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ISS, Inc. can function as your Drug Safety Department.
- Complete Serious Adverse Event (SAE) Handling
- Expedited Reports (MedWatch/CIOMS forms)
- Creation and Maintenance of a validated E2B-compliant SAE electronic database
- CIOMS Line Listings
- Benefit-Risk Assessments
- Registries
- Phase IV Studies
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Medical Monitoring and Consulting
ISS, Inc. will put its experience to work for you by
- Providing 24/7 Physician Coverage
- Determining Subject Eligibility for Clinical Trials
- Reviewing Study Protocols and Informed Consents
- Reviewing Serious Adverse Events (SAEs)
- Performing a Medical Review of NDA Documents and Clinical Study Reports
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Medical Writing
ISS, Inc. researches and develops various clinical documents including
- Standard Operating Procedures
- Investigator's Brochures and Updates
- Investigational New Drug (IND) and IND Annual Reports
- Clinical Study Reports
- Journal Publications
- SAE Narratives
- NDA Summaries: Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), Clinical Pharmacology, Benefit/Risk, and Non-Clinical Pharmacology and Toxicology
- Literature Reviews
- 120-Day Safety Update Reports
- Post-Marketing Periodic Safety Update Reports (PSURs) and Periodic Adverse Drug Reaction (ADR) Reports
- Written Responses to Regulatory Questions
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NDA and Regulatory Activities
ISS, Inc. will work with you to achieve on-time submissions by providing
- Management and Strategic Planning throughout the NDA Process
- Pre-NDA Meeting Packages
- Document Outline, List of Tables and Table Shells for the ISS, ISE, and Clinical Pharmacology Sections for your NDA
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Coding
ISS, Inc. will put its coding expertise to work for you by
- Coding Adverse Events (MedDRA, COSTART, WHO-ART), Concurrent Medical Conditions (MedDRA), and Medications (WHO-DRL)
- Reviewing Codes and Ensuring Coding Consistency
- Coding of Legacy Data to MedDRA
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Training
ISS, Inc. will customize a training program for Medical Writers/Editors, Clinical Research Associates, Regulatory Associates, Programmers, Statisticians, Clinical Research Scientists, and Medical Monitors. Current courses offered include
- Presentation and Interpretation of Safety Data for Clinical Study Reports and the IntegratedSummary of Safety
- Basics of the Integrated Summary of Safety
- Subject Narratives
- Clinical Significance of Laboratory and ECG Abnormalities
- Safety Monitoring and Pharmacovigilance: A Physician's Perspective
- Risk Management
- MedDRA
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Integrated Safety Systems, Inc. (ISS, Inc.) is a team of proactive professionals whose primary focus is the management, evaluation, and documentation of pharmaceutical, biologic, and medical device safety.
We offer comprehensive services including Pharmacovigilance and Risk Management, Medical Monitoring and Consulting, Medical Writing, New Drug Application (NDA) and Regulatory Activities, Coding, and Training. By performing safety-related functions during clinical development (through the NDA process
and in the post-marketing phase), we establish long-term relationships with small-, mid-, and large-sized pharmaceutical and biotechnology companies.
By utilizing our cumulative knowledge and expertise, our clients can expect deliverables on time, within
budget, and meeting or exceeding expectations.
The ISS, Inc. logo depicts the company's primary focus for solution-oriented results. The logo illustrates the answer to a puzzle requiring that four continuous lines connect nine dots. The only way to solve the puzzle is to draw the lines outside the box. The colors of the logo are gray and blue. The gray represents problems, where the solution is usually neither black nor white; the blue is a reminder that sometimes one has to do blue-sky thinking to solve a problem. This logo was designed by Polloni Design, Inc.
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