Automated Safety Reporting Systems: A leap to advancement in Pharmacovigilance

Regulatory deviations that need major corrective actions require huge investment in terms of resources as well as time. Instead, it is always better to be SAFE THAN SORRY.
To put it simplistically, ‘NO LOSS’ is also a big-time gain when it comes to clearing audits and inspections as well as winning clientele and consumers trust!
The intricacies of a human body are still being explored and every day we discover new facts. When a drug is added to such a complex human organ system, there are all possibilities it is bound to fetch something unknown and pivotal as each human system is unique.

Intense resistance was witnessed when computers entered the industry as a break-through systems to reduce rather, share the work load of human processes, referred to as technophobia.
Similarly, there is a long pause in bridging the gap between human-driven systems and full-proof electronic safety submissions with a chunk of industry segment still in its nascent stage to adapt to this dire need and move ahead with substantial modifications in existing system.
Emphasis is needed on pharmacovigilance reporting that portray a world inclined towards safety submissions without a second’s delay. We ought to promise a world to safer medicines by techno savvy adverse event management.
This can undoubtedly be ascertained by all means through digitalized safety submissions.
Even an early warning ‘Signal’ can change the identity of a medicinal product, if validated and proven to be so!
Why electronic safety data submissions are the need of an hour ?
The points listed below will lucidly be the MIND CHANGERS!

  • Key to accurate, precise, guideline-compliant reporting
  • Most Sponsors favoring outsourcing industry that are techno-friendly
  • Compliance to Regulatory inspections
  • Acquiring favorable trends in safety audits
  • Facilitates Signal identification and evaluation – barely reportable otherwise
  • Negligible data entry errors
  • Tracing accountability
  • Time-saving due to automated case entry into specific data fields,
  • Prompt safety compliance measures can be taken to safeguard public health

Digitalized pharmacovigilance reporting can certainly do lot more than a human mind can think of!
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