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Drug Safety

Comprehensive Drug Safety Solutions

ClinChoice has an entire suite of drug safety solutions to ensure patient interests remain a priority during a drug’s lifecycle. With a strong understanding of regulations, our team of experts is at the forefront of providing analysis and generating insight that improves the quality of life. At ClinChoice, we are dedicated to advancing patient safety research with data, drive, and decisiveness.

Case Processing

Our team of safety experts manages end-to-end case processing capabilities that are the foundation of advanced safety analytics. We use domain expertise and technology to reduce processing times and ensure compliance at every step.

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Aggregate Report Development and Submission

Our authors and quality reviewers help the development of periodic and ad-hoc reports for every phase of drug development and post-marketing. We manage the entire spectrum of activities that lead to the creation and submission of first-time-right reports.

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Signal Management

Our safety scientists pore through every element of adverse event data to identify patterns and propose new safety information and activities triggered by the discovery of a new signal.

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Literature Monitoring

Our team of literature reviewers uses carefully crafted search strategies to screen global and local literature to identify adverse events that contribute to case processing, aggregate report authoring, and signal management.

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Risk Evaluation & Mitigation

Our safety specialists evaluate and author safety risk evaluation and mitigation strategies and plans for innovator and generic drug applications.

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Safety Data Exchange Agreements

Our team of contract experts creates and maintains agreements in compliance with local health authority requirements and monitors the partners’ adherence to their commitments.

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Pharmacovigilance System Master File Management

Our pharmacovigilance quality specialists ensure that the PSMF is up-to-date, reviews existing processes for compliance, and maintains the necessary documentation to support health authority evaluations.

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Medical Information Call Center Solutions

Our highly-trained product and safety specialists evaluate information requests to identify adverse events and product quality complaints and provide accurate responses to support physicians and patients.

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Local Safety Officers

Our local safety officers with country-specific regulatory knowledge oversee local case processing, review safety reports, compliance monitoring, inspection support, PSMF maintenance, and establishment of local PV processes, among other functions.

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