Since the emergence of the COVID-19 global pandemic, Apex Innovative Sciences (Apex) has distinguished itself as a leader in clinical trial continuity strategies.  On the heels of FDA and CDC guidance in March 2020, Apex immediately instituted its COVID-19 Risk Mitigation and Response Plan.  This leadership has led to the continuity of its clients' trials and the "rescue" of clinical trials for other pharma clients.

"The ultimate goal is to maintain the highest level of safety for the patients enrolled in our trials as well as safety for all the essential workers supporting these vital clinical studies," said Dr. Howard Hassman, Chief Executive Officer, Apex.  "We are committed to exercising prudence and adhering to a standard of care that protects our research subjects, our employees, and the entire study team." 

"We've been at the forefront of trial continuity during COVID-19 from the very beginning of the pandemic," said David P. Walling, Ph.D., Chief Clinical Officer, Apex.  "We positioned Apex by looking at the scientific data and making sure that we can safely continue trials while protecting the health of our subjects, the needs of our sponsors, and the safety of our employees." 

Since March 2020, Apex participated in the International Society for CNS Clinical Trials and Methodology (ISCTM) Innovative Technologies Working Group. This working group made a significant impact developing guidelines to ensure clinical trial continuity during the pandemic. Similarly, Apex was a significant partner on the CNS Summit COVID-19 Response Task Force.  This CNS Summit Working Group of more than 200 clinical research and site management professionals convened virtual meetings  to ensure trial continuity during COVID. 

As a leader in Central Nervous System (CNS) clinical trials, Apex has remained steadfastly committed to ensuring that these trials continue on schedule during the pandemic.  "It is hard enough for patients and caregivers dealing with CNS issues, such as depression, anxiety, and addiction, without adding the possible risk of their trial being shut down or delayed due to the COVID-19 pandemic," said Shawna Cote, Chief Compliance Officer, Apex. "For many of our studies, we provide the only clinical care our study volunteers receive; frequently, many have no insurance coverage and cannot afford out of pocket expenses for care."

Besides keeping current trials on track during the COVID-19 pandemic, Apex has been awarded contracts to "rescue" trials that other sites could not move forward.  "Our partners at Apex were the earliest to recognize and prepare for COVID-19.  Ensuring that patients, physicians, and employees were safe and protected was a primary concern – but more important that clinical trials be continued despite the pandemic," said Dr. Tom Hochadel, CEO, Cognitive Research Corporation.  "We asked Apex if they could safely continue two pivotal phase 3 efficacy trials we were engaged with them on in schizophrenia and bipolar disorder.  With strong COVID policies in place, Apex stepped up not only to ensure that the trials continued, but to ensure the trials were there to help provide healthcare to patients in this challenging population."  In the end, both of these trials were completed successfully and on time, added Dr. Hochadel.

In addition to Apex's long-standing leadership in CNS research, the company is expanding into new research areas, including Human Abuse Liability, Addiction, Asian Bridging, Psychedelics, and Driving Simulation. In line with Apex's expansion, combined with its blueprint for trial continuity during COVID, Apex has also been awarded contracts to manage COVID-19 vaccine trials.

"We recently began supporting the enrollment and management of several of the vaccine trials that are currently in the news, including trials for Astra Zeneca, Pfizer, and Janssen," said Dr. Hassman.

About Apex Innovative Sciences

Apex Innovative Sciences is a global provider of clinical development and site services. Apex represents the consolidation of core businesses including Hassman Research Institute, CNS Network and Clinical Trial Centers Alliance.  The expanded team collaborates to provide quality, efficiency, and value in the development of innovative medicines. Apex helps sponsors achieve go/no-go decisions, reduce development costs, and deliver high quality results.  Apex is committed to providing scientific, technological, and organizational expertise in phase I - IV clinical trials, including neurology, psychiatry, addiction, Asian bridging, pain, healthy subjects and general medicine. The company prides itself on delivering the highest scientific and clinical quality for its client partners and participants.