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Our Services

Clinical Development Planning and Execution

  • 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
  • On-Site Study Coordination

State-of-the-Art Electronic Data Capture (EDC) Solutions

  • Customized EDC Platform Design, Programming and Validation
  • Web-Hosting in Dedicated Server within the European Union
  • 24/7 Help-Desk Support
  • Compliance with FDA 21 CFR Part 11 Requirements

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

Customized Training Workshops & Seminars

  • Planning, Development & Delivery of Pharmaceutical / Healthcare-related Training
  • Investigational Site Personnel Clinical Research Training
  • CRA Training Courses
  • Training on Good Clinical Practices Procedures
  • Training on Local/International Clinical Research Regulations & Legislation
  • Training on Good Medical Writing Practices

Quality Assurance

  • GCP Site Audits
  • Process Evaluation Audits
  • Site Preparation for Regulatory Authority Agency Inspections
  • GCP Education, Training Program Development & Presentations
  • Standard Operating Procedures Development

Biometrics

Data Management
  • Database Design, Development & Programming
  • CRF annotation &Manual Data Handling
  • Data Management &Validation Planning
  • Dictionary Processing & Medical Coding
  • Single & Double Data Entry
  • Medical Data Coding by Certified Coders
  • Data Quality Review and Data Validation/Cleaning
  • Adverse Event Reconciliation

Biostatistics
  • Sample Size/Power Determination
  • Randomization Schedule
  • Statistical Input for Clinical Study Protocols
  • Statistical Programming
  • Statistical Analysis Plan Preparation
  • Statistical Tables, Figures and Listings
  • Statistical Analysis Report Preparation
  • Creation of CDISC Compliant Databases (e.g. SDTM, ADAM)

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

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

Pharmacovigilance Services

  • Provision of QPPV and 24/7 Safety Contact Person Services
  • Registration of Sponsor and of Trial IMPs in Eudravigilance
  • Development of CT-specific Supportive Documentation Related to Safety Reporting
  • Safety Reporting in Eudravigilance and Submissions to the Authorities
  • Preparation and Submission of Development Safety Update Reports
  • Pharmacovigilance Training

Resourcing and Recruiting Services to the biopharmaceutical and medical devices industries

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