Case Processing & Regulatory Reporting

Scalable and Flexible, end to end Pharmacovigilance Case Management Services

InteGrateTM

ICSR Integration and Process Excellence Solution

inteGrateTM is a comprehensive agile and scalable case management and analytics solution that provides pharmaceutical manufacturers and sponsors with timely, fact-based insight into the quality and timeliness of safety case processing and reporting, thereby enhancing oversight, productivity and compliance.

inteGrateTM focuses on Six Sigma and LEAN Process Excellence and includes Structured process workflows, Quality Checklists, Quality and Compliance metrics, Trend analysis and Audit readiness for global ICSR management.

The Solution supports Case Management customized integration in line with the SOPs, Literature Case management, Scientific Translations and Signal Detection.

With existing process modules, it offers Rapid Deployment with Transition and Implementation within 3 weeks and efficient case processing outsourcing costs.

Global Adverse Event Management Services

  • Data receipt, validation, archival and acknowledgment of the same to respective sponsors, thorough duplicate check before case initiation and medical assessment of seriousness.
  • Data entry done by MedDRA and WHODRL coding, entering relevant product, reporter and patient details in electronic database
  • Safety narrative writing and compilation by assessing case data and arranging various scientific factors with grammatical accuracy in a preapproved template.
  • Quality Review and assessment of the case report by highly trained experienced healthcare professionals
  • Generation of forms – CIOMS/Medwatch for cross referring. Generation and sending of follow up queries on a real time basis to sponsor or their business partners.
  • Medical review by experienced physicians who look into labeling, causality, coding, and give their medical opinion as a pharmacovigilance comment.
  • Expedited reporting done in E2B (R2/R3) format according to regulatory requirements of respective member countries and competent health authorities.
  • Extensive reconciliation of all the process and mails are done on a periodic basis, cross functionally.
  • Quality and Compliance monitoring is done by implementing various trackers and assessment methods which are shared to respective sponsor/partner on daily/weekly/monthly basis.

inteGrateTM Benefits

Rapid Deployment

Implementation and Transition within 3 weeks

Agile and Scalable

Upto 500% Scalable with process excellence

Advanced Analytics

Statistics for Process Compliance and Quality

Global Integration

Process integrations under Unified workflows

Gap Analysis

Gap Analysis and process deficiencies tracking

High Compliance and Quality

Regulatory compliance with high level of Quality Safety Data Processing

Cost Effective

Lower costs with integrated processes

Measurable Results

Clear business outcomes for KPIs/KRAs