Medical Monitoring

Medical Monitoring, Pre-Marketing and Post-Marketing Safety Surveillance

The staff of ISS, Inc. can assist you with the total management of your pre- and post-marketing safety surveillance. Are you running at less than maximum efficiency? Try our “Safety Department Tune Up”, an in-depth addiction treatment analysis and assessment of your department’s structure and workflow! Other services include:

4 Production, review, and editing of safety surveillance SOPs

4 Global harmonization of serious adverse event databases

4 Capture and review of serious and other important residential drug treatment medical events

4 Coding and review of coding of serious and other important medical events

4 Medical review of protocols and case report forms

4 Medical monitoring and ongoing safety review by Michael J. Klepper, M.D.
(24-hr clinical trial coverage)

4 Identification of safety signals, and trend analyses

4 Preparation of IND annual reports and post-marketing safety update reports

substance abuse treatment