We were ready for COVID-19

I’ve been hesitant to partake in this type of publication for a few reasons. First, it’s been done so many times. Multiple clinical research related companies have publicly commented about their response to COVID-19. The sharing of response methods certainly provides assurances about business continuity during a global pandemic. However, seeing the sheer volume of similar publications prompts the following internal monologue “We were prepared. Surely we weren’t the only ones?” The latter, i.e. the second guessing, being my second point of hesitation.

“It’s best to have your tools with you. If you don’t, you’re apt to find something you didn’t expect and get discouraged.” ― Stephen King, On Writing: A Memoir of the Craft

How were we ready?

My colleagues and I have worked in complex oncology, rare/orphan diseases and technology development for most of our careers.

RELEVANT EXPERIENCE

• 1,500 Clinical Studies and counting
• Experienced in Phases I-IV (specialized teams)
• Global locations and team
• Oncology and rare/orphan disease focused

Some examples include:

• Remote SDV/SDR/query resolution, we’ve been working with sites in a remote construct for years ranging from remote EMR/EHR access to the good old days of telephone and fax queries.
• The trials we run are generally very long and our patients can be very sick. Patients move, go on vacation, or just can’t make it to the office meaning for about a decade we’ve been designing trials with visit windows and accommodations for telehealth visits or assessments completed outside of the Principal Investigator’s site.
• Sites need a method to provide source. We have established secure portals already in rotation. encapsia has existing multimedia upload functionality within its eSource app. In response to the pandemic, we simply turned on the multimedia upload functionality for EDC giving sites another easy and secure method to share source.
• We have existing eConsent or eCOA relationships and state of the art integration functionality in our encapsia platform.
• Site Selection and Initiation Visits? The requirements are based on verification. Thanks to technology and the advances our IT team had already deployed in our tech suite, we had multiple methods of secure and compliant verification.
• Our QA team has been conducting and hosting remote audits since 2007.

I doubt anyone in the industry could have been completely prepared for COVID-19. At Aixial Group, we deployed some immediate response measures like providing our holistic platform not for profit for COVID-19 trials and our ongoing business continuity planning needed to pivot, but our experience and prior preparation allowed us to finish that quickly.

Our team continues to stay vigilant. It’s an ongoing process of seeking new information plus staying current with trends and cutting-edge developments to ensure Aixial Group is where technology meets expertise. Moving through COVID-19 is a tremendous project-based learning opportunity for our team’s development. I hope they put this experience in their toolkit and reference it later in their career.

Aixial Group is a full service, global CRO. Our team is a carefully curated assembly of multi-disciplined individuals. We have been approaching trials from a point of efficiency and technological solutions for over twenty years. If you would like to talk to our team about your upcoming study or an ongoing trial needing assistance, please contact us at info@aixial.com