INNOVADERM CRO IS NOW INDERO.

Pharmacovigilance (Drug Safety) Services

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

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 Responsible Person for Eudravigilance on behalf of the Sponsors.

Extensive Therapeutic Knowledge & Experience

Indero supports pharmacovigilance for dermatology, rheumatology, and a wide range of other therapeutic areas. 

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.

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.

“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

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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.

Is Now

We are excited to announce that Innovaderm is rebranding our CRO division as Indero (in-dAIR-oh). This rebranding reflects our ongoing commitment to innovation and our expansion into the field of rheumatology, a therapeutic area closely linked to dermatology. As a dual-focus CRO specializing in both dermatology and rheumatology, this strategic decision marks a significant milestone for our organization, and we are eager to embark on this new chapter with our valued partners and clients. Innovaderm will continue to operate as a CRU for dermatology studies.

Site Selection & Management

Our long-standing relationships with key opinion leaders and highly performing sites, result in optimized start-up processes that deliver strong results in the least amount of time. As part of our site evaluation, our team utilizes past performance metrics, recruitment projections based on competitive landscape, and detailed feasibility surveys to determine a site’s capabilities and interest in a study.

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Patient Recruitment

Our dedicated patient recruitment and advertising team integrates with the study team to tailor recruitment strategies, customize central ad campaigns, develop advertising creative, and continuously track and adapt recruitment goals. Our patient-centric approach is enhanced by Clinago, our technology enabled recruitment service.

PROJECT MANAGEMENT

We orchestrate all study activities and deliverables, including site selection process, budget and contract negotiations, and patient engagement, recruitment enrollment projections, all while respecting your study timelines.

PROJECT MANAGEMENT

We orchestrate all study activities and deliverables, including site selection process, budget and contract negotiations, and patient engagement, recruitment enrollment projections, all while respecting your study timelines.