As a trusted Oracle Partner, Techsol has vast experience in delivering Oracle’s comprehensive suite of Safety and Signal management applications to global clients. Since 2010, we have worked extensively with all the Oracle Argus Safety Global modules (Standard and Enterprise Editions), Oracle B2B and Axway E2B E-Submission Gateways, Oracle Empirica Signal & Topics and successfully completed several system implementation, validation and application version upgrade projects.
With a team of certified Argus Safety Consultants, our credentials are recognized and recommended by Oracle as one of the most-preferred strategic partners. Today, we work closely with Oracle to execute systems implementation and validation projects for clients who choose to use the Oracle Argus Safety Cloud platform.
Our Safety System Technology Consulting Capability
10
+ Years of Drug Safety Technology Experience
110
+ System Implementation and Upgrade Projects
50
Case Data and Systems Migration Projects
60
e-Submission Gateway Setup (FDA, EMEA etc.)
What We Can Do
How Do We Deliver
With our extensive experience, we have aligned our implementation methodology and validation services to the GAMP5 Risk-based methodology. Our team can provide consulting guidance to your organization from the initial system requirements definition to post-launch and hypercare.
Our specialized validation services for Techsol’s AccelSafety Cloud or Oracle Argus Safety Cloud with the e-Submission Gateway and Oracle Empirica Signal includes:
- Requirement assessment and authoring
- Validation protocol development and Risk assessment
- Assessment and strategic support on Signal management requirements
- Setup of workflow in compliance with GVP module IX of EMA
- Development and execution of validation plan and report deliverables including
- Validation Master plan
- Risk Management plan
- OQ and PQ/ UAT script authoring and execution/ support
- Traceability matrix and closure report
- Implementation and pilot test deliverables for gateway applications such as Axway B2B and Oracle B2B
- E-Submission Gateway pilot testing with all of the global agencies such as FDA, EU, PMDA, Health Canada etc.
- End user and administration training
- Project management
Additional Value-Add Services We offer to Clients on Techsol’s AccelSafety Cloud or Oracle Argus Safety Cloud
- Data and systems migration qualification
- Application and Configurations Upgrade and Optimization
- System Integration build, test and deployment
- Custom Reports and Dashboards development
- Post go-live application and change management support
Thought Leadership
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 [...]