Clinical Trial Services:

 

Clinical Development:

  • Develop clinical trial protocols and/or investigational plans

  • ICF Development with local language translations, 

  • SOPs and WI development

  • Case Report Forms for Paper And EDC studies

  • Investigator Brochures

  • Essential Documents

 

Investigator /Site Management:

  • Liaison between investigational sites, and CROs

  • Project Management Activities

  • Ethics Committee Management

  • Monitor Activities

  • Site Coordination for data collection and query management

Case Study Report (Clinical Study Report) Services:

  • Conduct basic statistical analyses for technical support of molecule.

  • Generate clinical study reports.

  • Conduct literature reviews.

  • Evaluate and report on adverse events associated with the molecule.

 

Clinical Trial Project Management:

  • Manage site feasibility, recruitment/selection

  • Conduct investigator meeting

  • Management of clinical study site.

  • Ethics Committee Submissions

  • Oversee project budgets, budget change forms, accruals, and monthly reports

For more information email us at info@pharexcelconsulting.com or contact us today.

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