Pharmacovigilance Experts

The definition of an expert: a person who has a special skill or knowledge in a particular field; specialist; authority.

 

The facts on our expertise:

 

  • Delivering Client Satisfaction

    • Our average performance in meeting client-specific turnaround times is 99%

    • Guaranteed delivery. Putting our money where our mouth is, we guarantee our delivery against reporting deadlines, or the case is free to you

    • “Zero Revision Rates” are our goal; our talent, our processes, and our technologies are all aligned to strive toward perfection

  • In-Depth Experience

    • PV specialists with 10+ years of experience are fully accessible and fully accountable for all portions of your project

    • Clinical experience in approximately 300 clinical trials in almost every country; currently supporting 27 countries and 45 different protocols…and counting

  • Unsurpassed Audit Performance

    • In 2008, we supported 11 clients with inspections by FDA, EMEA, or MHRA, all with positive outcomes

    • In 2009, we passed 5 of 5 audits held by current clients and were awarded 12 of 12 contracts contingent upon successful inspections

  • Streamlining Serious Adverse Event (SAE) Processes

    • Rapid query resolution time via Sentrx’s centralized SAE reporting process has reduced the average amount of follow-up by 50%

    • Unresolved inquiries have been reduced (average length of time) from several months to 5 days

  • Professional Data Migrations

    • Successfully migrated data for 15 of the top tier pharmaceutical and biotech companies over the past 10 years, migrating an estimated 60,000 records

  • Efficient Data Export

    • Unparalleled experience in mapping and moving data between various safety databases and clinical systems

Doreen Lechner, PhD

EVP Pharmacovigilance Client Services

Doreen.lechner@sentrx.com