06.30.25 -- Unlocking AI's Full Potential In Clinical Trials And Regulatory Success

To adequately serve clinical monitoring without introducing new challenges, AI tools must provide seamless, high-quality data integration and operate transparently — especially to mitigate bias — and must also be designed and integrated to assuage regulatory and ethical concerns.

To streamline clinical trial data processes, sponsors, CROs, sites, and patients must avoid collecting redundant or extraneous information in the EDC system. Focusing on raw data early supports more efficient and effective interpretation later in the study.

If AI can write the first draft of a clinical study report in less than a day, why pay a medical writer? This is a scary consideration and can leave writers feeling defensive. But medical writers’ true adversary is refusal to embrace this technology and make it work for us.

Medical writing submission specialists face a range of complex challenges, from tight timelines and shifting regulatory requirements to cross-functional coordination issues. This webinar explores these obstacles and presents proven strategies to consistently set the stage for successful, high-quality submissions.

Many issues affecting regulatory submissions mirror those that derail clinical trials, such as key opinion leaders leaving a company, internal resources being reallocated, or vital equipment/system failures. Learn how these issues can be avoided by reading this article.