Life Sciences Center

Life Sciences Center

Cluj-Napoca, Romania

Onsite expertise

Writing solutions

  • Clinical documents
  • Publications and medical communications
  • Advisory boards
  • Web disclosure
  • Market access
  • Regulatory affairs

Publication coordination

  • Initiation through publication managers
  • Publication of content
  • Publication coordination and workflow
  • Outline development 
  • Outline circulation for review
  • Review and incorporation of comments and new draft-creation
  • Draft quality control and circulation for review

Web disclosure

  • Protocol summary
  • Result summary
  • Obtain data
  • Write documents
  • Perform reviews and seek necessary approvals
  • Encoding
  • Quality Control and Posting

Quality Assurance Services

  • Quality Management System definition - preparation of SOPs, FORMs and GUIs
  • Computerized system validation
  • IT Infrastructure qualification
  • Change Management
  • Supplier Assessment

Training Solutions

  • Development of training materials 
  • e-Learning
  • Tailor-made training programmes with supervised learning
  • Medical and scientific writing
  • Market access 

Technologies deployed

Document Management

  • Fully confidential 
  • Microsoft SharePoint
  • Documentum
  • Datavision
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