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Medical Affairs

R&G’s Medical Affairs Department is made of three separate functions:

  • Medical Writing
  • Medial Monitoring
  • Pharmacovigilance
  • Medical Writing

As clinical trials and regulatory procedures become more complex it is becoming increasingly more important for healthcare companies to produce well-structured documents that present information clearly and concisely. This demand for the clear articulation of medical science drives a demand for well written, standard-compliant documents that medical professionals can easily and quickly read. At R&G our Medical Writing team works closely with our Regulatory and Statistical teams to provide our clients with professional, high-quality deliverables that are compatible with ICH guidelines and all other regulatory requirements.

Our Medical Writing Services Include:

  • Clinical Trial Design, Feasibility Study and Consultation
  • Clinical Study Document Design
    • Investigator Brochure
    • Protocol
    • Patient Narratives
    • Clinical Study Report
  • Medical Information
  • Medical Translation
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:

  • Medical supervision for clinical trials (inclusion/exclusion criteria, Protocol Violation and Patient Management, Patient Safety Management, etc.)
  • Medical Coding and Medical Review of clinical data
  • 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
  • Trend analyses for safety parameters during the trial
  • Data clarification
  • SAE narrative writing and submissions to regulatory
  • 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 management clinical trial AE and SAEs 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
  • 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

Please contact us for additional information on our Medical Affairs team.

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