Business Continuity for Clinical Studies

Sustaining the delivery of services after a disruptive event, in adherence to our Human Research Protection Program (HRPP)

Clinical studies are sometimes faced with unforeseeable natural, social, or economic disasters, making it difficult for organizations to conduct their usual business activities. Such disasters may include an outbreak, severe storm, flood, fire, staff shortage, power failure, cyber-attack, security emergency, or any other damaging event, potentially resulting in:

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In order to prevent and recover from such disruptive events, it is necessary for organizations to implement business continuity measures to ensure the progression of clinical studies and other operations.

The objectives of these procedures are to:

Ensure that research activities can continue to operate, either on-site or remotely;
Minimize adverse effects to research participants, employees and collaborators;
Enable a timely and efficient return to usual business operations.

Our Business Continuity Plan

At ethica CRO, we have developed standard operating procedures (SOPs) dedicated to keeping your study ongoing in the most efficient way possible should a disruptive event face our company or your research program. We have instituted a three-step preventative measures plan (preparation, response, and recovery), which takes into consideration four degrees of disruption severity.

Preparation

Exhaustive SOPs on business continuity
Continuous employee training and engagement procedures

Response

Dedicated SOPs on conducting clinical trials during disruptive events and publicly declared emergencies

Recovery

Rigorous data security and backup procedures
Regular testing and review of the business continuity plan

Our Approach to Business Continuity

Through the implementation and application of our robust, comprehensive, accredited SOPs, we ensure that research participants’ rights and welfare are protected, our employees and collaborators are safe, and our research activities are not compromised.

How ethica CRO Manages Studies During Public Emergencies

In the last two decades alone, we have witnessed several public emergencies and natural disasters in Canada and the United States that prevented countless companies from conducting business. Currently, we are faced with a world pandemic that is affecting millions of companies worldwide, including our own.

Fortunately, ethica CRO was well prepared for the impact of COVID-19. Having thoroughly trained our staff on our accredited SOPs for business continuity and publicly declared emergencies, our team was able to rapidly and seamlessly adapt to the unruly circumstances brought upon by COVID-19. We were able to quickly modify our study management procedures in order to navigate our way through this pandemic in a successful manner.

Our secure virtual servers and collaboration tools permitted our staff to work from home immediately, following the social distancing measures put forward by our municipal, provincial, and federal governments. As ethica CRO was already used to working under these secure servers on a day-to-day basis, the transition to remote working environments was effortless for our employees.

Our biotech CRO implemented procedures and mitigation steps designed to accommodate each ongoing study based on what stage of its lifecycle the study was at when disaster hit. These safety procedures, drafted during the development of study plans and documentation, were reviewed and discussed with the sponsor and investigative sites, in order to coordinate communications with research participants, continue research activities, and secure study samples, investigational products, and research data.