cdss

Pharmacovigilance

The Cornerstone for Risk Management

CDSS can provide a full range of Pharmacovigilance and Risk Management (PVRM) services for all study phases ensuring drug safety standards are being performed to the highest current standards on a regular basis.

Activities can include:

  • Protocol review and PV activities, including subject safety
  • Collating, reviewing and reporting Adverse Events (AEs)
  • Periodic reporting of collated AEs
  • Writing and submitting safety updates to ethical and regulatory authorities
  • Expedited reporting of suspected unexpected serious adverse reactions (SUSARs)
  • Writing and reviewing PV sections of study reports
  • Provide a seamless approach to drug safety for products undergoing both clinical and post-marketing assessments

 

 

 

 

 

 

 

 

The Art of Good Clinical Practice

Suite 5
Silk House
Park Green
Macclesfield
Cheshire
SK11 7QJ

UK +44 (0)1625
617447
US +1 508 293
4000
www.cdssltd.com

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