Medical Monitoring and Safety

Medical Monitoring

Medical monitoring by a licensed physician is an essential function to ensure the safety of trial subjects and the clinical integrity of trial results. Our medical monitors possess substantial experience in all phases of clinical trials from protocol development to SAE reporting to regulatory submissions. You can be assured that your study will be conducted according to protocol, that your study subjects will be carefully monitored and that you will have immediate visibility into any potential issues or concerns.

Safety Surveillance

As part of Clinipace’s standard operating procedures, the study team will create a Safety Plan (SP). The SP will include the parties responsible for managing the safety process, including, monitoring by a license physician, as well as specific reference to SOPs and local guidelines to ensure proper management and reporting of adverse events.

Clinipace has experience managing global trials, and has local regulatory experience in the US, Latin America, and Europe.

Adverse Event Tracking

Clinipace provides access to tools and experience to provide a fully compliant and comprehensive drug/device safety program. From clinical trials safety to post-marketing surveillance, Clinipace Worldwide has experience managing data collection, triage, tracking, and reporting of adverse events.

Serious Adverse Event Tracking and Reporting of Events to Regulatory Authorities

All SAEs will be entered by the investigative sites into the TEMPO eClinical Platform, whereupon an automatic notification of the SAE will be generated and sent to the designated safety team via email. The safety team typically includes the assigned Medical Monitors, Safety Associates, Project Manager and Sponsor personnel as requested. Upon notification of the SAE, the Clinipace Safety Associate reviews the SAE report into TEMPO to determine if the report is complete and what additional information is required. Depending upon the site location, the local Medical Monitor or Safety Associate may contact the site to discuss the event or obtain additional information in local language.

The assigned Safety Associate and Medical Monitor will then make the determination if the event is reportable, e.g. unexpected and related to study treatment, and creates the narrative for each event. All events will follow the US 7 or 15 day reporting timelines as this is consistent with international requirements. The international requirements for each country are reviewed and implemented by the local Safety Associate and Medical Monitor. Clinipace has been managing Safety and reporting Serious Adverse Events internationally for over ten years in this manner.

Our experience includes:

  • CIOMS and MedWatch 3500A reporting
  • Global Periodic Safety Reporting (PADER, PSUR)
  • Provide support for ASR/DSUR
  • NDA and IND submissions (supporting preparation of IND/NDA Annual Reports, NDA ISS sections and Clinical Study reports)
  • Regulatory report submissions to appropriate authorities
  • Medication Error Reporting
  • Toxicology Report Management
  • Medical writing support for report generation
  • Other special reports required by regulatory authorities (e.g. risk management associated reports and other post-marketing commitments)

Aggregate PADER/PSUR Reporting including:

  • Tracking of reporting periods and submission dates
  • Generation of tables and listings from safety database
  • Analyze line listings and prepare relevant tables
  • Analyze previous aggregate reports for the product
  • Compose case summaries and analysis
  • Draft report for client review and approval
  • Medical review of each report