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Drug Safety—Detection. Collection. Assessment. Monitoring.

Clinical research and patient support programs play a crucial role in the identification of real-world data that can impact a product’s development over time. Dosing or administration changes—and even new indications—can occur as a result of adverse events or product quality complaints that our pharmacovigilance experts detect.

Our pharmacovigilance services provide customizable solutions that are compliant with local regulatory requirements. We work with our clients to develop product-specific standard operating procedures for timely adverse event reporting, tracking and reconciliation. Our pharmacovigilance experts undergo extensive annual client-specific adverse event and product quality reporting training to ensure the specific requirements for timely reporting are met.

Our pharmacovigilance services include:

  • Adverse event detection and identification: Our proprietary software system uses sophisticated data analysis to detect potential safety concerns associated with our clients' products.

  • Case processing and reporting: We provide end-to-end case processing services, including case intake, triage, data entry, medical review and regulatory reporting. Our team follows strict quality standards and timelines to ensure timely and accurate reporting of adverse events.

  • Source data verification and adverse event reconciliation: Our source data verification processes ensure the accuracy and completeness of safety data. We offer adverse event reconciliation services to identify and resolve any discrepancies, duplicates or inconsistencies in the reported data.

  • Risk management planning and implementation: We work with our clients to develop risk management plans that are tailored to their specific products and target populations. Our team also provides support for the implementation of risk minimization measures.

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Adverse Event Tracking

Our adverse event (AE) tracking system is a customizable, fully integrated program for the collection and reporting of adverse events and product quality complaints. Program documentation is reviewed by our experts to identify issues, ensuring:

  • Error-free DSS reconciliations and source data verification (SDV) audits
  • Excellent record of client pharmacovigilance audit and supplier quality assessment results
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Our Experts

At the core of a strong team are a set of strong shared values. Our health team operates around values we believe help us build the best experience for patients, clients and the health care industry as a whole. Together, we are innovating patient care and impacting the lives of people every day.

Jeff Smith

Jeff Smith leads the Pharmaceutical Solutions division at Calian, overseeing CRO and PSP services. With more than 30 years of pharmaceutical development, regulatory and market access experience, Jeff brings a wealth of industry knowledge to bear upon our clients’ pharmaceutical and medical device products. In the 20 years preceding his tenure at Calian, he founded and simultaneously grew two pharmaceutical healthcare companies into multi-million dollar enterprises, and developed a healthcare ERP software application, now called Calian® Nexi, that uses digital automation technology to maximize the value of time. Jeff’s mandate is to leverage this experience and our technological solutions to reduce the friction of getting safe, high-quality products to market faster.

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Kaytlin Sadler

Kaytlin Sadler is the Vice President of Patient Solutions at Calian. She helps define and execute the patient support programs strategy and identify new business opportunities. Overseeing internal operations and building strong client relationships, Kaytlin has helped maximize operational pace to achieve real outcomes. Kaytlin played a key role in the strategic evolution of the Calian Nexi™ platform, an innovative ERP software that delivers a better healthcare experience today and is helping to shape where the industry is headed. In keeping with the division’s efforts to challenge and empower its employees, she has built a strong and confident team of diverse yet like-minded individuals.

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Patricia Moore

Patricia Moore is the Vice President, Contract Research Organization at Calian. With 19 years of experience, Patricia is responsible for operational management and business leadership. In her role, she works with clients across Canada to ensure the successful and efficient execution of their clinical trials.

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