Successful Pharma organizations are forward-thinking – they improve their process now, not after a failed project. Our clients view Pharmacovigilance as a strategic function of their company.

Avoid project failure with a pharma project plan. Put in place a plan for risk management, signal detection and signal management with the help of consultants who understand the pharmaceutical life cycle.

Pharma Project Planning

Discussion Consultant ChicagoPharmacovigilance projects are complex and require effective project management.

There are many departments involved, often operating in silos, therefore they aren’t able to communicate very effectively and efforts are often duplicated. Additionally, organizations can have multiple locations, each with their own set of processes in use. All of these barriers need to be broken to allow for complete harmonization across all of the departments.

Tell us about your Pharmacovigilance needs


Improve Your Process

It is no longer “OK” to be compliant with case processing alone. You need to be thinking strategically about Pharmacovigilance, which means thinking about all of these pieces and how they intersect.

  • Adverse Event Case Processing
  • Signal Detection & Signal Management
  • Advanced Pharmacovigilance
  • Risk Management
  • PASS/PAES
  • Benefit/Risk
  • Outsourcing Activities

Become a Global Pharmacovigilance Organization

We can help you transition from country-centric operations to a global organization by:

  • Facilitating the implementation of Adverse Event case processing and Signal Management systems
  • Performing current state assessments and future state designs for case processing
  • Helping organizations outsource their case processing activities, and developing training materials for the end users who will be performing those activities
  • Educating management on the implications of PASS and PAES.
  • Standardizing your processes and procedures for compiling and maintaining your PSMF
  • Developing a program for implementation of benefit/risk methodology

We have been working with Pharmacovigilance organizations for years, so we know the regulations and understand the process. We recognize how much effort is takes to become a forward-thinking Pharmacovigilance organization, and we’re here to support your transformation.

Let’s talk about your Drug Safety goals