We're diligent, observant, and accountable to ensure safety.

Efficacy and safety are the two factors that determine the commercialization potential of a new drug. Safety of new drugs is a growing concern in many therapeutic areas where safe and effective drugs are available for patients who need them. On the other side of the spectrum, for rare diseases, safety often prohibits the distribution of drugs to desperate patients. The increase in side effects, scrutiny by healthcare providers and regulators and negative results for patients mean that biotech and pharma are paying even greater attention to product safety in their research, early development, and ongoing study implementation.

At PSNResearch, the detection, assessment, understanding and prevention of adverse effects is a principal concern and significant area of expertise. Our management processes, combined with our accountable one point-of-contact on your trial, are in place to enable the identification, documentation, and analysis of safety information. We identify safety signals quickly, so an appropriate response is formulated and made. Your contact at PSNR manages your responsibilities to regulators and provides the assessments that are required to reduce risk and deliver the best chances of regulatory approval.

Adverse Events and Serious Adverse Events

  • Assessment
  • Medical review
  • Narrative writing

Safety Reporting

  • Expedited and periodic
  • Signal detection and analysis
  • Literature monitoring

Data reconciliation of safety and clinical trials databases

  • MedDRA and WHO drug dictionary coding