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Medical Affairs

ZEINCRO offers a variety of services to enable customers to meet their overall medical affairs needs, including medical writing, medical monitoring, risk and strategic planning, and safety oversight.


We provide a full range of medical services for scientific communications and medico-marketing material as well as for regulatory submissions, across diverse therapeutic areas. We are committed to deliver high-quality documents, on time and on budget. These services can be offered on a stand-alone basis or as an integrated part of a clinical development program or study.


Our Medical Affairs team works closely with local and international Key Opinion Leaders and with our pivotal operational departments, such as Clinical Operations for both Late Phase studies and Early Phase interventional trials, Regulatory Affairs, Data Management, and Pharmacovigilance to deliver accurate and effective documents to the highest standards.


Our highly flexible and customer-centric approach ensures our clients to have a regular communication during the course of the project and to get responses to their expectations.

 

SERVICES

MEDICAL WRITING

  • Study design (all phases, including Adaptive design)
  • Protocol and Amendment
  • Case Report Form (CRF)
  • Informed Consent Form (ICF)
  • Paediatric Assent Form
  • Clinical Study Report (CSR)
  • Patient Safety Narratives
  • Investigator’s Brochure (IB)
  • Patient Information Leaflet
  • Educational Material for patients, healthcare professionals, and pharmaceutical company personnel
  • Patient Support Program design and supervision
  • Early Access Program consulting (NPP and Cohort)
  • Biowaiver Application document
  • Expert Report
  • Added Value Dossier
  • Scientific Article, Poster, and Presentation
  • Toxicology and Permitted Daily Exposure (PDE) report
  • Clinical Evaluation (CER) and Trend Report for medical devices
  • Readability Study
  • Usability Study
  • Time and Motion Study

 

MEDICAL MONITORING

  • Medical review/advisory on study aspects and conduct
  • Medical assessment of Adverse Event reports for Pharmacovigilance
  • Medical review of Development Safety Update Report (DSUR) and Periodic Safety Update Report (PSUR)
  • Medical input to the development and review of Risk Management Plan (RMP) and Signal Management
  • Benefit-risk assessment of medicinal products and devices


FEASIBILITY

  • Protocol review and guidance
  • Contact with key opinion leaders requiring study specifications
  • Provision of epidemiological and scientific data
  • Feasibility questionnaire/survey development and review


TRAINING

  • Therapeutic area
  • Medical Advisor course
  • Study design and conduct
  • Study document overview


MARKET RESEARCH AND STRATEGIC PLANNING

  • Therapeutic area questionnaires
  • Content of discussion of Focus Groups & Advisory Boards
  • Collaboration with Sponsor’s Medical and Market Development departments
  • Medical web/mobile application design

MEDICAL SUPPORT

  • Client-tailored advisory, review, and design of scientific documents, queries, and activities
  • Literature review
  • Functional Service Provision of Medical personnel

 

Interest Form

  • Interested for more information?

     
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  • Interventional Trials - Phase I - IV
    Non Interventional Trials - Post Authorization Safety and Efficacy Studies
    Regulatory Affairs
    Pharmacovigilance
    Medical Affairs
    Other
     
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  • We respect your privacy. We will not share, lease or sell your contact information. Please read our Data Privacy Policy.

     
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ABOUT US

ZEINCRO is a leading contract research organization covering more than 21 countries in Europe, with a special focus in the region of Central and South Eastern Europe (Albania, Austria, Bulgaria, Cyprus, Czech Republic, Germany, Estonia, FYROM, Greece, Hungary, Latvia, Lithuania, Malta, Moldova, the Netherlands, Poland, Romania, Slovakia, Switzerland, Turkey and Ukraine).

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CONTACT US

  • Email:  info@zeincro.com

ZEINCRO : member of

European CRO Federation (EUCROF)

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