Guest Column | March 19, 2020

Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits

By Laurie Halloran, CEO and Chairwoman of the Board, Halloran Consulting Group, Inc.

While we have not yet seen any significant delays in regulatory approval of life science products to date, the impact of COVID-19 on global health authorities is continuing to evolve. We expect a variety of potential delays in regulatory communication and meetings that will continue for months, if not years. In this article, we will review the impact current travel restrictions and the remote working environment are having on regulatory interactions, inspections, and audits, and we will conclude with a discussion of important technology and business continuity planning considerations related to the pandemic.

1. Face-to-face interactions with the FDA that were previously scheduled for March and April of this year have been or will be converted to teleconferences.

While most in the industry appreciate the benefits of a face-to-face meeting with the FDA or any regulatory body, there are advantages to a phone conversation compared to an in-person meeting. Teleconferences allow the sponsor/applicant team (as well as the regulators) to go on mute to discuss important topics, gain team consensus, and then return to the dialogue and quickly progress the conversation. A teleconference or video conference also allows a sponsor to use chat and instant messaging capability to coordinate and focus responses for maximum effect.

2. Review cycles and timelines for meetings to be granted may be delayed.

This, of course, will depend on how much the virus impacts the health authority review teams. Should they become short-staffed due to illness or are re-assigned, we should expect delays, similar to what happened in the U.S. government shutdown in 2019.

3. Global health authorities are working in close partnership with industry and academia to quickly progress therapies, vaccines, and diagnostics for COVID-19.

While the relationship between industry and the regulators is variable, this is a time for us to partner closely with health authorities to accelerate emergency use treatments and quick startups to ensure that these potential products are of top priority. See the FDA’s statement on March 16, 2020, on the latest Diagnostic Emergency use Authorization. Several of our clients have received incredibly prompt and engaged responses from the FDA on investigational agents for COVID-19 treatment. Worldwide regulators have proven time and again that they will find ways to work with industry in the face of previous health emergencies — Ebola, Zika, SARs, H1N1, etc.

4. Expect to see delays of on-site pre-approval manufacturing site inspections.

While the FDA has announced suspensions of inspection activities in China and Europe, the extensive international travel restrictions and border closures that have been announced this week will severely limit, if not entirely halt, preapproval and many other routine facility inspections. Regulatory bodies are likely to defer any inspection that can be reasonably deferred and to employ a few virtual or correspondence-based inspections where possible. It is unclear if regulatory bodies will delay action dates or extend review periods when inspections are not possible or practical.

5. The limitations of on-site pre-approval facility inspections extend to clinical and sponsor inspections.

We expect the FDA and other regulatory agencies to rely upon several forms of virtual inspections and audits to ensure that the rights, safety, and welfare of subjects are protected, to verify the accuracy and reliability of clinical study data, and to assess study compliance with regulations. We can likely expect regulatory agencies to request sponsors to provide information electronically that would normally be evaluated during an on-site inspection. Additionally, agencies may request access to the electronic trial master file (TMF) and other systems in order to assess the conduct of the trials without an in-person visit. Interviews with subject matter experts may be conducted using either teleconferencing or video conferencing. It is important to prepare for a virtual inspection with the same rigor and structure you would for an on-site inspection. Conducting a virtual mock inspection is a great way to test your organization’s capabilities and preparedness during this time. The FDA released a statement on March 10, 2020, on COVID-19 foreign inspections, and we may see additional guidances released in the coming weeks.

6. With social distancing and travel bans, on-site GxP audits and vendor selection visits have already been impacted.

Performance of investigator sites and vendors that would normally be evaluated during an on-site audit will now need to be evaluated using alternative methods. While qualification visits and audits of vendors and sites may have to be done virtually, the requirement for maintaining documentation of sponsor oversight is as important as ever, in addition to identifying the potential risks, mitigations, and process for continuous assessment.

Impact To Technology And Mitigations

With all of the above priorities coming our way, technology may be one area that you may consider not directly impacted by COVID-19. Since many clinical and informatics platforms are now cloud-based, most business continuity plans are not prepared for a near-complete switch from in-office presence to remote users. For any plans that were prepared, they unlikely expected this mass migration to occur nearly overnight, as we are currently experiencing. As you transition to an entirely distributed (home-based) user environment, the following points are worth highlighting.

The architecture of many remote and/or virtual working environments is to facilitate some remote staff or to allow multiple company locations to communicate with ease.

It is important to ensure that the following are available to all employees or on a much larger scale than just a few weeks ago is a critical path activity:

  • hardware (laptops, monitors, and peripherals)
  • access points (licenses, seats, and VPN connections)
  • support (user guides, FAQ, and troubleshooting guides)

Video conferencing capabilities should be available for all employees, supporting continued team connection and business continuity. We are seeing an increased reliance upon interactive tools such as document sharing, instant messaging apps (like Slack), whiteboarding apps, and meeting platforms to provide employees with the more real-time interactive communication tools to aid in the remote work transition.

Network outages due directly to COVID-19 are unlikely; however, some companies are experiencing a slowdown in their networks, particularly those relying upon VPN connections to physical or virtual servers instead of cloud-based applications.

Now, more than ever, companies are thinking about moving to cloud-based systems and applications, but we know this is a longer-term investment and will not solve the immediate challenges some are facing. With some slowdowns, we have seen companies employ very intense network monitoring programs and testing procedures to try to improve connectivity issues.

With a heavy reliance upon remote access and a distributed workforce, information security practices and protocols are now being tested more than ever.

It will be surprisingly easy for staff, especially those new to remote working, to download and store sensitive information on relatively unsecure home networks and devices. Many U.S. households have Alexa-enabled networks, rely on cloud-based backup programs (such as iCloud), or have other highly connected technology. Therefore, it is very important to continue to stress information security policies and procedures for employees during this time.

Business continuity plans must be put in place (if they aren’t already) on how to operate when systems are down.

Disaster recovery plans and redundant systems should be tested to ensure they are working properly. Continuity and contingency plans may soon be tested as different countries, states, and cities enact quarantines or other restrictions on free movement of people. Those restrictions could severely impact the personnel who maintain the networks and technology platforms your business relies upon.

As noted in “8 Significant Risks COVID-19 Poses To Clinical Trials — And How To Mitigate Them,” the industry is pivoting away from on-site operational aspects of a clinical trial to a more decentralized clinical trial technology to enabling home virtual visits, telemedicine, and remote monitoring capabilities. An immediate assessment of the options available and the impact of using these tools is highly encouraged. In addition, we recommend taking a critical look at employing accelerated and abbreviated validation practices to get these tools in-use faster than may be typical, while recognizing these streamlined approaches must align to the regulations and be supported with appropriate documentation. If a third-party tool can be deployed and is already validated, that option is worth considering to further shorten deployment and ramp-up timelines. These options should be discussed with your IT department to prevent further unnecessary delays in managing clinical trial activities and ensuring critical treatments to patients who need them.

About The Author:

Laurie Halloran, BSN, MS, founded Halloran Consulting Group in 1998. Her time as a pediatric ICU nurse had inspired her to start a company that helps move new therapies through FDA processes to get them into the hands of patients desperately in need. Halloran has been named 2018 Women’s Business Enterprise Star by the Women's Business Enterprise National Council (WBENC) and has won a 2017 Enterprising Women of the Year Award from Enterprising Women magazine. Halloran Consulting Group was also named an Inc. 5000 Fastest Growing Company for the past three years in a row.