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Standardized process for every step of the way

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Clinical Operations

We Reduce Time to Market through optimization of all aspects of the clinical trial process and functional areas. We reduce risk through milestone and performance-based agreements to move your product to the next stage towards approval within budget.

 

Dataclin Clinical Operations team conducts Phases II-IV clinical trials in various therapeutic areas for pharmaceutical and biotechnology companies, maintaining the highest standards of ethics, quality and confidentiality.

For Clinical Operation, we provide the following solutions:

  • Flexible Outsource Module
    • Spanning Over the TMENA we can Provide You:
      • Flexible FTE
      • Flexible Period of Time
      • All Experience Levels
      • Managed by your Team or by DATAClin

 

  • Study Feasibilities (Country, Protocol & Site)

 

  • Regulatory Submissions through All MENA Region

 

  • Project Management
    • Dedicated Expert
    • Managing third Vendors
    • On time Reporting
    • Tracking project progress
    • Managing Change

 

  • Monitoring
    • Site Identification
    • Qualification Visits
    • Initiation Visits
    • Interim Monitoring Visits
    • Close-Out Visits

 

  • Site Management
    • Investigator Meeting Management
    • Subject Retention Strategy Enhancement
    • Regulatory Document Preparation and Collection
    • Site Personnel Training
    • Clinical Study Material Accountability
  • Medical Devices Studies
    • Full Management of Medical Device Study
    • Regulatory Documentation for;
      • Premarket Notification 510 (k)
      • Premarket Approval (PMA)
      • Investigational Device Exemption (IDE)
      • Product Development Protocol
      • Medical Device Reporting

 

  • Support for Biological & Bio-similar Studies.

 

  • Support for Genetics Studies

 

  • Support for Late-Phase Studies
    • Phase 3b
    • Phase 4
    • Drug/Disease Registries
    • Patient-Reported Outcomes (PROs)
    • Outcomes Research
    • Patient Satisfaction
    • Safety Surveillance
    • Drug Effectiveness
    • Quality of Life Issues
    • Cost-Effectiveness
    • Pharmacoepidemiology

 

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