Phase I – IV Clinical Trials


Accelerating your Clinical development programs

With an experienced team working under an accomplished Clinical Project Manager, everything is planned, implemented, and executed in line with regulatory requirements and sponsor’s expectations from onset through the entire clinical trial process.

Medical Writing

  • Protocol Synopsis
  • Protocol
  • Investigator’s Brochure
  • IMPD
  • Informed Consent Form
  • Patient Narratives
  • Clinical Study Report
  • Clinical and Nonclinical Summaries
  • Pre-Submission Preparations (e.g., pre-IND, etc.)

Regulatory Support

  • Regulatory Strategy
  • Pre-Submission Preparations (e.g., pre-IND, etc.)
  • Global Regulatory Submissions
  • IRB, Local and Central Ethical Committee Submissions
  • Regulatory Reporting

Project Management

  • Global Program Coordination and Oversight
  • Project Transition and Rescue Management
  • Vendor Mobilization and Management
  • Project Plans
  • Investigator Meetings and Training
  • DMC Support

Clinical Management and Monitoring

  • Site Feasibility and Qualification
  • Site Contracting and Payment Administration
  • Site Initiation, Monitoring and Closeout
  • Central, Remote, and Virtual Clinical Trial Monitoring
  • Risk-Based Monitoring
  • Site Audit Support

Medical Monitoring

  • Medical Support and Guidance
  • Protocol and Plans Review
  • SAE/SUSAR Review and Assessment
  • Medical and Clinical Data Review

Data Management

  • Database Build, Validation, and Testing
  • System and User Management
  • Data Cleaning and Query Management
  • Database Reconciliation and Lock
  • CDISC Standardization


  • Statistical Programming and Analysis (Tables, Listings, and Figures)
  • Adaptive Designs and Power Analyses
  • CSR, ISS/ISE, DSUR, etc. Support

Safety and Pharmacovigilance

  • Safety Database Management
  • Case Processing
  • Safety Reporting (SUSARs)
  • Medical Coding