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Medical Monitoring and Patient Safety

ClinDatrix upholds the highest standards when conducting clinical trials placing patient safety as the top priority.  The Medical Safety department has experienced MDs and other qualified safety personnel to provide medical expertise for your studies.  ClinDatrix employs the Oracle Argus Safety System software to collect, monitor, and manage safety data. This platform allows secure, real-time access to data and reporting tools for Pharmaceutical, Biologics, and Medical Devices throughout all phases of clinical research; pre-approval to post-market.  ClinDatrix also has the tools and processes to handle safety surveillance and pharmacovigilance needs.

  1. Medical Monitoring

    2. The Medical Monitors promote every aspect of patient safety through internal and external project teams.  The Medical Monitors oversee product safety and process Serious Adverse Event Reports using the Oracle Argus Safety Reporting System.  Medical Consultation is available 24/7 to assist in review and evaluation of event collection and reporting. Medical Monitors can assist a sponsor with data analysis, clinical study reports, and regulatory submissions.  In addition, they can provide site education and training for a study team on different medical/disease states, treatments, procedure labs, protocol compliance, and potential study issues.

  2. Protocol Waiver and Compliance Assessment

    3. The Medical Safety team will monitor major or minor Protocol Deviations / Violations.  Exceptions will be secured through a written approval of the Sponsor.

  3. SAE Surveillance (24 hour / 7 day coverage available)

    4. The ClinDatrix SAE Reporting System is in place using multiple modes of communication:  telephone, FAX, e-mail, e-SAEF (electronic SAE forms completed in an electronic data capture system).

  4. Medical Devices

    5. The Medical Safety team can assist you by providing consultation services for your Medical Device needs regarding Investigational Device Exemptions (IDEs), Pre-market Approval of Medical Devices (PMAs), Medical Device Reporting (MDR) of Adverse Events, Medical Device Safety Vigilance and Incident Reporting.

  5. Lab Safety Review Including Lab Alerts

    6. The Medical Safety team is experienced in reviewing laboratory safety issues and generating Lab Alerts (if needed) to all Investigators involved in the study. The Medical Safety team will regularly monitor patient lab results and will promptly inform the sponsor and/or Investigators of any significant laboratory or clinically findings.

  6. Medical Data Review

    7. The Medical Safety team can assist a sponsor with the review of medical data that can be collected electronically and/or manually.

  7. Medical Coding

    8. The Medical Safety team has experienced medical coders to provide MedDRA and WHO Drug coding.

  8. Scientific Advisory Boards and Drug Safety Monitoring Boards (DSMB)

    9. The Medical Safety team will oversee the generation of medical data in the forms of safety listings to be used at Scientific Advisory Boards and Data Safety Monitoring Board meetings.

  9. Patient Registries

    10. The Medical Safety team can provide accurate and comprehensive patient registries with the assistance of the Data Management, Biostatistics, and Clinical departments.

  10. Endpoint Adjudication

    11. Working with the Data Management, Biostatistics, and Clinical departments, the Medical Safety team will prepare and write Critical Event Committee (CEC) procedure manuals, set up and implement the data collection process for endpoint data, prepare patient reports for the CEC to be reviewed remotely and during face-to-face meetings, organize and assist the CEC during face-to-face meetings, and track the endpoint adjudication status for each potential endpoint.

  11. Special Projects  

    12. The Medical Safety team can assist a sponsor with the reconciliation of SAE with AE data.  The Medical Safety team can provide Medical Safety support to Regulatory Affairs during Food and Drug Administration and/or European Medicines Agency meetings. ClinDatrix can provide Chief Medical Officer services for sponsors without medical personnel.  In addition, Medical Safety can generate Periodic Safety Reports, develop and implement Safety / Surveillance Programs, provide Pharmacovigilance and Medical Information Hosting Services, manage Medical Information and Complaint Reporting Call Centers (consumer complaint tracking and reporting), manage Medical Information Services for distribution of  “peer-to-peer” communication, provide Literature Review services and Medical Publication reviews, assist in Aggregate Report Processing – Periodic Safety Update Reports (PSURs), Addendum PSURs, Summary Bridging Reports, and SUSAR Reports.

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