Integrated Regulatory & Safety Reporting
“The difference between the right word and almost the right word is the difference between lightning and the lightning bug.” — Mark Twain
Although Mark Twain probably never heard the terms aggregate reporting or line listing; confronted a Periodic Safety Update Report, a Press Release, or an integrated safety summary; or wrestled with issues related to an annual Investigational New Drug report, we can’t argue with his insight; precision in language is essential to clear communication.
Regardless of your specific reporting need, our responsibility is to be certain that our use of language is correctly aligned with your expectations, the data itself, and, of course, global regulatory requirements and guidelines. As experts with significant regulatory experience, we understand the sensitivity reporting documents require, as well as the underlying implication accompanying all forms of regulatory reporting — once a report is documented and official, it endures.
For that reason alone, we’re meticulous in our approach to regulatory writing, blending experienced talent with established standard operating procedures and proven templates. We gather the best data sets, assemble a highly-skilled team of professional writers, and provide the resources needed to ensure we never miss a deadline. Our strategy when drafting text is to continually check for style compatibility, ensuring our presentations of Adverse Drug Reaction (ADR) Summary Tabulations and other critical tables, charts, and visual elements are clear, accurate, and powerful.
Especially in regulatory reporting, words matter. To make sure you get the right ones, talk to Sentrx.
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Regulatory Writing At A Glance
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- Individual Case Safety Report
- Aggregate Reporting
- Epidemiology Reports and Signaling Reports
- Defense Medical Standardization Board
- Regulatory Submissions/Safety Plans/Risk Management
- Labeling Support
- Agency Visitations/Clinical
- Study Reports
- Protocols & Amendments
- Investigator Brochures
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Clinical/Medical Writing At A Glance
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- Clinical Study Summary Reports
- Abstracts and Posters for Clinical Studies
- Sales Force/Medical Science Liaisons
- Health Care Providers Correspondence (FAQs, SRLs)
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Doreen Lechner, PhD EVP Pharmacovigilance Client Services |
