Oracle Argus E-Gateway and Empirica Upgrade & Optimization

Home / Services / Oracle Argus E-Gateway and Empirica Upgrade & Optimization

Leverage our Expertise for Continuous Change Management

Over the last 10 years, we have been helping clients to successfully adapt with changing regulations by supporting IT Change Management. Techsol has the expertise to execute periodic changes such as application upgrades, patch deployments and configurations optimization. Using best practices, we provide standard and customized Validation packages for major and minor releases for Argus Safety Suite, Empirica Suite and Gateway solutions.

Oracle Argus Safety System Upgrade and Validation

In order to have the Oracle Argus Safety system support latest combination product requirements and transition to R3, companies are expected to upgrade the Argus application to the latest 8.x version. Techsol provide an accelerated upgrade approach that enables effective management of change, shorter timelines and superior quality/compliance.

Our v8.2 upgrade accelerator has following phases:

Phase 1: System Requirements Definition and Upgrade Impact Assessment

  • Documentation of system requirements and system architecture design changes
  • Change Management risk analysis, review and mitigation
  • Detailed review of current state vs future state to understand the impact of the R3 transition on your products, data elements, reporting destination configurations etc.
  • Preparation of system upgrade project plan

Phase 2: Execution of Application Upgrade and Validation

Our accelerated upgrade include following standard tracks:

    • Track 1: Project planning, governance and tracking
    • Track 2: Business
    • Track 3: Technology
    • Track 4: Validation
    • Track 5: Training
    • Go-live and hyper care

Argus Configuration Optimization and Automation

Techsol’s Safety and Signal management process and system experts review and assess your company’s products/ licenses, global and local reporting and submission requirements, partner agreements. Our Argus Safety configuration automation solution includes assessment and optimization of various standard configurations including:

  • Auto case classification
  • Auto case routing
  • Auto listedness calculation (data sheets)
  • Auto Event seriousness assessment (IME configuration)
  • Auto Narrative and case comment generation
  • Auto distribution of SAE
  • Auto scheduling of periodic reports
  • Data validations
  • Business partner SAE reconciliation

Salient features of our Argus Configuration Optimization and Automation service:

  • Phase 1: Gap and impact assessment. Three to four weeks of expert consulting to review the company’s products/ licenses, global and local reporting/ submission requirements, partner agreements and existing configurations of the safety system.
  • Phase 2: Design and execution of configuration updates, validation and production release followed by post go-live support

News & Updates

How to Proactively Prevent Clinical Trial Protocol Deviations and Protocol Violations

Understanding the Importance of a Clinical Trial Protocol The fundamental objective of a clinical trial protocol is to provide common scientific guidance on how to conduct the clinical study in a regulatory-compliant manner and gather data that will ultimately provide answers on the safety and efficacy of the investigational medicinal product. The Guidelines for Good [...]

Food & Nutraceuticals: How Companies can Prove Health Value with Clinical Trials

What are Food and Nutraceuticals? ‘Nutraceuticals’ is a composite term of ‘nutrition’ and ‘pharmaceutical’. They are a blend of products that possess both nutritional as well as medicinal value. They are designed to improve physical health, boost immunity, and deal with stress and increase longevity. Nutraceutical products play a significant role in maintaining normal physiological [...]

Best Practices for Signal Management in Pharmacovigilance

Pharmacovigilance involves the collection, detection, assessment, and monitoring of data on Adverse Drug Reactions (ADRs) which must be evaluated to derive vital safety information. Signal detection involves monitoring the adverse reaction data for patterns that suggest new safety information. Safety signals can be detected from an extensive range of sources, such as spontaneous reports, clinical [...]

Let Us Know How We Can Help You