PMCF STUDY

ECLEVAR provides professional report writing and manuscript submission services to medical device manufacturers. We employ physicians and scientific experts who have contributed in part, or in whole, to clinical reports for regulatory submissions and academic journals. Together with colleagues in our biostatistical, clinical, and regulatory groups, our medical writing services providers organize, interpret, and present data in the most accurate and professional manner possible.

  • Interim and final clinical reports
  • Sections of interim and final clinical reports
  • Co-authorship to journal submissions
  • Literature summaries
  • Expert opinion letters
  • Review and editing
  • Regulatory submissions
  • Advisory panel presentations
Our Clinical Operations team is highly skilled and experienced in project management, site management, monitoring, and safety management. Furthermore, our multi-lingual clinical staff trained in ICH GCP and EN ISO 14155 are based all across the EU. We have a proven track record of successful audits by FDA and various EU Member State Competent Authorities.
 
From regulatory submissions to site close-out we process in full compliance with EN ISO 14155, EN ISO 13485, 21 CFR Part 820 which include :
  • Site Selection and Qualification. 
  • Site Initiation (SIVs) and Support Visits/Staff Training. 
  • Site Management and Monitoring by local ECLEVAR CRAs with native language ability.
  • Clinical Project Management. 
  • Safety Management and Reporting.
  • CEC/DSMB Set-up and management. 
  • Writing of Clinical Study Reports.

Are ECLEVAR‘s services a good fit for your needs ?

Contact a ECLEVAR representative +33 1 45 01 61 60 or through our site contact form

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EU ISSUES Q&A DOCUMENT TO PROVIDE FURTHER ANALYSIS OF POTENTIAL NO-DEAL BREXIT

Twelve (12) months ago, the EU Commission published a Notice to Stakeholders, “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products,”Read More..

JOIN ECLEVAR AT MEDTEC JAPAN

ECLEVAR invites you to meet with us at MedTec Japan in Tokyo, Japan on 18-20 April.