Study Monitoring During A Pandemic – What You Need To Know About Virtual And On-Site Monitoring Of Nonclinical Studies

COVID-19 has had an unmeasurable toll on us both personally and professionally.  It has affected every aspect of our lives, including the monitoring of nonclinical studies.  Arguably, monitoring has been impacted more than most other aspects of drug development.  While restrictions have loosened during the pandemic, working in tightly regulated environments such as nonclinical CROs continues to be challenging.

Those of us working in this area know that study monitoring is vital to ensuring a smooth path through the nonclinical portion of the drug development process by limiting unexpected hurdles.

The financial costs associated with running IND/NDA enabling nonclinical studies is significant; and assuring that studies are performed efficiently and accurately from a scientific and regulatory perspective can avoid any setbacks to the drug development path.

How does a thoughtful Sponsor accomplish monitoring during a pandemic?  Like everything else in our professional lives, virtually.  Intrinsik has conducted virtual monitoring and GLP audits for many nonclinical studies over the past year.  Virtual monitoring is generally impersonal, and while it is no easy task, it can work and be extremely productive.

Here are a couple of key tips and tricks to nonclinical study virtual monitoring that Intrinsik has identified:

• A thorough understanding of what can be viewed virtually is crucial. This may include documents, raw data, SOPs, training records, or viewing procedures such as dosing or pharmacy preparations.
• A well-tailored and efficient plan based on what is truly essential to be monitored in your study, and what is available to you virtually from the CRO.
• Key expectations from a monitoring perspective must be established with the Study Director, QA, and management, letting them know exactly what and why you are monitoring. Mid-visit pivoting is difficult during virtual monitoring, and as such, it is essential to stay focused.
• Clear and efficient communication is critical. If issues arise, information must be shared in a straightforward and rapid manner.  CROs constantly struggle with busy schedules and staffing issues; therefore, providing clear and timely feedback will ensure that issues can be immediately addressed so as to minimize potential impact on the study.

In addition to the tips listed above, you also need to keep in mind that as a monitor it is your responsibility to demonstrate Sponsor involvement/oversight of the program.  You must develop a close relationship with the staff responsible for the study at the CRO, which is not always easy behind a computer screen.

Relaxing Restrictions – So What Now?

In addition to virtual monitoring, other options are available as restrictions have been eased in certain circumstances.  One example that we have seen is that the CROs in Montreal are allowing local monitors on-site.  You may believe that this alleviates some of the issues with virtual monitoring, but not so fast – while they have opened their doors a little, it is certainly not the way it was pre-pandemic.  As such, Intrinsik knows it is crucial to have a seasoned professional who understands the internal processes of CROs and adds a level of experience to the process.  CROs are very busy and limited with monitoring resources, so they expect a productive and organized visit.

Here is how to approach on-site monitoring during COVID-19:

• Usual extensive upfront preparation and virtual discussion with the Study Director to understand what is allowed under COVID restrictions and which aspects of the study on-site monitoring can be permitted.
• Use established virtual data portals and other tools to do as much as possible while at home.
• Do not expect lots of socialization time; while all monitors like on-site lunch and snacks, it is not realistic during COVID.
• Review and prioritize the regulatory driving documents (Study Plans/Protocols) to assess which critical activities to monitor.
• While on-site, focus on key requirements for your study. Are the animals in good health?  Are the pharmacy staff and technical staff well-trained, experienced, and following proper procedures?  These points seem obvious; however, can be overlooked with limited time.
• Make an impact when you are on-site; make observations of procedures in real time and remember that corrections or alterations can be implemented almost immediately. Any issues need to be handled in real time.

Other Points of Consideration

Try your best to assure that the CRO has all the information needed, especially with respect to test article handling and pharmacy preparation.  The transportation of test samples for both laboratory and pathology assessment have been majorly impacted with COVID, so be very thorough in checking into all of it.

Expect the unexpected.  We have all experienced cases where dose formulations do not always work as planned during scale-up or animals have presented with unexpected clinical observations (i.e., convulsions, anaphylaxis, or CNS).  Having someone on-site to guide the CRO is very valuable, so ensure your monitor is comfortable with answering questions.

Be patient and professionally understanding.  Communication is not going to be perfect; and yes, issues may arise, but now more than ever, working together to resolve them is essential.

How Can Intrinsik Help?

Intrinsik has a Study Site Monitor who is based in Quebec, and able to be on-site when required to oversee and represent Sponsors during critical phases of the study, and who has formed well-established relationships with laboratories in the region.  With over 35 years of experience, Intrinsik’s expert team of scientists can help with all aspects of your monitoring needs.

For more information on how Intrinsik can help your company, please contact .

Intrinsik Bloggers:

Mike Luksic, Vice President and Senior Toxicologist
Robert Tavcar, Senior Director, Nonclinical Study Management