Medical Writing • Clinical Research • Scientific Affairs

Rédaction scientifiqueRecherche cliniqueAffaires scientifiques

Regulatory Affairs

Clinical data, regulatory environment and competitive landscape assessment, and preparation of clinical documents to support regulatory approval for New Drug Submissions & Supplements. 

 

  • Due diligence 
  • Clinical overviews
  • Efficacy & safety data summaries
  • Product monographs
  • Risk Management Plans 
 

Knowledge Dissemination & Training

Content development on various topics targeting different audiences, including health care professionals, sale representatives, patients and caregivers.

 

  • Advisory Boards
  • Consultant meetings
  • Symposia
  • Continuous Health Education
  • Training materials
  • HCP, caregiver & patient tools
  • Disease prevention & management

MedStrategis can assist you in the scientific content development in four main domains: regulatory affairs, clinical research, knowledge dissemination & training, and market access.


Clinical Research

Support research teams in planning and implementing clinical study activities to collect and report scientifically sound, high-quality, and meaningful data.

 

  • Protocol development (Phase 2-4)
  • Clinical Study Reports
  • Abstracts, posters & slide kits
  • Scientific journal manuscripts
  • Systematic reviews & meta-analyses


Market Access

Development of tailored clinical dossiers highlighting product key features and place in therapy to secure product placement on private and public formularies.

 

  • Clinical summaries     
  • Clinical components      
  • Value dossiers

 

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