Dear Valued Customers and Partners
As a clinical research organisation operating globally, the Bionical Emas Group takes human health extremely seriously. As the COVID-19 situation continues to develop, we remain committed to our core objective of bringing new medicines to patients who need them around the world. This statement outlines the approach we are taking in relation to the current COVID-19/coronavirus situation.
Our priority is to protect the health, safety and well-being of our employees and their families, our customers and the patients we serve. We are committed to doing what we can to restrict the spread of this virus, whilst maintaining our services to our customers and patients wherever reasonably possible. In meeting these challenges, please be assured that we will never put quality at risk.
The COVID-19 situation is developing rapidly. To best respond to the challenge this presents, we are taking a structured, consistent approach, whilst keeping decision-making agile to react quickly and appropriately to constant change. We have in place a COVID-19 Steering Group which includes our CEO, our Chief Medical Officer, our Group Legal Director and our Divisional Directors, which reviews the situation on a regular basis and decides upon and effects appropriate responses to the COVID-19 challenge. On a daily basis, our Quality group monitors all applicable governmental and other official agency guidances. Material changes in guidance are reported to our Steering Group immediately, so we can reflect those changes in our activities equally quickly.
Bionical Emas is making every effort to reduce the impact of COVID-19 on the services we deliver to our customers and the patients we serve. In order to do so, we are taking precautions to protect our employees, which in turn helps to ensure business continuity. We continue to follow guidance from the World Health Organisation (WHO), US Centre for Disease Control (CDC), UK Government and other local health authorities.
In line with the most recent updates released by these authorities, Bionical Emas has taken the following precautionary measures:
- All office-based employees who can work from home to do so with immediate effect;
- Those who cannot work from home due to the nature of their roles (e.g. distribution centre staff) are being placed on a rotating schedule to ensure business continuity if an individual becomes unwell in one team;
- Additional deep cleaning taking place in all office and warehouse locations;
- Additional IT infrastructure and support put in place to ensure connectivity and communication channels remain in place with colleagues, customers, healthcare professionals and patients;
- Appropriate guidance and instructions given to our staff, wherever they are working. This includes hygiene advice, guidance on appropriate precautions to take, and instructions on travel.
All travel which is not essential, both international and domestic, has been prohibited.
With evolving travel restrictions, we are continuing to follow government guidance on travel. Wherever possible we are utilising virtual technologies to hold meetings and will continue to work closely with our customers and partners to adopt the best ways to communicate and collaborate during these challenging times. We remain agile to adapt to new technologies and our specialist IT team is on hand to ensure we have the capability to adopt new systems quickly, whilst maintaining alignment with regulations and customer needs and procedures.
Currently, many investigator sites are (understandably) restricting access to CRAs. Our global Clinical Development team has adapted quickly to these changes. In agreement with our clients and study sites, alternative monitoring strategies and technologies have been implemented. To ensure that we continue to deliver our services wherever we reasonably can, we have instigated detailed risk management planning across all services. Where our clients require additional support at this difficult time, we have the full capability to respond, and will do so where we reasonably can without undue risk to health.
Early Access Programs (EAP)
Our EAPs are currently supplying medicines to patients around the world who are in desperate need. Continuity of supply for these patients, as is always the case, remains the overriding priority for our EAP division. At present, all of our supply routes are running effectively to ensure this and we continue to work to protect these channels. We are working closely with all our clients to ensure that whilst we mitigate the risks of COVID-19, we are also doing everything we can to ensure that patients with other conditions receive timely access to the critical medicines they need.
Clinical Trial Supply (CTS)
Our UK and US distribution centres continue to remain open. We are adopting a rotating staff model to ensure we reduce the number of staff requiring self-isolation should an individual become unwell or test positive for COVID-19.
We continue to monitor the situation in respect of transport of product to and from affected countries/areas and follow all applicable government guidance in respect of such. We are working with our logistics partners to ensure that all routes are mapped out prior to any movement of product. Where it is reasonable and feasible for us to do so, and our customer wishes us to do so, we will seek alternative product supply routes. Additionally, we are conducting a weekly risk assessment on supply routes and products being procured for our customers’ on-going clinical trials. Your dedicated account manager will alert you of any potential risks involved in the continuity of your supply. Furthermore, if an upcoming risk is identified, we can seek to bring orders forward to ensure supply continuity through this period of uncertainty.
On behalf of us all at Bionical Emas, we would like to share our heartfelt empathy with all those affected by the global COVID-19 pandemic. We promise to remain agile and supportive in adapting to this unprecedented challenge, to ensure we continue to deliver our services wherever possible, and to bring valuable new medicines to patients who need them around the world.
If you have any queries about this statement or Bionical Emas’s activities in relation to the COVID19 situation, please contact your usual Bionical Emas contact or email firstname.lastname@example.org.