Clinical Trial Services
Clinical Safety
A multi-disciplinary clinical background enables the group to provide effective process monitoring including collection and triage of all safety information throughout the trial.
HCRI’s clinical safety team provides guidance on all safety trial parameters from study inception through closeout and submission to regulatory bodies. Primarily, the team focuses on adverse events and serious adverse events during the establishment of a safety profile for the particular product under investigation. The group also builds upon pre-existing safety profiles as the product moves through the regulatory approval cycle and into the post-marketing arena. A multi-disciplinary clinical background allows the group to provide expertise in a variety of therapeutic areas.
Safety data collected throughout the trial is summarized by the group at HCRI and provided to the Data Safety Monitoring Board (DSMB) members or regulatory bodies as necessary. This cumulative review ensures that identifiable safety signals are directed to the appropriate authorities as soon as possible and additionally allows the safety group to notify the reviewing bodies of any potentially new and harmful safety signals that may occur throughout the trial.
HCRI’s clinical safety group is committed to providing an accurate and thorough safety profile through rigorous continual review of the clinical trial data. This review includes:
Safety data collected throughout the trial is summarized by the group at HCRI and provided to the Data Safety Monitoring Board (DSMB) members or regulatory bodies as necessary. This cumulative review ensures that identifiable safety signals are directed to the appropriate authorities as soon as possible and additionally allows the safety group to notify the reviewing bodies of any potentially new and harmful safety signals that may occur throughout the trial.
HCRI’s clinical safety group is committed to providing an accurate and thorough safety profile through rigorous continual review of the clinical trial data. This review includes:
- Protocol design and review
- Risk profile analysis and management plans
- Safety plan design and regulatory strategy in regards to safety data
- Presentation of safety data at Investigator meetings and regulatory meetings
- Serious Adverse Event (SAE) review and processing
- Design and maintain safety database to ensure collection of all protocol driven safety parameters
- Track, enter and follow all incoming SAEs until resolution in the Clintrace™ database
- Coding of all events
- Narrative writing
- Reconciliation of all SAEs
- Medical review of all SAEs
- Generate safety regulatory reporting documents and DSMB reports
- Perform periodic coding review of adverse events
- Review and generate safety sections for all interim, final and periodic safety reports
