Instem Provides Free SEND Services to COVID-19 Related Research & Development
20 April 2020
The U.S. Food & Drug Administration almost always requires electronic submission of non-clinical data, in an electronic format called SEND, prior to a drug or vaccine being approved for testing in humans for the first time and again before the product is released for general use.
Instem is widely acknowledged as having the world’s leading technology for creating SEND submissions. In addition, Instem has the preeminent team of over 50 SEND consultants and information scientists who undertake SEND dataset creation and submission on an outsourced services basis for many of the drugs and vaccines in the global R&D pipeline.
The Instem team has been inspired by the selfless redirection of resources and capital by the life sciences industry (among many others) to fight the COVID-19 pandemic, as well as the front-line work of doctors, nurses and others caring for today’s COVID-19 patients. We are therefore delighted to be in a position as a business and as individuals to contribute free of charge some of the world’s leading SEND related talent and technology to help rapidly advance promising new vaccines and treatments through the regulatory R&D process.
Instem is initially setting aside £100,000 of capacity to undertake free COVID-19 related SEND services. It would be fantastic to see much of this go towards supporting candidates being funded by the not-for-profit sector, such as the “COVID-19 Therapeutics Accelerator”, funded by the Bill & Melinda Gates Foundation. However, our goal is to deploy our SEND resources quickly and productively, so we will support work for ANY sponsoring organization, no matter their type or size.
We recognize that our SEND team is already heavily committed to clients for other important drug development programs and so we will limit the rate at which we undertake this additional free COVID-19 related work. We will work closely with existing clients where things need to be rescheduled to create space for this additional work and our team has committed to work outside normal hours, if necessary, to keep COVID-19 drugs on schedule (as they have already).
It is rare for us to be able to make such a unique and direct contribution to a global crisis, but it reminds us of the valuable work we do every day helping our clients bring their life changing products to market faster.
To take advantage of our free COVID-19 related services, clients can reach out to their usual Instem contact or email Free-COVID-19-Services@instem.com. We are happy to work directly with sponsors or via contract research organizations who are passing on Instem’s SEND services work to their clients without charge. To give every organization equal opportunity, this only applies to new COVID-19 related requests.
If there is more that you believe Instem can do to support your COVID-19 related R&D activities, please let us know.
We remain committed to the safety and success of our staff and clients around the world.
Read our March 24th Update