Global Pharmacovigilance Solutions

Pharmacovigilance that scales with your pipeline. From clinical trials to post-marketing, we deliver end-to-end pharmacovigilance services designed for agility, accuracy, and compliance. Our inspection-ready systems are built around globally accepted frameworks such as ICH-GVP and 21 CFR Part 11, so that: the data stays protected, processes stay compliant, and drug safety runs seamlessly from start to finish.

Patient safety begins with trust, and trust begins with data that tells the truth.

Or as we like to say that pharmacovigilance is science of vigilance in an age of change.

As medicine becomes more precise and data more dynamic, the responsibility to keep patients safe has never been greater. Our Pharmacovigilance systems are built to match this evolution, we bring agility, compliance, and compassion together to connect data quality, medical insight, and regulatory integrity to ensure that innovation never outpaces safety.

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literature screenings

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Global Regulatory Compliance

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Years of team experience

28 Countries

A global footprint, connecting markets from China and Australia to Europe, Africa, Canada, and the United States.

Pharmacovigilance Safety Monitoring in Clinical Trials

When it comes to clinical development, vigilance means precision. Our teams provide end-to-end clinical trial safety management, ensuring all safety events are accurately captured, evaluated, and communicated to investigators and global regulators. Whether it’s first-in-human or late-phase studies, our goal remains constant: to help you balance risk and benefit while protecting every participant who makes clinical research possible.

Post-Marketing Pharmacovigilance

As your drug’s journey transitions from controlled trial environments to the real world, our post-marketing PV systems ensure every new data point, from spontaneous reports to global literature, feeds back into a compliant, actionable safety framework. Our systems are built to meet that demand with the same precision, responsiveness, and commitment to patients

Everything Pharmacovigilance, in one place

Clinical Trial Safety

Every data point in a clinical trial represents a volunteer who placed their trust in science. Our PV team ensures that every adverse event is captured, reviewed, and reported with care – protecting participants and supporting regulatory timelines worldwide

  • SAE & SUSAR processing
  • Urgent Safety Measures (USM)/ Significant Safety Information (SSI)
  • Safety data review in clinical protocols
  • Safety Management Plans (SMPs) and start-up documentation
  • EDC integration (eSAE tool)
  • Communication with investigators and clinical team
  • SAE reconciliations

Case Processing & Data Management

Every data point in a clinical trial represents a volunteer who placed their trust in science. Our PV team ensures that every adverse event is captured, reviewed, and reported with care – protecting participants and supporting regulatory timelines worldwide

  • SAE & SUSAR processing
  • Urgent Safety Measures (USM)/ Significant Safety Information (SSI)
  • Safety data review in clinical protocols
  • Safety Management Plans (SMPs) and start-up documentation
  • EDC integration (eSAE tool)
  • Communication with investigators and clinical team
  • SAE reconciliations

Aggregate Reporting & Risk Management

Every data point in a clinical trial represents a volunteer who placed their trust in science. Our PV team ensures that every adverse event is captured, reviewed, and reported with care – protecting participants and supporting regulatory timelines worldwide

  • SAE & SUSAR processing
  • Urgent Safety Measures (USM)/ Significant Safety Information (SSI)
  • Safety data review in clinical protocols
  • Safety Management Plans (SMPs) and start-up documentation
  • EDC integration (eSAE tool)
  • Communication with investigators and clinical team
  • SAE reconciliations

Signal Detection & Safety Surveillance

Every data point in a clinical trial represents a volunteer who placed their trust in science. Our PV team ensures that every adverse event is captured, reviewed, and reported with care – protecting participants and supporting regulatory timelines worldwide

  • SAE & SUSAR processing
  • Urgent Safety Measures (USM)/ Significant Safety Information (SSI)
  • Safety data review in clinical protocols
  • Safety Management Plans (SMPs) and start-up documentation
  • EDC integration (eSAE tool)
  • Communication with investigators and clinical team
  • SAE reconciliations

Post-Marketing Safety & Regulatory Compliance

Every data point in a clinical trial represents a volunteer who placed their trust in science. Our PV team ensures that every adverse event is captured, reviewed, and reported with care – protecting participants and supporting regulatory timelines worldwide

  • SAE & SUSAR processing
  • Urgent Safety Measures (USM)/ Significant Safety Information (SSI)
  • Safety data review in clinical protocols
  • Safety Management Plans (SMPs) and start-up documentation
  • EDC integration (eSAE tool)
  • Communication with investigators and clinical team
  • SAE reconciliations

Safety Systems & Technology Management

Every data point in a clinical trial represents a volunteer who placed their trust in science. Our PV team ensures that every adverse event is captured, reviewed, and reported with care – protecting participants and supporting regulatory timelines worldwide

  • SAE & SUSAR processing
  • Urgent Safety Measures (USM)/ Significant Safety Information (SSI)
  • Safety data review in clinical protocols
  • Safety Management Plans (SMPs) and start-up documentation
  • EDC integration (eSAE tool)
  • Communication with investigators and clinical team
  • SAE reconciliations

Our Technology: In-House PV safety database

VINCURA, our in-house Pharmacovigilance tech, streamlines PV operations with configurable workflows and audit ready outputs. Features include triaging/duplicate checks, ICSR processing, MedDRA coding, medical assessment, literature automation, line listings, tabulations, CIOMS/MedWatch/XML exports, and comprehensive audit trails. It supports easy data migrations (XML/E2B), ensuring continuity during vendor or platform transitions.

A transparent, inspection ready workflow

Inputs
  • Spontaneous reports
  • Literature
  • Regulatory
  • Partners/Affiliates
  • Clinical trials
  • Digital media
Processing
  • Case receipt & triage
  • Data entry & coding
  • Narrative
  • Medical review
  • Quality review
Outputs
  • Expedited regulatory submission (E2B, CIOMS, MedWatch)
  • Aggregate reporting
  • Signal generation & evaluation

We Built This Team for You

Our team is ready for What’s Next in Pharmacovigilance. A team that’s not just skilled for today but prepared for tomorrow.

  • Global teams across India, the USA, and the EU working as one connected network
  • Experts trained to balance compliance, technology, and clinical insight
  • Cross-trained across Aris-G, Argus,, and evolving digital safety systems
  • Experience across thousands of SAE/AE cases, literature reviews, and ICSR submissions
  • A culture built on continuous learning, inspection readiness, and shared accountability