Extensive Therapeutic Knowledge & Experience
Indero supports pharmacovigilance for dermatology, rheumatology, and a wide range of other therapeutic areas.
Pharmacovigilance services for any drug, biologic, or medical device in any indication.
Indero’s pharmacovigilance team assesses and manages drug safety to ensure regulatory compliance and mitigate risks associated with adverse events. Here’s an overview of our key pharmacovigilance services:
Indero supports pharmacovigilance for dermatology, rheumatology, and a wide range of other therapeutic areas.
When sites report SAEs or SUSARs to Indero’s pharmacovigilance unit, we respond in a timely, coordinated manner to ensure an up-to-date, compliant safety database.
Indero has over 25 years of experience in meeting sponsor expectations with high quality, compliant drug safety data. Tell us about your pharmacovigilance needs today.
Scientific discipline. Operational efficiency. Clinical development expertise. Our pharmacovigilance services provide the rigorous foundation, quality data, and expertise clinical trials need to ensure effective execution and on-time delivery.
“The expertise and motivation Indero brought to the table were pivotal to our success. From the initial synopsis development to the final stages of study conduct, the synergy between our teams was palpable and was underpinned by Indero’s strong relationships with sites, investigators, and KOLs.”
Senior Vice President,
Clinical Development
Rheumatology CROs, such as Indero, are essential in ensuring drug safety and regulatory compliance throughout the clinical development process. They contribute by closely monitoring adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs), particularly in chronic conditions where treatments may carry long-term risks. By using specialized safety management systems, CROs not only ensure real-time safety reporting but also help identify potential risks early, preventing delays in development. Their expertise in navigating regulatory reporting requirements ensures that safety data are communicated efficiently to regulatory bodies, facilitating smoother approval processes and ensuring patient safety at every stage of the trial.
Pharmacovigilance services are integral to maintaining drug safety and mitigating risks during clinical trials, ultimately supporting the drug development timeline. By continuously monitoring adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs), pharmacovigilance teams help identify potential risks early, allowing for timely interventions. This proactive approach ensures regulatory compliance and facilitates the submission of safety data to regulatory authorities within required timelines, helping to prevent delays in trial progression and product approval.
The key responsibilities of a pharmacovigilance team include:
Safety data collection and management: Gathering, processing, and maintaining comprehensive safety data from clinical trials
Adverse event reporting: Reporting SUSARs to regulatory bodies within required timelines
Risk assessment and management: Assessing potential risks related to adverse events and implementing strategies to mitigate them
Regulatory compliance: Ensuring that safety reporting aligns with local and international regulatory guidelines (e.g., FDA, EMA)
Safety reviews: Conducting ongoing safety reviews of trial data, including coding of adverse events, and providing feedback for improving safety protocols
Narrative writing: Writing detailed narratives for safety reports, helping to communicate the context and implications of adverse events clearly
| Compliance Area | Indero’s Approach |
|---|---|
| Safety Data Management | Utilizing Oracle Argus Safety to ensure compliant safety data management, aligned with ISO 9001, ISO 27001, and other relevant certifications |
| Reporting to Regulatory Authorities | Expedited reporting of SAEs, SUSARs, and other events to FDA, EMA, Health Canada, and IRBs within regulatory timelines |
| Regulatory Submissions | Preparing and submitting accurate CIOMS/MedWatch/XML reports to meet regulatory expectations |
| Case Reconciliation | Ensuring alignment between safety and clinical databases for consistent reporting and analysis |
| Compliance Audits and Reviews | Conducting regular reviews and audits to ensure compliance with both internal and regulatory standards |
Wherever
You’re Going,
We’re all in.
Need help with your next study? We want to learn more. Fill out the form on the right and one of our experts will be in touch.
Jeff Smith, Chef de la direction d’Indero Recherches, apporte près de 30 ans d’expérience dans l’industrie pharmaceutique et CRO, s’étant distingué par son leadership exceptionnel, sa vision stratégique et son innovation. L’expertise de Jeff couvre des opérations mondiales, la gestion de la croissance, ainsi que la promotion d’une culture d’entreprise collaborative. Ses atouts en matière de création de valeur, de gestion des partenaires et d’opérations CRO ont toujours contribué au succès dans ses fonctions précédentes. Sous la direction de Jeff, Indero continue d’étendre ses capacités, faisant progresser les connaissances médicales et les nouvelles thérapies en dermatologie et en rhumatologie.
