Pharmacovigilance

Pharmacovigilance

The complexities involved in regulatory safety reporting necessitates proficiency to ensure quick access to intelligent data. The capture and analysis of safety data are critical in clinical trial management, as trials ultimately must demonstrate safety as well as efficacy.

PureSoftware provides Pharmacovigilance services that allow long-term success. Our consultants address the issues related to drug safety and process consistency, like the new compliance requirements, and can integrate safety data from dissimilar sources.

We provide professional services on the Argus product in the following areas:

  • Install, config and upgrades
  • MedDRA dictionary updates
  • System validation – IQ, OQ, PQ
  • Regulatory / GCP validation
  • RPA and AI solutions and accelerator implementations

Our Capabilities across the Pharmacovigilance Lifecycle

AE Collection
and Follow-up

Case Entry
and Processing

Monitoring
and Analysis

Reports Generation and Customization

Proactive PV & E

Life Sciences Services & Solutions

Clinical Data
Collection

PureSoftware understands that the quality and integrity of the data are of primary importance.

Clinical Data
Management

Clinical Data Management is a critical phase in clinical research, and data integrity is of paramount importance.

Application Management
Services (AMS)

PureSoftware provides AMS and helps companies remove barriers to solution adoption.

Infrastructure Management
Services

PureSoftware offers a spectrum of integrating applications and infrastructure services tailored to meet client-specific needs.

Our Digital Capabilities for Life Sciences

We value partnering with life sciences organizations and develop technology-based solutions for them.

Why Choose PureSoftware?

  • Enhanced operational efficiencies which can be measured through metrics.
  • Realizable productivity enhancement through improved processes, and significant cost benefits.
  • Data Management (CDM) & Biostatistics Team working together for better synergies.
  • Full transparency in dealing and robust governance

We have some of the World’s Best Life Science Organizations relying on us.
You can become the next one.