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

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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

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