Clinical Pharmacovigilance Services

We can provide full service Clinical PV Project Management

• Adopting a risk-based approach, utilizing Quality Management Systems (QMS) and Information Security Management Systems (ISMSs) we ensure risk identification and mitigation
• Transparent Governance structure with immediate escalation path
• 24/7 troubleshooting availability
• Agreed Service Level Agreements and Turnaround Times (TATs) with supporting Quality Monitoring
• Regular Safety Status Review meetings with stakeholders

We can author Safety Management Plans

• Define the Roles, Responsibilities, Processes, and Timelines for all clinical PV activities across all relevant Stakeholders
• Establish PV technology to be utilized for the study
• Ensure open lines of communication between all stakeholders
• Define timelines to meet all Safety Reporting Regulatory requirements

We can establish Safety Reporting System Strategy tailored to your study

• Help develop the safety section of your Clinical Study Protocol
• Define applicable Regulatory requirements
• Evaluate different solutions
• Set up of Serious Adverse Event (SAE) reporting lines and systems and appropriate training
• Implement easy to use ‘Smart’ Forms or electronic Case Report Forms (eCRF)

We can process SAEs and other reportable events as per Study Protocol requirements

• 24/7 case intake and reconciliation
• Preliminary medical plausibility and reportability classification (SUSAR) verified by Safety Physicians
• Automated process of case triage supported by validated, best-in-class PV technologies
• Data entry and quality medical review of each case
• Fully electronic and automated distribution and submission

We can carry out Case Medical Review and Assessment

• Case assessment to verify the correctness and medical plausibility of a causal relationship, expectedness, case reportability, verify queries, and adding medical inquiries
• Review medical coding and case narratives to ensure medical coherence
• Analysis of Similar Events (AOSE) as per Code of Federal Regulations Title 21, part 312.32
• An automated process for cumulative case review, including AOSE

We can support your Safety Submissions

• Expedited reporting of individual cases to National Competent Authorities (NCAs), Institutional Review Boards (IRBs) or Ethics Committees (ECs), and Investigators
• Pharmacovigilance report submissions performed through HA gateways, web portals, emails, fax, and provision of manual submission by local PV Responsible Person for applicable countries
• Set up of gateway connection(s) with main NCAs

We can provide a structured and automated process to support your Query Management

• Structured query management process
• Automated process for query reminders
• Simple query forms
• Close collaboration with medical and clinical team
• SAE reconciliation plan defined at study start up
• Reconciliation frequency adjusted per study

Using Regulatory Intelligence we can maintain current Safety Reporting requirements for Investigational Medicinal Products and Medical Devices

• Monitoring National Competent Authority websites across the globe, we provide a fast and efficient interpretation and assessment for any impact on procedures and strategy to minimize risk
• Practical knowledge of the most effective reporting methodology

We can conduct MedDRA and WHO DD Coding

• Provide an easily accessible MedDRA browser within the Safety Database
• Ensure auto-coding is available for an exact match
• Regular training of the latest dictionary updates
• All coding is checked and verified by an experienced Medical Reviewer

We can maintain Aggregate Safety Reports for your product(s)

• Maintain aggregate safety reports calendar for your product
• Produce Annual Safety Reports and/or Development Safety Update Reports (DSURs) as required along with the collaboration of data from clinical studies (completed and ongoing)
• Submission of DSURs to concerned stakeholders
• Analysis of IB changes during period and assess benefit-risk profile of investigational product
• Periodic Update Reports including cumulative line listings with a risk benefit assessment