Pharmacovigilance

Outsourcing some or all aspects of your drug development cycle has become a standard part of drug development and marketing in the pharmaceutical industry. Identifying a specific customizable model that matches the needs and strategy of the organization is important for the success of your processes.

At Viltis, we offer comprehensive pharmacovigilance services to ensure drug safety across all phases of development and post-market monitoring. Our team of Drug Safety MDs and Drug Safety Specialists works to detect, assess, and prevent adverse drug reactions, ensuring regulatory compliance and patient safety.

Our pharmacovigilance services include:

Adverse Event Reporting and Monitoring

• Comprehensive Case Management: From initial data entry to regulatory submission, Viltis manages the lifecyle of Indvidual Case Safety Reports (ICSRs) to ensure compliance with the global standards such as ICH E2B (R3) and MedDRA coding.
• Data Integration and Automation: We utilize advanced pharmacovigilance databases that integrate data from various sources to automate case intake, duplicate detection, and follow-up processes.

Our team ensures all adverse event reports are processed in compliance with regulatory timelines (7-day and 15-day expedited reporting requirements) tailored to each region's regulations.

We also partner with MedMind, a digital health platform, to support real-time adverse event reporting, patient monitoring, and automated safety alerts for enhanced pharmacovigilance workflows.

Risk Management Plans (RMPs)

Viltis’ experts provide you the best advice to develop the RMPs for your clinical trials and also help you design the RMPs.

• RMP Development: Designing detailed Risk Management Plans (RMPs) that outline risk minimization strategies tailored specifically for your needs.
• Risk Minimization Measures (RMMs): Implementing RMMs, including educational materials for healthcare professionals, pregnancy prevention programs, and controlled distribution systems.
• Effectiveness Monitoring: We track the real-world effectiveness of RMMs through Post-Authorization Safety Studies (PASS) and periodic safety reviews, to make sure the continued benefit-risk balance of your product.

Post-Authorization Safety Studies (PASS)

• Study Design and Protocol Development: Our team designs and develops robust PASS protocols, employing methodologies such as cohort studies, case-control studies, and registries to address specific safety concerns.
• Real-World Evidence Generation: We collect and analyze real-world data (RWD) from diverse healthcare settings, including electronic medical records, claims databases, and patient registries, to generate comprehensive safety evidence.
• Regulatory and Ethical Compliance: Managing all aspects of PASS, including regulatory submissions, Institutional Review Board (IRB) approvals, and ongoing study monitoring to ensure compliance with Good Pharmacoepidemiology Practices (GPP).

Medical Literature Monitoring

• Automated Literature Surveillance: We utilize AI-driven tools for the continuous monitoring of global medical literature to ensure the timely identification of relevant safety information for your products.
• Data Extraction and Signal Detection: We extract relevant safety data, including case reports and clinical study results, and integrate it into pharmacovigilance systems for signal detection and further analysis.
• Regulatory Compliance Reporting: We make sure that all relevant literature findings are reported in line with regulatory requirements, including submission to systems like EudraVigilance, as part of your product’s pharmacovigilance obligations.

Vaccine Pharmacovigilance

• Enhanced Safety Monitoring: Our pharmacovigilance experts implement enhanced safety monitoring protocols specifically for vaccines, including active surveillance and cohort event monitoring.
• Adverse Event Following Immunization (AEFI) Reporting: We ensure accurate and timely reporting of AEFIs, including rare events such as Guillain-Barré syndrome and myocarditis, to national and global health authorities.
• Vaccine Risk Communication: We develop targeted communication strategies to inform healthcare professionals and the public about vaccine safety, addressing concerns related to newly identified risks and ensuring public trust.

Further services:

• Clinical Trials Adverse Event Processing
• Gap Analysis and Consulting
• ICSR Management
• Literature Surveillance
• Pharmacovigilance Audits
• Qualified Person for Pharmacovigilance (QPPV)
• Observational Study Design
• Strategic Consulting