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AccelSafety

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Integrated Drug Safety and Signal Management Solution For Biopharma and CROs

‘AccelSafety’ is a comprehensive pharmacovigilance platform of Techsol built around Oracle Argus Safety application to address business needs of unified collection, medical assessment and regulatory reporting of clinical & post-marketing safety surveillance data.

Our fully-managed cloud solution facilitates emerging biopharma, device manufacturers and service providers to manage safety data and take informed business decisions in alignment to global compliance requirements.

AccelSafety Solution Models

We have been a trusted Oracle Gold partner for the last 8 years and have successfully delivered over 100+ projects across 5 continents.

With AccelSafety, clients can choose one of the below solution model which can meet their business needs.

AccelSafety Standard

For core Drug Safety operations and e-submissions

AccelSafety Enterprise

Standard plus Advanced Analytics and Datamart options

AccelSafety Premium

Includes Enterprise plus Oracle Empirica Signal & Topics

AccelSafety Japan

Core Module with Add-on for integrated Japanese operations

What do we offer clients with AccelSafety?

Specialized Argus Safety Configurations Setup

Our Argus certified SMEs offer extensive technical and functional guidance to configure:

  • Products, Studies and associated workflows
  • Auto-narratives and letter generation
  • Global Reporting Rules
  • Optimized Business Rules for lean workflows
  • Dictionary Management (MedDRA English & Japan, WHO Drug)
  • Users & Roles Administration
  • Query & Reporting Services
  • Signal Management

Setup Regulatory Reports and Configurations

Based on your global compliance requirements, we can setup and automate the schedule for generating the following regulatory related reports:

  • ICH: E2B R3 electronic data submission
  • ICH: E2C periodic safety update report (PSUR)
  • ICH clinical trial periodic report and EUSAR
  • IND and NDA periodic report
  • CIOMS II line listing and CIOMS V
  • EMEA/CPMP reporting

Drug Safety Business Process Definition

Based on your requirements, we can offer functional domain expertise for:

  • Business Process Design for end-to-end Case Management
  • Setup of Signal Management Module
  • Configuration of process specific compliance reports and productivity dashboards
  • Support for reports generation in E2B (R3) & E2B (R2) formats
  • Argus DLP integrated safety case summaries
  • Validating Argus Safety for 21 CFR Part 11 Compliance

Facilitate Electronic Submissions to Global Regulatory Bodies

As a trusted partner of Oracle and Axway, we can enable the complete automation of your electronic submissions of safety case data information to Regulatory agencies and your business partners. We have tailored process based on our working experience in setting up and pilot testing with below Regulatory agencies:

  • FDA, EMA ( and the associated NCA)
  • PMDA, Health Canada
  • MHRA

How Do we Deliver

AccelSafety is delivered on a GxP compliant fully-managed cloud platform hosted on Amazon Web Services (AWS) which has security and quality certifications such as ISO 9001, ISO 27001, ISO 27017 and ISO 27018.

All ongoing systems validation and preventive maintenance of Oracle Argus Safety and associated add-on applications will be managed by Techsol throughout the business lifecycle.

Why ‘AccelSafety’ is an ideal choice for Clients?

  • Techsol owns the responsibility for the end-to-end management of Argus Safety application
  • Burden of validation & compliance management is significantly reduced
  • Security option with Single sign-on is available
  • Includes all future application version upgrades, dictionary upgrades, and security updates
  • Considerably reduces Total Cost of Ownership (TCO)

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