Clinical protocols are being redefined, and ICH M11 is leading the shift. The introduction of ICH M11 and the Clinical Electronic Structured Harmonised Protocol (CeSHarP) template provides a global standard…
China’s biotech boom is transforming global drug pipelines, and in-licensing these innovative assets is opening exciting new opportunities. But here’s the challenge: great science alone doesn’t win FDA or EMA…
The global focus on obesity has never been stronger. This complex condition is now one of the fastest-growing global health challenges, impacting hundreds of millions of people and reshaping the…
Recently, Med Communications had the opportunity to introduce PharmD students at the University of Tennessee College of Pharmacy to medical writing through a one-hour guest lecture. The session kicked off…
Med Communications’ newest service area, Regulatory Writing, offers support across all stages of clinical drug development: Under the leadership of department director Ann Winter-Vann, who has more than 18 years…
Our newest department, Regulatory Writing, is led by Dr. Ann Winter-Vann. Ann received her PhD in Molecular Cancer Biology from Duke University, where she was supported by a fellowship from…
Ann Winter-Vann, director of Regulatory Writing at Med Communications, will present a workshop on Thursday, November 6 at 2 pm during the AMWA conference in Phoenix, Arizona. This sold-out workshop,…
A mid-size pharma company was amending its Phase 2 protocol when our regulatory writer noted a discrepancy in the study objectives. Addressing this issue early prevented the client from needing…
Med Communications’ team of residency-trained, industry-experienced PharmD specialists offer peer-to-peer support for healthcare professionals and providers. Our continual training cycle keeps team members up to date on the latest developments…
In drug development, a single error in data, formatting, or interpretation can delay approval, damage credibility, or even compromise patient safety. That’s why quality control (QC) review is built into…
