Bellafill Immunogenicity Study
Sponsor Testimonial
It was a privilege to collaborate with New Jersey Clinical Research Center (NJCRC), Dr. Barry DiBernardo, and Trial Management Consulting Group, LLC under the leadership of Claudia Jennings, who delivers exemplary professional services to research sites and sponsoring companies, ensuring full compliance with FDA guidelines.
On a 404-patient study originally projected to require three to four years from recruitment through completion, Dr. Barry DiBernardo and Claudia Jennings devised an effective strategy that expedited the timeline by three years and six months, enabling the study to be conducted within the planned 60-day timeframe.
Study participants were treated with exceptional care and respect through the study life cycle. Participant’s made comments such as “We would love to support your studies in the future due to the positive experience”, “This study was literally Efficiency on Steroids” and so much more.
Both NJCRC and TMC Group demonstrated outstanding stewardship and urgency, contributing to clinical excellence and timely delivery of study outcomes.
With support from TMC Group's professional services, the sponsor achieved IDE approval in record time and Institutional Review Board approval via an expedited process, allowing study initiation and completion in May 2025 and June-July 2025, respectively. Vendor selection and onboarding were completed within two months, with rapid database programming and go-live. The study implementation and execution proceeded smoothly through last patient/last visit (LP/LV). The sponsor representatives assigned to the Tiger study appreciated the opportunity to work under the leadership of Claudia Jennings, recognizing the valuable insights gained throughout the implementation, execution, and completion phases.
We appreciate Dr. DiBernardo and Claudia Jennings for their exceptional work and partnership.
- Pam Misajon
Suneva/Tiger Aesthetics
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