Drive More Successful Trial Outcomes

Leverage the latest strategies and technologies to ensure your trials run smoothly and in compliance with regulators. 

Astrix is a leading provider of Clinical and Regulatory strategic consulting & technology services, offering support tailored to meet the needs of life sciences organizations worldwide.  Our experienced teams are uniquely qualified to drive successful outcomes within this highly specialized domain, combining deep business and technology expertise to create compliant and efficient solutions that generate maximum value for your clinical trial programs.

Our Services for Regulatory Information Management

  • Strategic Consulting & Planning for Clinical & Regulatory Systems
  • Process & System Assessments and Roadmaps
  • Business Process Optimization
  • System Implementation, Optimization, and Validation
  • Change Management

End-to-End Strategic Consulting & Application Services for Your
Clinical & Regulatory Systems

We support the entire Clinical & Regulatory Lifecycle.

Clinical Development

  • Trial Management
    • Study Start-Up
    • Site Monitoring
  • Risk Based Quality Management
  • Trial Master File (TMF) Management
  • Contract Research Organization (CRO) Oversite

Regulatory Affairs

  • Registrations
  • Submission Planning & Management
  • Submission Archive
  • Health Authority (HA) Correspondence
  • Publishing
  • Identification of Medicinal Products (IDMP)

Astrix is a Veeva Vault Development Cloud Preferred Partner!

We work with clients to fundamentally improve their implementation and ongoing use of innovative technologies such as Veeva Vault.  

 
 

 

Our Work With Veeva

The Clinical & Regulatory Services practice supports Sponsor implementations with business process definition & SOP development, requirements analysis, validation, program/project management, integration and migration services in close coordination and partnership with Veeva.

Our approach is high value to our clients, as we:

  • Provide turkey solutions for our clients – bringing together people, process & technology.
  • Driving compliant and efficient business outcomes.

We provide certified implementation, development, and deployment support for:

  • Vault CTMS
  • Vault Payments
  • Vault Study Training
  • Vault eTMF
  • Vault Study Start-Up
  • Vault RIM
  • Vault Submissions
  • Vault Submissions Archive

Astrix Clinical Services

Download our brochure detailing our suite of value added services from our Clinical Services Team which include support for Veeva Vault.

LET´S GET STARTED

Contact us today and let’s begin working on a solution for your most complex strategy, technology and staffing challenges.

CONTACT US