Therapeutic Expertise

  • Study Coordinators Training
  • Study Nurses Training
  • Vendor Management
  • On-Site Coordination
  • Study Design & Planning
  • Protocol, CRF & ICF Development
  • Investigational Site Selection & Feasibility
  • Investigators Meetings Organization & Training
  • Patients Recruitment & Retention Strategy
  • Regulatory Strategy & Consulting
  • Project & Site Management
  • Site Monitoring & Auditing
  • Drug Safety & Pharmacovigilance Support

Medical Writing, editing and proofreading

  • Clinical Study Protocols
  • Clinical Study Reports
  • Case Report Forms
  • Patient Informed Consents
  • Abstracts for Scientific Conferences
  • Poster Presentations
  • Scientific Manuscripts Conforming to Appropriate Standards of Reporting
  • Case Report Presentations
  • Case Series
  • Assistance with Journal Selection and Online Submission
  • Medical/Scientific Literature Search & Reviews
  • Training Materials & Manuals
  • Scientific Booklets

Regulatory Affairs Services

  • Pre-submission Consulting on Regulatory Procedures & Submission Strategy
  • Evaluation of Product Submission Dossier
  • Dossier Compilation & Submission to Regulatory Authorities for Marketing Authorization
  • Post-approval Regulatory Support & Submissions (Variations, Renewals)
  • Adaptation & Translation of Product Information (SmPC, labelling & PIL) according to QRD Templates
  • Artwork Review
  • Other Regulatory Translation Services
  • Authorities Interfacing

Professional Translation Services and Desktop publishing

  • Medical/Pharmaceutical Documentation & Manuals
  • Clinical Trials Documentation & Reports
  • Journal Articles
  • Scientific Materials
  • Study Protocols
  • Product Brochures
  • Training Materials
  • Advertising Materials

EDC Solution

  • Customized EDC Platform Design, Programming and Validation
  • Web-Hosting in Dedicated Server within the European Union
  • Compliance with FDA 21 CFR Part 11 Requirements