The medical writers at Jenniss Research take ownership of the document development process from start to finish. Our writing expertise, project management skills, and flexible approach allow us to work independently or collaboratively with sponsors on a wide range of projects from study protocols and reports to entire marketing applications. We prepare detailed outlines, write complete document drafts, lead review meetings, and finalize documents. In addition, our project management team creates timelines that lead to successful completion of key milestones.
As medical writers and editors, we generate clear and precise documents. As project managers we focus on organization, task execution, and meeting project timelines. Our area of expertise comprises document development in three overlapping document areas:
- Clinical
- Regulatory
- Scientific
Clinical Documents
Jenniss Research medical writers have an in-depth knowledge of clinical research framework. As a consequence, we generate documents that meet the needs of several audiences, including sponsors, investigators, IRBs, medical monitors, biostatisticians, and regulatory reviewers. We develop:
- Clinical study protocols and amendments, Phase 1-4
- ICH E3 clinical study reports (CSRs), Phase 1-4
- Safety narratives
- Investigator’s Brochures
- Interim analysis reports
- Informed consent forms
- Clinicaltrials.gov information upload and maintenance
Regulatory Documents
The medical writers at Jenniss Research have extensive experience in developing submissions that comply with regulations, incorporate overall presentation strategies, and render clear and concise presentations of complex scientific information for agency reviewers. Regulatory writing projects include
- IND and NDA submissions
- Clinical summaries and overviews (Modules 2.5 and 2.7 of eCTD)
- Nonclinical summaries, overviews, and tabulations (Sections 2.4 and 2.6 of eCTD)
- Integrated summaries of efficacy (ISE)
- Integrated summaries of safety (ISS)
- IND annual reports
- Development safety update reports (DSUR)
- Regulatory meeting briefing packages
- Literature reviews
Scientific Documents
The Jenniss Research writing team understands that communicating the results of scientific research is essential in the pharmaceutical and medical device industries. Our staff have written, edited, and produced a variety of communications, including the following:
- White papers
- Literature summaries
- Peer-reviewed manuscripts
- Poster presentations
- Patient care guidelines