Regulatory Medical Writing
How we help with Regulatory Medical Writing
For some organizations, it is not possible to sponsor a full-time medical writer, and everyone knows how important it is to convey the research, methodology, and findings clearly and concisely. Halloran provides medical writing expertise to meet four specific needs:
- Investigator Brochure: Using content from the relevant sections of the IND and protocol and working in conjunction with your organization’s medical and scientific experts, we will create the necessary documentation and a quality check which includes verification of the finer details.
- Informed Consent Forms: We will review the principles and requirements of informed consent, share common challenges and recommendations in the landscape of increasingly complex clinical studies, and unpack the FDA’s final guidance on your informed consent forms.
- Protocols and Protocol Synopses: We can craft detailed protocols and protocol amendments that serve as the blueprint for your clinical trials and research studies.
- Systematic Literature Reviews: We conduct systematic literature reviews are a specific type of review that utilizes a set of defined and reproducible ‘rules’ developed before undertaking the review to ensure a rigorous methodology and to minimize bias.
We can transform scientific data and research findings into compelling stories to accurately your story in improving human health.
Oncology drug development is different from most drug development programs in other therapeutic areas, or at least, has been historically. While most drugs are evaluated in randomized dose-ranging trials prior to pursuing pivotal clinical studies, oncology drug development, by comparison, is often accelerated due to the life-threatening nature of most cancers and the inherent toxicity […]
Shawn Roach, one of Halloran’s Regulatory Chemistry, Manufacturing, and Controls (CMC) experts, was a panelist at the Advancing Drug Development Forum (ADDF) held in Boston on December 14, 2023. Shawn and his fellow panelists discussed the regulatory implications of the FDA Modernization Act 2.0. Passed about a year ago, the FDA Modernization Act 2.0 formally overturned […]
On September 29, 2023, the U.S. Food and Drug Administration (FDA) announced their proposed rule, “Medical Devices; Laboratory Developed Tests.” The rule, if finalized, would amend the Federal Food, Drug, and Cosmetic Act (FD&C Act) such that laboratory developed tests (LDTs) would be regulated as medical devices. The FDA is proposing a policy under which […]