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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)

Pharmacovigilance

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 management clinical trial SAE and ADR with vast experience coordinating with the clinical teams, Investigators and regulatory authorities to ensure swift and accurate reporting.

Our Pharmacovigilance Services Include:

  • Pharmacovigilance Strategy and Consultation
  • Pharmacovigilance Management Plan Development
  • Serious Adverse Event Report Form Design and Annotation
  • Serious Adverse Event and Adverse Drug Reaction Reporting and Management
  • Pharmacovigilance Related SOP Development and Auditing
  • Organization and Operation of Drug Safety Monitoring Committee
  • Drug Safety Database Set-up and Maintenance
  • Drug Safety Daily Monitoring and Signal Evaluation
  • Drug Benefit-risk Assessment
  • Drug Safety Literature Search

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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