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Using only qualified medical doctors with extensive experience in drug and medical product safety, ISS, Inc. provides a complete range of medical monitoring and medical consulting services, including:
- 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/Registration and Clinical Study Reports
- Analysis of Medical Product Safety Protocol
- Benefit-Risk Assessments
- Identification of Safety Signals
- Assist in Response to Regulatory Authorities Regarding Safety Issues
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