INNOVADERM CRO IS NOW INDERO.
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Pharmacovigilance (Drug Safety) Services

Pharmacovigilance services for any drug, biologic, or medical device in any indication.

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Drug Safety Team Members

0 +
 Years of Experience
1 +
Clinical Trials
475 +

Manage Safety with Expert Pharmacovigilance Capabilities

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:

  • Develop a fully compliant safety management plan along with the reporting forms and completion guidelines
  • Implement and validate Oracle Argus Safety in collaboration with the cloud host, ensuring compliance with ISO security and quality certifications, including ISO 9001, ISO 27001, ISO 27017, and ISO 27018
  • Collect and manage safety data, including triage, processing, and management of serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and other safety records
  • Writing of narratives and analysis of similar events (AOSE) as applicable
  • Migrate legacy data into Argus Safety
  • Expedited reporting to EudraVigilance (EMA), FDA, Health Canada, IRB, and other regulatory authorities
  • Maintain a case tracker for SAEs, SUSARs, pregnancy cases, overdose cases, and other applicable events
  • Generate CIOMS/MedWatch/XML reports electronically and distribute them to the sponsor or regulatory team, including cross-reports
  • Reconcile the safety database with the clinical database in collaboration with the data management team
  • Conduct safety reviews of coding at planned intervals
  • Prepare Development Safety Update Reports (DSURs)
  • Registration of IMP in XEVMPD for trials in Europe
  • Act as the Responsible Person for EudraVigilance on behalf of the Sponsors

Celebrating 25 years of therapeutic Excellence

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SAE & SUSAR Management

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.

  • Notify sponsor within 1 business day following data entry in safety database
  • Determine expectedness in consultation with study sponsor
  • If SUSAR, we handle submitting final CIOMS/MedWatch/XML to regulatory authorities, investigator sites, and the central or local IRB

Partner with Indero’s Pharmacovigilance Team

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.

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Pharmacovigilance Services that Accelerate Studies

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.

ABOUT INDERO

“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.”

Snehal Naik, PhD

Senior Vice President,
Clinical Development

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.

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Jeff Smith

Chef de la direction

Jeff Smith, Chef de la direction d’Indero Recherches, apporte prĂšs de 30 ans d’expĂ©rience dans l’industrie pharmaceutique et CRO, s’Ă©tant distinguĂ© par son leadership exceptionnel, sa vision stratĂ©gique et son innovation. L’expertise de Jeff couvre des opĂ©rations mondiales, la gestion de la croissance, ainsi que la promotion d’une culture d’entreprise collaborative. Ses atouts en matiĂšre de crĂ©ation de valeur, de gestion des partenaires et d’opĂ©rations CRO ont toujours contribuĂ© au succĂšs dans ses fonctions prĂ©cĂ©dentes. Sous la direction de Jeff, Indero continue d’étendre ses capacitĂ©s, faisant progresser les connaissances mĂ©dicales et les nouvelles thĂ©rapies en dermatologie et en rhumatologie.

Revolutionize Your Topical Trials

Efficacy insights in days, not months.

 Indero’s Early Phase 1 model enables sponsors to initiate topical studies that detect early pharmacodynamic signals much sooner than traditional phase 1, using microdosing and transcriptomic analysis. This approach reduces preclinical requirements, shortens study duration from 8–12 weeks to ≀3 days, and lowers costs, helping teams make informed go/no-go decisions faster.
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