Clinical Pharmacovigilance Services

Delivering Safety throughout the Product Life Cycle

OUR TEAM OF EXPERIENCED SUBJECT MATTER EXPERTS CAN SUPPORT YOUR CLINICAL PHARMACOVIGILANCE NEEDS

Our team of experienced Pharmacovigilance (PV) subject matter experts, can assist your organization in effectively monitoring the safety of your investigational product, navigating the demanding regulatory landscape, and providing an End-to-End Clinical Pharmacovigilance Service that supports you at all stages throughout the product life cycle. Our Clinical Pharmacovigilance Services are also available as flexible single-service solutions based on your organization’s needs.

Image
Image

ARE YOU LOOKING TO OUTSOURCE YOUR CLINICAL PHARMACOVIGILANCE?

At Navitas Life Sciences, our Clinical Safety processes have been specifically designed to meet all local safety requirements. We provide our clients with customizable, flexible, and cost-effective full-service solutions, adopting a follow the sun model to increase responsiveness and reduce delays, further supported by best-in-class technologies. Our End-to-End Clinical Pharmacovigilance Services include:

Clinical PV Project Management

We can provide full service Clinical PV Project Management

  • Adopting a risk-based approach, utilizing Quality Management Systems (QMS) and Information Security Management Systems (ISMSs) we ensure risk identification and mitigation
  • Transparent Governance structure with immediate escalation path
  • 24/7 troubleshooting availability
  • Agreed Service Level Agreements and Turnaround Times (TATs) with supporting Quality Monitoring
  • Regular Safety Status Review meetings with stakeholders
Safety Submissions

We can support your Safety Submissions

  • Expedited reporting of individual cases to National Competent Authorities (NCAs), Institutional Review Boards (IRBs) or Ethics Committees (ECs), and Investigators
  • Pharmacovigilance report submissions performed through HA gateways, web portals, emails, fax, and provision of manual submission by local PV Responsible Person for applicable countries
  • Set up of gateway connection(s) with main NCAs

ADVANTAGE OF OUTSOURCING YOUR CLINICAL PHARMACOVIGILANCE REQUIREMENTS TO NAVITAS LIFE SCIENCES

Experienced Global Team with Optimal Infrastructure

Experienced Global Team with Optimal Infrastructure

PV Domain Experts

PV Domain
Experts

Cost Effective and Efficient Support

Cost Effective and Efficient Support

Ability to Scale to Suit Specific PV Needs

Ability to Scale to Suit Specific PV Needs

Customizable Approaches

Customizable Approaches

Patient Centric Outcomes

Patient Centric Outcomes

“Navitas Life Sciences are always willing to meet our needs. It is a true collaboration and a very good partnership. We are extremely happy with their performance. All deliverables have been provided on time with clear communication and prompt updates.”

Learn how we have achieved complete Inspection Readiness in PV operations for a mid-sized North American pharmaceutical company

Effective Processes, Best in Class Technology, and Global End-to-End PV Services