On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management.

Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

https://www.bmj.com/content/375/bmj.n2635

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial BMJ 2021;375:n2635; https://www.bmj.com/content/375/bmj.n2635

Study to Evaluate the Safety and Efficacy of a Booster Dose of BNT162b2 Against COVID-19 in Participants ≥16 Years of Age https://clinicaltrials.gov/ct2/show/NCT04955626

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children and Young Adults https://clinicaltrials.gov/ct2/show/NCT04816643

Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS CoV-2 RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older https://clinicaltrials.gov/ct2/show/NCT04754594