Clinical Trial Management Services

Zenovel offers Full-fledged Clinical Trial Management Services in India,

Medical and Scientific Writings:

  • Protocol Writing
  • Informed Consent
  • Clinical Study Reports
  • Clinical Evaluation Reports
  • Investigator’s Brochure
  • IMPD
  • Patient Narratives
  • Clinical and Nonclinical Summaries
  • Pre-Submission Preparations

Regulatory Approval Support:

  • Protocol Writing
  • Informed Consent
  • Clinical Study Reports
  • Clinical Evaluation Reports
  • Investigator’s Brochure
  • IMPD
  • Patient Narratives
  • Clinical and Nonclinical Summaries
  • Pre-Submission Preparations

Project Management:

  • Project Planning
  • Coordination and Oversight Management
  • Investigator Meeting Management
  • Training Management
  • Primary liaison with sponsor, site, and team

Trial Monitoring and Management:

  • Site Identification, Feasibility and Qualification
  • Liaising and Contracting with sites
  • Risk-Based Monitoring: Site Initiation, IMV and Closeout
  • Central, Remote, and Virtual Trial Monitoring
  • Site Audit

Data Management:

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

PK Statistics:

  • Adaptive Trial Designs
  • Power Analyses
  • Statistical Programming and Analysis
  • CSR, ISS/ISE, DSUR

We are happy to help. Reach us at: +91-635-635-3636 , bd@zenovel.com

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