From study design to execution

Clinical Research

Study design

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• Synopsis Development
• Sample Size Stat Power
• Protocol Writing
• Statistical Section of Protocol
• Clinical Development Plan
• Feasibility Studies

Project management

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• Oversight
• Patient Identification / Sourcing
• Vendor Selection
• Investigators Fees Management
• Patient Fees Management
• Coordination & Communication
• DSMB - Experts Board Management

Regulatory affairs

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• CTA Application
• IMPD
• CMC
• PIP
• IND
• Scientific Advice
• Briefing Book

Regulatory submission

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• Gap Analysis
• Coordination with Local Authorities
• Documents Review and Preparation
• Protocol Review and Translation
• Submission and Follow Up

Clinical operations

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• Trainings
• Site Qualifications Visits
• Site Initiation Visits
• Monitoring Visits
• Close Out Visits
• CRAs Management & Coordination
• Recruitment & Direct-to-Patient

Data management

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• CRF Design
• Data Management Plan
• DataBase Set Up
• Data Cleaning
• eCRF
• ePRO
• DataBase Lock
• Medical Review

Biostatistics

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• SAP
• TFLs Generation
• Statistical Review of TFLs
• Stat Report
• Submission Package

Medical writing

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• Narrative Drafting & Review
• Clinical Study Report
• Publication

Study design

Synopsis Development Sample Size Stat Power Protocol Writing Statistical Section of Protocol Clinical Development Plan Feasibility Studies

Project management

  • Synopsis Development
  • Sample Size Stat Power
  • Protocol Writing
  • Statistical Section of Protocol
  • Clinical Development Plan
  • Feasibility Studies

Study Design

  • Synopsis Development
  • Sample Size Stat Power
  • Protocol Writing
  • Statistical Section of Protocol
  • Clinical Development Plan
  • Feasibility Studies

Study Design

  • Synopsis Development
  • Sample Size Stat Power
  • Protocol Writing
  • Statistical Section of Protocol
  • Clinical Development Plan
  • Feasibility Studies