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Pharmacovigilance Services

 

The stringent regulations on safety monitoring and their periodical revision have led to increased safety data collection, analysis and regulatory surveillance, and increased costs. Thus, Pharmacovigilance has become a critical phase in clinical development programs.

 

TCS’ Pharmacovigilance Services, backed by extensive knowledge of the drug development process and domain expertise, help you address these issues.

Client Challenges

  • Stringent and periodical revision of safety monitoring regulations
  • Increased cost of compliance

What TCS Provides 

We, at TCS, offer complete Pharmacovigilance Services, which include data collection, processing, medical review, safety writing, report writing, reporting, signal detection and analysis.

Our Pharmacovigilance Services help you ensure regulatory compliance, enhance efficiency and reduce costs significantly. We operate within a partnership model, where you benefit from our domain knowledge, global reach, quality systems approach, multi-disciplinary safety expertise and adherence to reporting timelines of the EMEA, FDA, MHRA and other competent authorities.

Business Value

  • More than 99% compliance with regulatory reporting timelines
  • Up to 10% reduction in error rates and an increase in percentage accuracy, with the implementation of six sigma projects: This has resulted in an increase in the number of cases that each person handles per day