With a track record of leading 300+ RTSMs to successful go-live, Poxy Clinical is the industry’s leader in RTSM consulting, specializing in UAT Services.
Poxy Clinical is a RTSM consultancy founded in CA. In 2019, the company relocated their headquarters to renowned biotech hub Kendall Square, located in Cambridge, MA to better support the needs of a global client base.
The company’s mission began when sponsors began to reach out after experiencing major RTSM (aka ‘IRT’) issues during their clinical trials. The issues ranged from accidental unblinding, randomization errors, and mis-dosed patients – ultimately compromising patient safety. Over time, it became clear the issues were not RTSM-related, but a lack of resources and validation expertise that contributed to the oversight.
The Poxy Clinical team is comprised of experienced RTSM support leads, as well as an Advisory Board of industry leaders representing functions across Quality, Clinical Operations, Clinical Supplies, Data Management, IRT / RTSM, and Validation.
Whether your RTSM needs are UAT Services, configuration support, or market research, let Poxy Clinical’s experts help you prioritize patient safety.
CASE STUDY PROFILE 1
UAT MANAGED BY SPONSOR
A Clinical Supplies tester writes test scripts for a blinded, randomized, titration study. Study-specific negative scenarios were not tested. The RTSM was approved by the study team, and the pediatric patients began their dosing visits. All patients immediately experienced adverse effects. Upon investigating the issue, the RTSM was configured incorrectly, and the error could have been detected through negative testing. The oversight was detrimental to the study.
- Add’l RTSM vendor time and resource to repeat efforts
- Add’l sponsor time and resource to repeat UAT
- Costs for new study drug
- Data integrity compromised
- Patients were harmed
- Study timelines increased (extended recruitment, new drug shipment to sites)
SPONSOR / RTSM VENDOR RELATIONSHIP
- Sponsor and RTSM vendor trust damaged
- No further studies awarded to RTSM vendor
CASE STUDY PROFILE 2
UAT MANAGED BY POXY CLINICAL
A sponsor was challenged with minimal resources and aggressive study timelines. Poxy Clinical was contacted to support UAT services. The RTSM specs, and study protocol were closely reviewed and test scenarios were approved by the study team. During UAT, the testers were able to perform robust functional testing. Poxy helped manage issue tracking and resolution until close-out. RTSM go-live approval was completed early and the study team was satisfied.
- Study team avoids potential re-work and financial damage to correct high-risk issues
- Eliminated conflict of interest and additional costs for RTSM support
- Study timelines achieved on time
- Study teams able to focus on their clinical area of expertise
- Patient safety and data integrity is prioritized
SPONSOR / VENDOR RELATIONSHIP
- The RTSM vendor became a preferred vendor
- Positive recognition to the RTSM vendor in company-wide announcement of successful system go-live
- RTSM vendor was referred new business by study team member