Video modal
popup modal
The MHICC is now Seriant !
The Montreal Health Innovations Coordinating Center (MHICC) is now Seriant.
Our new name reflects a bold step forward— expanding beyond cardiology and embracing innovations in clinical trials with a global reach.
While our identity has evolved, our commitment to operational excellence, client satisfaction, and quality remains the same.
Pharmacovigilance
At Seriant, you gain a knowledgeable and experienced team dedicated to safeguarding the well-being of study participants and proactively managing safety with expertise and precision.
Our pharmacovigilance team provides continuous assessment of risks and benefits for drugs, vaccines, and medical devices via the collection, reporting, and analysis of all safety information, pre- and post-approval.
By leveraging advanced tools like AI and the LifeSphere® multivigilance reporting & analytics platform, safety reporting is rendered more efficient.
Our end-to-end pharmacovigilance and medical device vigilance services are available as an integral component of a full-service contract or as an à la carte option tailored to your specific needs.
Through our tools and expertise, the process of managing adverse event reports from initial intake through medical review and regulatory submission is seamless.
- Contact Person for Safety Matters (24/7)
- Case Intake (Receipt and Triage)
- Case Validation
- Coding of Drugs/Devices and Adverse Events
- Seriousness, Causality, Expectedness Assessment
- Case Narrative Writing
- Medical Review of Safety Data
- Quality Control Review
- Case Submission
- Case Maintenance and Follow-Up
At Seriant, we are your trusted source for end-to-end safety reporting and analysis throughout the project lifecycle, and beyond. We support pre- and post-marketing reporting to provide a comprehensive overview of a product's safety profile.
- Developmental Safety Update Report (DSUR)
- Periodic Safety Update Report (PSUR) or Periodic Benefit-Risk Evaluation Report (PBRER) and any associated addendums
- Periodic Adverse Drug Experience Report (PADER)
- Pharmacovigilance Risk Management Plans (RMPs)
We deliver proactive safety surveillance by identifying, evaluating, and prioritizing potential safety risks, ensuring informed decision-making and regulatory compliance in clinical trials.
- Signal Detection
- Signal Validation
- Signal Prioritisation
- Signal Assessment
- Exchange of Information
- Data driven recommendations for actions
We provide proactive pharmacovigilance risk management to ensure product safety through strategic planning, active mitigation, and continuous evaluation over the course of a product’s development.
- In-house leadership and expert guidance to all stakeholders
- Development of study specific Risk Management Strategies and methods for data surveillance
- Ongoing risk assessment, mitigations and efficacy checks
- Seamless integration within our localized project teams and external stakeholders
Interested in this service?
Let’s work together!
