by Avery Zimmerman | Feb 28, 2019 | Blog
Rare diseases are often overlooked, but they affect many individuals. There may be as many as 7,000 rare diseases affecting approximately 25-30 million people in the US alone, according to the National Institutes of Health (NIH). Rare diseases are defined as...
by Avery Zimmerman | Jan 31, 2019 | Uncategorized
Tips for Nonclinical Pharmacology and the Medical Writers that Draft Regulatory Submissions by September Mihaly, Ph.D., RAC Summarizing nonclinical studies in Module 2.6 of the common technical document (CTD) takes a unique skillset. These studies include...
by Avery Zimmerman | Aug 16, 2018 | Blog
“The quickest way to negatively impact timelines is to have quality issues that require rework,” said Regina Parott, Senior Manager, Medical Writing & Transparency, MMS. This was a key point brought back by Parott from a recent sponsor quality forum where it was...
by curtis@digitalliance.com | Jun 21, 2018 | Blog
Many Ph.D. graduate students are led to believe that there are only two routes to take after graduation: Research projects in academia or industry. On the contrary, one thing that many do not see is that they have obtained a set of unique, invaluable skills that can...
by curtis@digitalliance.com | May 31, 2018 | Blog
The size of the global pharmaceutical market will reach $1.12 trillion by the year 2022, according to Pharmaceutical Commerce. Yet, many questions linger about what the future of drug development will look like, including technology that will impact the industry and...