I have had the pleasure of working with Kate on a multitude of products over the last 10 years. In fact, Kate is my “go to” medical writer for all my clients. There are several reasons for this: Kate is a well-trained scientist who understands the subject matter, both translational as well as clinical, and is able to help put documents together that have clarity. Additionally, she understands the strategy and major issues that need to be addressed, and often raises relevant questions to make sure that nothing is missed. All of this is combined with an exceptional ability to work with people. In all the years we have worked together the teams come to consider her an essential member of the team and trust her judgement. Kate has a wonderful, knowledgeable partner, Kristin, who is also experienced and wonderful to work with. They are supported by several other writers and everyone on their team has to meet SRSC’s high standards. - Bonnie Goldmann, MD
I have recently had the opportunity of working with Kate and her team at SRSC on both an Orphan Drug Designation application and a pre-IND meeting briefing document – and it was sincerely one of the most positive and streamlined agency submissions I’ve experienced! Kate is an extremely qualified and highly skilled medical writer, but what set the experience apart was her strategic and critical thinking as well – she provided expert input throughout the process all the while rendering a complicated document easily readable and imminently fit for purpose. She worked quickly on our behalf as our timelines were further and further compressed and was extremely reliable in ensuring all deliverables were met – with unparalleled quality. We all not only appreciated the fact that Kate and her team provided comprehensive documents that were consistent, clear, concise, and free of errors, but came to rely heavily on her as we finalized our documents. She was available, flexible and became a true partner in the process. Highly recommend working with Kate and her team! - Jessica St. Peter, Head of Clinical Operations
I have had the privilege of working with SRSC since 2014. Kate, Kristin, and their team are not only a pleasure to work with, but they also reliably and consistently provide project work and strategy insight that is scientifically sound, well thought out, and of the highest quality (making my job as a head of regulatory much easier!). I highly recommend SRSC for their expertise with understanding and synthesizing large amounts of clinical data and translating it into relevant and impactful messages. Having a background in medical writing myself, my standards are very high, and they meet or exceed my expectations each and every time. - Alicia Fiscus, MS, CCRP, RAC Head of Global Regulatory Affairs & GCP/GLP Quality Assurance,
I've had the pleasure of working with Kate and Kristin (fondly known as double K) since I joined the biotech industry over 20 years ago. These talented medical writers can take scientific ideas and clinical data and create clear, easily readable and logical clin/reg documents of the highest quality including pre-IND briefing books, INDs, protocols, breakthrough and prime documents, orphan designation documents and importantly NDAs, BLAs and MAAs. Their first drafts are typically so strong that the time to their finalization is limited. Not only is their writing strong, but their organizational skills and attention to detail shine through while working within the team. Kate and Kristin know each other's strengths such that they are able to apportion responsibilities yet work together seamlessly. There are many things that set double K apart from other writers with whom I've worked. Two that stand out are their ability to articulate challenging concepts and highlight key clinical data using tables and figures when appropriate and their highly efficient process to create documents. Finally, I've gotten consistently high-level feedback from clients to whom I've referred KK. - Jim Streisand, MD, Principal