Integrated Safety Systems, Inc.

“Specializing in Pre- and Post-Marketing Pharmaceutical Safety and Surveillance”

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We can help you streamline your safety reporting tasks and complete your projects on time and within budget! To learn more about our company and the services we offer, select a topic from the following list.

Geriatric Use Labeling Revisions

The staff of ISS, Inc. can manage, compile, analyze, and summarize geriatric safety data for your products which require revised/new geriatric use labeling. (See Federal Register notice January 21, 1999 and Guidance Document. Please note that this draft guidance is in Adobe Acrobat format!)

Services include:

4 Review of clinical trial and post-marketing safety surveillance data to identify appropriate geriatric data for summarization

4 Literature review to identify sources of non-sponsor-generated safety data

4 Management of data analysis

4 Preparation of written geriatric safety report

4 Preparation and/or review of labeling revisions generated from written geriatric safety report

4 Preparation and/or review of NDA supplement transmitting proposed labeling changes to FDA (CDER or CBER)

The Integrated Summary of Safety and the 120-Day Safety Update

The staff of ISS, Inc. can provide upfront, strategic planning for your Integrated Summary of Safety and your 120-day Safety Update. We offer total ISS management and supervision, including:

4 Preparation of ISS table shells and document outline

4 Pre-NDA meeting packages and support

4 Interstudy standardization of adverse event, coexisting disease, and concomitant medication coding

4 Reconciliation of clinical trial and serious adverse event databases

4 Preparation of narratives for serious adverse events and discontinuations due to adverse events

4 Management, supervision, and quality control of ISS table programming and population

4 Writing, editing, and QC

4 M.D. review and editing

Other Safety Documentation and General Medical Writing

The staff of ISS, Inc. are experienced in the preparation of Phase 1-4 clinical reports, NDA clinical and toxicological summaries, INDs, and other safety documentation. Call us for more information about these services:

4 Investigator Brochures and Updates

4 INDs and IND Annual Reports

4 Clinical Study Reports

4 Subject Narratives of Serious Adverse Events and Adverse Events Leading to Discontinuation

4 Publications

4 MedWatch 3500-A and CIOMS 1,2

4 Post-Marketing Safety Update Reports

4 NDA Summaries: ISS, ISE, Benefit/Risk, Non-Clinical Pharmacology and Toxicology