IND Drug Safety

Our comprehensive study-level services include:

  • Develop Safety Plan and Unblinding Plan
  • Contribute to Data Quality Plan
  • Participation at Investigator Meeting / training team members on safety data reporting
  • 24 hr medical on-call / email coverage; handling of:
    • SAEs
    • Unblinding requests
    • Eligibility and other protocol conduct questions
  • Medical and scientific review of accumulating safety data
  • Presentation of safety results at DSMBs
  • Medical coding review: medical history, AEs and medications
  • Reconciliation of SAEs (per clinical and safety databases)
  • Write SAE narratives for CSR
  • Review and input on CSR
  • SAE management:
    • Develop SAE Management Plan
    • Database setup and workflow configuration per Safety Plan
    • Receive/collect SAE Worksheet reported by study sites (email, fax)
    • Data entry, review / validation
    • Queries, follow-up with study sites
    • Medical review  and prioritizing expedited reporting
    • Generate Sponsor's narrative
    • Filing safety reports with regulatory agencies

Program-level services include:

  • Development, maintenance and analysis of your Integrated Safety Database;
  • Generating IND Safety Updates, IB updates, other due diligence; and
  • NDA support: generating the Integrated Safety and Efficacy reports.

SAE Management: SAEpro

Fully configured drug safety (SAE) databases using SCiAN's SAEPRO platform are available for IND stage (phases I - III) clinical studies on a study-by-study basis or for your complete clinical development program.

The system is designed to collect, review, triage, adjudicate, and report serious adverse events (SAEs) for submission to regulatory agencies, IRBs/IECs. SAEPRO also supports integration of safety information into Investigator Brochures (IBs) and IND Safety Updates.

Key Features of SAEPRO: A Web-based Serious Adverse Event Reporting System

  • Intuitive, user-friendly interface
  • Compliant with FDA's new safety reporting requirements for IND studies (29-Sep-2010)
  • Comprehensive Help System with "Guided Data Management"
  • Proprietary "Guided Data Entry"™ system
  • Training manuals
  • User qualification module (on-line Quiz)
  • User registration and access control management module
  • Secure storage of associated source documents (emails, faxes, attachments/files)
  • Customizable workflow to match clients' business practices and SOPs
  • Auto email notification system
  • Regulatory submission tracking
  • Status reports
  • Excel database export
  • CIOMS-I and MedWATCH forms for reporting to agencies
  • Data import and export using CDISC ODM compliant XML format.