Pharmacovigilance Automation

Leveraging data-centric emerging technologies
to achieve greater efficiency

OUR TEAM OF EXPERIENCED PROFESSIONALS CAN SUPPORT YOUR PV AUTOMATION NEEDS

The environment in which life sciences companies are operating is changing at an alarmingly fast rate. With lower investments to bring out new drugs and a shorter time to market them, we are witnessing a response of maturing IT systems, digital trends, and drivers that are shaping the future and creating opportunities to further transform PV. This doesn’t come without its challenges with both validation and capacity remaining something of a barrier, coupled with unclear expectations from regulators. At Navitas Life Sciences, we have the required skillset and experience to leverage data-centric merging technologies that support your PV automation requirements, using a combination of internal and external tools we can help you to achieve a full automation experience, realizing greater efficiencies and ensuring proactive PV.

Image

ICSR is the main focus of
PV Automation

According to the 2020 benchmark reports from our industry leading networks, pvnet® and pvconnect®, ICSR remains the main area of focus for PV Automation with some 86% of large and 48% of Small-Medium companies automating the process.

According to the reports, other areas of interest for automation include:

  • Aggregate Reporting
  • Signal Management
  • Risk Management

HOW NAVITAS LIFE SCIENCES CAN SUPPORT YOUR PV AUTOMATION INITIATIVE

With NextGen PV requiring a multi-faceted approach, we understand the required building blocks to deliver a transformational PV automation project to digitize the future. Drawing on our 30+ years of PV experience, we can support you to implement Artificial Intelligence (AI) and Machine Learning (ML) driven technologies, that transform PV activities and deliver greater efficiencies.
Image
Image
We have been working in partnership with Oracle Health Sciences for 10+ years, helping to simplify the technology landscape and enable better outcomes for our clients.

Learn how we successfully leveraged automation for expedited end-to-end ICSR processing and submissions

Our PV Automation services include

PV Automation Strategy

PV Automation Strategy

We can build a PV Automation Strategy to support a digitalized future

  • Exploring industry trends
  • Identifying automation opportunities
  • Defining a high level solution(s) to include data sources, process steps, and tools
  • Developing a plan for implementation to include:
    • A business case
    • Realization of TOI
    • A change management approach
Technology Implementation and Change Management

Technology Implementation and Change Management

We can implement leading edge technology reinforced with Change Management plans

  • Developing data transformation routines
  • Building and extracting ML data
  • Reconfiguring the Safety Database to enable process automation
  • Validation – to include dry-runs and pilots
  • Managing change, Standard Operating Procedures (SOPs), and Web Intelligence
  • Training support
Support and Maintenance

Support and Maintenance

We provide ongoing Support and Maintenance

  • Supporting users to address issues and queries
  • Supporting vendor management
  • Monitoring the application
  • Planning for additional MLcycles and/or verifications
  • Planning for changes and/or upgrades

ADVANTAGE OF OUTSOURCING YOUR PV AUTOMATION REQUIREMENTS TO NAVITAS LIFE SCIENCES

Invest in Key Capabilities

Invest in Key Capabilities

  • Digital technology
  • Data and analytics
  • Source and upskill talent
Foster the Right Culture

Foster the Right Culture

  • Innovation
  • Agility
  • Data centricity
Forge Partnerships

Forge Partnerships

  • Internally across the enterprise
  • Industry: Vendors, Regulators, and Academia
  • Influence with mutual benefit
Demonstrate Value

Demonstrate Value

  • Start small and build
  • Deliver ROI
  • Sustain the gains