Make Data Integrity and Patient Safety a Priority

We will help you develop a custom, risk-based approach to confidently validate your RTSM supported clinical trials.

In the highly regulated life sciences industry, sponsors are often challenged when they do not have the resources or expertise to manage user acceptance testing (UAT). High-risk areas can be missed – impacting time, cost, sponsor-vendor relationships, data integrity and most importantly, patient safety.

 

The success of your clinical trials matter to us as much as they do to you.  Let us help you confidently validate your Randomization and Trial Supply Management (RTSM) software is ‘fit-for-purpose.’

“Testing at the user site is an essential part of software validation.”

US FOOD AND DRUG ADMINISTRATION (FDA)

OUR SERVICES SUPPORT:

CLINICAL TRIALS

We focus on high-risk areas, vetting RTSM (Randomization & Trial Supply Management) functionality during UAT before it impacts patient safety during the clinical trial.

VALIDATION

We incorporate industry and software validation best practices and fully document your UAT with an inspection-ready report.

COLLABORATION

We remove conflict of interest between the Sponsor and RTSM vendors by developing  a customized test strategy that promotes team collaboration.

PRODUCTIVITY

We enable study teams to focus on their expertise and help increase productivity by removing the burden of UAT management.

WHAT PEOPLE ARE SAYING:

Poxy Clinical’s mission is to support innovative clinical trial technology while keeping data integrity, and patient safety a priority. We are deeply committed to providing quality services to sponsors in their journey to develop vital medicines. See what some of our happy customers are saying:

  • After we encountered an MHRA finding from a past UAT, we decided to approach UAT more seriously. We were challenged with a geographically spread team. After a few UATs with Poxy Clinical, we had a very positive experience which carried over to company-wide process improvement opportunities.
    Clinical Supplies Assoc. Director

    Biotech HQ in Japan

  • Poxy Clinical has been an immense help to me and the study team. Their expertise, organizational skills, and support gave me confidence that our RTSM was set-up correctly to provide treatment to our study subjects in the U.S. and internationally. I could not have done it on my own, and am so grateful for Poxy Clinical!
    Clinical Trial Manager

    Oncology Biotech

  • The UAT processes were set-up very nicely and much better than prior experiences I have had elsewhere. I appreciate Poxy's testcases and organization. It made UAT much more streamlined and easier!
    Biostatics Director

    Infectious Disease Biotech

  • Poxy Clinical demonstrated our RTSM knowledge, and made our coordination efforts easier. They fully managed the issues log and their ability to support test case and system-related issues helped streamline the process for us.
    Client Support Role

    RTSM Vendor

  • UAT data set-up varies from Sponsor to Sponsor which can be challenging for us. Often data requirements are not communicated upfront. Working with Poxy Clinical made this process painless, and they provided adequate lead time, which enabled complete UAT preparation early, which made our Sponsor very happy.
    Client Support Role

    RTSM Vendor

  • The Poxy Clinical team has a very clear understanding of IRT systems as well as quality/validation best practices. Their help was instrumental in helping us make sure the IRT UAT for my study went smoothly. It would be a pleasure to work with Poxy Clinical again!
    Clinical Data Manager

    Global Oncology Biotech

  • After we encountered an MHRA finding from a past UAT, we decided to approach UAT more seriously. We were challenged with a geographically spread team. After a few UATs with Poxy Clinical, we had a very positive experience which carried over to company-wide process improvement opportunities.
    Clinical Supplies Assoc. Director

    Biotech HQ in Japan

  • Poxy Clinical has been an immense help to me and the study team. Their expertise, organizational skills, and support gave me confidence that our RTSM was set-up correctly to provide treatment to our study subjects in the U.S. and internationally. I could not have done it on my own, and am so grateful for Poxy Clinical!
    Clinical Trial Manager

    Oncology Biotech

  • The UAT processes were set-up very nicely and much better than prior experiences I have had elsewhere. I appreciate Poxy's testcases and organization. It made UAT much more streamlined and easier!
    Biostatics Director

    Infectious Disease Biotech

  • Poxy Clinical demonstrated our RTSM knowledge, and made our coordination efforts easier. They fully managed the issues log and their ability to support test case and system-related issues helped streamline the process for us.
    Client Support Role

    RTSM Vendor

  • UAT data set-up varies from Sponsor to Sponsor which can be challenging for us. Often data requirements are not communicated upfront. Working with Poxy Clinical made this process painless, and they provided adequate lead time, which enabled complete UAT preparation early, which made our Sponsor very happy.
    Client Support Role

    RTSM Vendor

  • The Poxy Clinical team has a very clear understanding of IRT systems as well as quality/validation best practices. Their help was instrumental in helping us make sure the IRT UAT for my study went smoothly. It would be a pleasure to work with Poxy Clinical again!
    Clinical Data Manager

    Global Oncology Biotech