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Medical Affairs

Crown CRO’s Medical Affairs is actively involved in our customers studies, whether from protocol writing,  a safety perspective supporting Pharmacovigilance or contributing as a Medical monitor throughout – their experience and in-house dynamic involvement helps to ensure quality and safety processes across a trials.

Cross-functional collaboration ensures smooth processes and best results

Our Medical Affairs Team also works closely with our Medical Language Services, Projects Team as well as Regulatory Affairs Team, bringing cross-functional teams together in a highly collaborative manner to help our customers achieve their goals and ensure best results.

We value diversity in education and competencies. It strengthens us in what we do

Our own in-house medics have a variety of background and experience, including the following areas:

  • Gastroenterology, Oncology, Intensive Care, Cardio Surgery, Phase I PK studies, Allergology, Clinical Immunology and Medical Device

Clinical Consultation

Clinical trials

  • Information sheets, consent forms and other texts for subjects in clinical trials
  • Protocol summaries
  • Adaptation of trial documents to meet local requirements
  • Ethics Committee documents
  • Correspondence with authorities
  • Medical records
  • Instructions for site staff

Drug Regulatory Affairs

Drug regulatory affairs

  • Summaries of Product Characteristics
  • Package Leaflets
  • Labelling
  • Training Programs for Risk Management Plans
  • Correspondence with authorities
  • Direct Healthcare Professional Communications (DHPCs)

Marketing

Marketing

  • Pharmaceutical advertisements
  • Training materials
  • Patient guides and brochures
  • Product monographs