Latest Developments and Insights

Nancy Smith Senior Vice President, Medical Writing Services After I completed my PhD (in biomedicine with a focus on immunology), I was solidly entrenched in academia as a post-doctoral scientist at the Duke Human Vaccine Institute. While the rapidly evolving…

February 29, 2024 | Evan DuBose, PhD and Kelsey Gray, PhD – Clinical Research Scientists | Medical Writing Services   Does scheduling meetings feel like a circus act between juggling multiple calendars and balancing competing priorities? If so, you will…

February 16, 2024 | Yash Patel, PharmD, Yamini Purohit, PhD, and Kelsey Gray, PhD – Medical Writing Fellows | Medical Writing Services   Regulatory medical writers play a key role in facilitating the development and compilation of documents that are…

Selecting a Contract Development and Marketing Organization (CDMO) is not a new topic, and much has been written and learned since CDMO’s first started to become an option in the late 1990s. If the decision is to outsource, selecting a…

  Our team of medical writers has worked with many clients on marketing applications (e.g., NDA, ANDA, BLA, or MAA) across a variety of therapeutic areas. Each submission is a challenge in its own unique way, but we have found…

  Whether it’s a clinical study report (CSR) for a single clinical study or a Clinical Overview that summarizes a complex clinical development program, it’s often best to consider who you’re writing for at the very start of a writing…