To our valued customers and colleagues:
In the wake of the COVID-10 crisis, we have listened to understand the impact that COVID-19 is having on the BioPharma, Medical Device and CRO industries, and beyond. We share our deepest sympathy for the individuals and communities who are being affected by the global health crisis. Catalyst continues to closely monitor the situation, and our ultimate position remains to support the vital work being done in clinical research so that life-changing therapies can continue to be delivered into the hands of the patients that need them.
We have devised a plan to take precautions around not only the health and safety of our staff and their families, but also our communities, customers and patients. Catalyst is following the CDC’s recommendations at this time, and all staff are working remotely and are available during regular business hours. Though corporate travel and face-to-face meetings have been limited or canceled, scheduled meetings will continue to occur when possible through telecommunications.
We are ready to implement devised strategies for our customers which will ensure the continued successful execution of studies within the current landscape. With safety and security measures in place to support our staff, we are ready to help you finish what you started.
Earlier this month, we sent out a message recognizing that CRA travel was an impediment to timely and effective monitoring, and that Catalyst could support you with regional CRAs local to sites. Though this message still applies, in some situations, the environment has changed, and sites are not allowing monitoring visits at their facilities. In these cases, we’re ready to devise a study-specific contingency plan to support remote study management and/or to help get you back on track with the bolus of work forthcoming as sites reopen.
Recognizing that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, the FDA has issued guidance for industry, investigators, and IRBs. The guidance is intended to provide general considerations to assist in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic. To read the guidance in full, please see the FDA website.
We are making every effort to minimize the impact of COVID-19 for you and your study while keeping the safety of our staff and improving the lives of patients worldwide as our top priorities. When the time is right, we’re here to assist in any measure.
Sincerely,
Nick Dyer
Chief Executive Officer
