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PV & Medical Monitoring

R&G has access to both in-house and a network of Medical Monitors with extensive knowledge, experience and training in a wide range of Therapeutic Areas, able to provide comprehensive medical review and medical management of your entire clinical trial.

Our Medical Monitoring Services Include:

  • Product Development planning
  • Document design, review and sign off from a medical point of view (Investigator Brochure, Protocol, CRF, Informed Consent, Study Manual, Statistical Analyses Plan, Data validation Plan, Study Reports, SAE narratives)
  • Study decisions regarding in/exclusion deviations, dosing questions, concomitant medication requests, emergencies (including 24/7 coverage)
  • Listing review of study data (demographics, physical exams, vitals, dosing, labs, EKG, concomitant medications, adverse events, efficacy parameters, protocol deviations) and cross referencing critical data fields for consistency
  • Coding review with medical judgment
  • Trend analyses for safety parameters during the trial
  • Data clarification
  • SAE narrative review
  • SAE reconciliation and coding
  • Literature evaluations (scientific, efficacy, safety and competitive analyses)


Needless to say, product safety is of the utmost importance to any healthcare company from early phase development through post-market surveillance. At R&G we have a Pharmacovigilance team specialized in the managing various safety event with vast experience in coordinating with the clinical teams, investigators and regulatory authorities to ensure swift and accurate safety reporting.

Our Pharmacovigilance Services Include:

  • Drug safety consultation
  • Pharmacovigilance project management
  • Pharmacovigilance system support
  • ICSR reporting
  • Signal detection and risk management
  • Pharmacovigilance SOP and audit
  • Literature search
  • Post marketing surveillance

If you would like to learn more about R&G, please download our brochure or feel free to contact us directly.

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