COVID-19 as a Catalyst for Change in Clinical Trials

Looking to the Future of Clinical Trials

Overcoming resistance to – even fear of – technology is the way for clinical trials to operate safely and efficiently, today and in the future. The usually conservative pharmaceutical industry has shown that it could flex to overcome the challenges of running clinical trials during COVID-19 – and technology was central to this adaption. Where possible, sponsors moved quickly in their adoption of solutions such as decentralized trials, wearables and real-time communication technologies.

More than ever, it is clear that clinical trials need to be digital.

The latest clinical trial information must be used to guide decisions, making it even more critical that communication is targeted to the right monitors and research staff at the right time. COVID-19 highlighted the importance of swift and accurate communication and the essential role of technology in overcoming disruption to protect patient safety and preserve data integrity. In particular, we saw challenges from the pandemic:

  • 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 need to be equipped with key information. And chances are they are fairly inexperienced with clinical trials, so they may need extra documentation.
  • Supporting “stand-in” research staff: “Trial naïve” medical and home healthcare professionals providing treatment for research patients 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 in times when situations quickly change.
  • Communicating without delay to monitors: The pandemic created incredible uncertainty. 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.

Teckro clinical trial software connects study stakeholders with the information they need, when they need it. It means continuous access to important trial instruction and guidance, even if members of the team are in self-isolation or working remotely.

With immediate access to critical study information, sites enroll the right patients faster and have fewer deviations.

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 during COVID-19 for research staff. Alternatively, Teckro can be accessed via any device through a secure web app.

Simple, Modern Clinical Trials with Teckro

Speed and accuracy of communication are everything in clinical trials. 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. Below are the key ways that Teckro supports challenges posed by COVID-19, bringing a new level of adaptability to your clinical trials.

Teckro connects research staff, study staff and monitors with the knowledge they need, when they need it.

The Technology to Provide Immediate Answers

From any digital device, answers from the current protocol and other study documents are immediately available to anyone involved in the study. Study managers have visibility into what is being searched, which can help identify the need for clarification or potential safety risks. Search activity is also a good indication of site engagement.

With the pandemic, the usual research staff may not be available to treat patients, so additional medical and home healthcare staff may need to conduct assessments and procedures. Staff who may not be routinely involved in clinical trials need immediate, accurate answers to properly manage patient care.

With Teckro you can:
  • Add new research staff from labs, local primary care sites, etc. so they have direct access to critical study information
  • Eliminate concerns about version control with only the current, approved protocol in Teckro for research staff to access
  • Coach research personnel with suggested next best actions based on their search

Proactive Compliance

Teckro alerts research staff to important study changes or updates to make sure they aren’t missed. Useful tips and clarifications can be added to Teckro and shared broadly or targeted to specific sites, monitors, or both. Study managers have visibility into who is opening their messages, so they can be sure critical updates, such as safety holds, are reaching site staff and monitors.

Regulators understand that protocol deviations are inevitable in the volatile environment of COVID-19. However, documentation and communication of these changes are vital. Monitors must be kept informed in real-time of changes and they must in turn have real-time communication with site staff.

Alternative approaches may be needed, such as methods and locations for safety assessments and delivery of investigational products. Staff must understand the procedures and data requirements, guided by current study information. All of this requires the right communication to the right people at the right time.

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 to inform monitors and site staff of critical changes or time-sensitive reminders.
  • Consolidate all of the communication in Teckro to ease reporting burdens – this can then be exported for inclusion in the TMF.
  • Centralize communication so that everyone involved can see the communication threads.

Real-Time Guidance

When in doubt, research staff may need coaching to carry out protocol instructions correctly. For this, research personnel need a way to initiate conversations directly to a dedicated group of medical, scientific and study experts as soon as the need arises. Direct guidance from the experts increases confidence in the fidelity of the information by site staff and also reduces the time delays with back and forth with intermediaries. 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.

With Teckro you can:
  • Ensure that no query goes unanswered and that communication threads are managed through to resolution
  • Give newer or inexperienced staff members a direct line to confirm what is required to correctly carry out procedures or visit schedules
  • Gain valuable insight and take proactive action by learning from site questions and issues

Adapting Clinical Trial Operations in Response to COVID-19

COVID-19 has shone a spotlight on clinical trials for the general public. Clinical trial terminology entered the mainstream as people watched the collaborations between pharmaceutical companies and governments in the race to develop and test a vaccine. The importance of clinical trials continues to have a prominent place in daily media.

With a greater awareness of clinical trials among the general public, there is momentum that could lead to greater participation by volunteers and physicians alike. However, to make clinical trials more accessible and transparent, it is necessary to address the vulnerabilities of today’s clinical trial operations made very visible by COVID-19.

We can’t go back to the “old way” of doing things.

With the pandemic as a catalyst for change, now is the time to modernize and simplify clinical trials. 

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