlike other impromptu communication channels, Teckro is compliant with industry regulations, including 21 CFR Part 11. Communication is centralized in Teckro and afterwards, your regulatory team can export for inclusion in your TMF. 

Here is how Teckro can help with the specific challenges related to COVID-19 disruptions:

Adapting clinical trial operations: Finding alternatives for safety assessments and product delivery requires extra preparation, coordination and communication. Pharmacies, local doctors, or phlebotomy outreach stations will need to be equipped with key information. And chances are they are fairly inexperienced with clinical trials, so they may need extra documentation.

With Teckro you can:

  • Easily update the people on an existing trial so that staff from labs, local primary care sites, etc. have direct access to critical study information
  • Centralize communication with third parties so that everyone involved can see the threads
  • Push alerts so that everyone is informed in real time of any critical updates or changes

Supporting “stand-in” research staff: In the case of other “trial naïve” medical and home healthcare professionals providing treatment for research patients, they need immediate and current information on hand when they are with the patient. And they must have the latest study information, which can be challenging as situations quickly change.

With Teckro you can:

  • Quickly include new research staff members so they have all critical study information when they need it
  • Provide specific guidance for newer or perhaps more inexperienced staff members to ensure procedures are correctly carried out
  • Send alerts in advance of the patient visit to reiterate exact procedures

Communicating without delay to monitors: This is an incredibly uncertain time. In this kind of environment, there can be no delay in communication. Decisions that impact patient safety must be urgently communicated. At the same time, different sites, different roles, and different countries shouldn’t necessarily receive the exact same guidance.

With Teckro you can:

  • Target messages to specific sites and monitors so that they are getting relevant, critical study-specific updates for their current situation
  • Push alerts and notifications to get the attention of monitors and site staff that there are critical changes they need to know
  • Consolidate all of the communication in Teckro to ease reporting burdens – this can then be exported for inclusion in the TMF

Quick Time to Benefit

Teckro is cloud-based software, which means there is nothing to install. Users have the choice to access Teckro with a dedicated mobile app, which is particularly useful given the situation of unexpected self-isolation for research staff.  Alternatively, Teckro can be accessed via any device through a secure website.

We know speed and accuracy of communication is everything. The flexibility of Teckro means we can quickly adapt for urgent COVID-19 support so that critical study updates are easy for staff and monitors to consume.

If you are already using Teckro, we can adapt your current studies to include additional documents/users and, if needed, quickly deploy Teckro on your other high-risk studies. If you aren’t currently using Teckro, our team of experts can provide guidance on how to best set up Teckro quickly to support your clinical trials.