Safety & Pharmacovigilance

Proactive | Thorough | Effective

Safety & Pharmacovigilance

Safety & Pharmacovigilance

Proactive | Thorough | Effective

Trending

Trending

Increasing hazards associated with adverse drug reactions have brought pharmaceutical companies under immense pressure to manufacture safer drugs and monitor their effects to ensure patient safety.

As the industry is shifting from reactive to proactive safety and pharmacovigilance measures, manufacturers are scaling their internal practices to meet global regulatory expectations. Pre-marketing surveillance involves data collection regarding adverse drug reactions from the pre-clinical screening to phases III clinical trials. Linking pre-marketing with human safety information is one of the emerging trends in pharmacovigilance outsourcing.

Trending
Opportunities & Challenges

Opportunities & Challenges

Opportunities & Challenges

Increasing complexities for drug safety and monitoring, volume surges, and evolving regulatory standards are key challenges for drug manufacturers.

Pharmacovigilance (PV) of clinical trials and identifying the safety information from limited controlled patient information is a challenge. Mature PV processes and domain experts are required to analyze clinical trial data to identify product signals/risks. Small and medium-sized companies rely on contract research organizations for performing PV activities as they do not have a separate facility to ensure drug safety. To reduce the cost and increase the efficiency of the PV processes, pharmaceutical companies are looking for an end-to-end PV outsourcing model.

Service Offerings

Safety & Pharmacovigilance
Service Assets
  • An interdisciplinary team of drug safety physicians, QPPV, PV SMEs, and regulatory experts

  • Standard SOPs & customizable templates

  • Custom AI solutions

  • Ecosystem: Partnerships & alliances

Differentiators

  • Homegrown automation and intelligence platform for quick turn-around time and improved operational efficiency

  • End-to-end pharmacovigilance service portfolio ensuring meticulous quality control and timely submissions

  • Expert program and project managers for setting up processes, and training employees as per local and global regulatory requirements for effective management of volume surges

  • Agile processes, domain expertise, and robust written SOPs for ensuring streamlined PV services

Benefits to the Customer

  • Improved benefit-risk assessment of the drugs & risk management programs leading to improved patient outcomes

  • Faster & real-time detection of safety signals leading to the optimum use of therapies & enhanced patient safety

  • Rigorous & proactive data collection and processing to further improve manufacturers’ ability to promote & protect patient health and wellbeing

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