About

Universal Axon Clinical Research (UACR) is a Clinical Research Facility Organization, with the experience and history of providing quality services to Sponsors/CROs. UACR was the result of a merger between Universal Clinical Research Associates, Inc. (a clinical and device research site with 12 years of experience) and Axon Human, LLC (a physician management organization), together the entities combine the expert knowledge to conduct successful clinical trials as well as a vast network of physicians in multiple therapeutic areas. UACR provides the clinical research industry with an enthusiastic clinical research site, providing a service to patients and the Pharmaceutical Industry, in compliance with Good Clinical Practices/ ICH Guidelines.

UACR specializes in working with physicians who are well established in their respective fields of practice, and who are interested in transitioning into the clinical research arena as Principal Investigators/ Sub-Investigators. UACR is committed to providing a new pool of highly qualified Principal Investigators with under-represented patient populations. Our goal is to increase the inclusion of representation in clinical studies for all indications, by focusing on those physicians with a high percentage of a specific patient population in their database, as requested by Sponsors/ CROs.

UACR provides the needed ICH/ GCP training, in addition to extensive training, full-scale site management support and a one-on-one working relationship for our physicians and staff, who remain an integral part of our organization.

Training:
UACR requires all Principal Investigators, Sub-Investigators and Study staff, to complete an extensive program, which focuses on GCP regulations and guidelines, physician and staff responsibilities and the overall day to day operations required to effectively run an investigative site and conduct outstanding clinical research.
The training program may be conducted by an in-house personnel or outside consulting firm, who would provide in-depth and comprehensive on-site training for UACR employees. The required training components are complete; and the program is flexible enough to focus on additional areas that are of specific interest for our site. UACR will continue to update all Study staff with continuous training in regards to updates to industry regulations and standards.
UACR Study staff will have appropriate documentation regarding completion of training modules.   Additionally, templates for maintaining training records for each staff member will be provided.
Site Management:
UACR provides the following:

  • Assignment of a dedicated Clinical Research Project Manager/ Director to oversee the clinical operations.
  • Marketing and business development of UACR and its capabilities for all upcoming research trials and opportunities
  • Complete Study feasibility questionnaires
  • Budget Negotiations with Sponsor/CROs
  • Incorporating UACR specific S tandard O perating P rocedures (SOP’s) and/ or incorporating/ utilizing only, Sponsor’s SOPs
  • Study start-up activities to include collecting and processing regulatory documentation.
  • Subject recruitment strategies
  • CRF Completion and Query Management
  • Conducting on-site independent QA protocol audits for QA, sponsors and FDA inspection preparation and training purposes

Physicians:
Our network of highly qualified and enthusiastic-clinical investigators would provide Sponsors/CROs demand with the highly capable and qualified Investigators. UACR ‘s Investigators encompass those criteria. Below are some minimal requirements for our Investigators:

  • UACR PI/ Sub-I will provide a copy of current CV and medical license.
  • UACR PI/ Sub-I will not have been debarred or currently under investigation by FDA or any medical licensure board or have any limitations placed on his/her ability to practice medicine.
  • UACR PI/ Sub-I understands his/ her role and responsibilities of a PI/ Sub-I and is willing to undertake such responsibilities (provided by UACR); as well as a working knowledge of ICH/GCP Guidelines.
  • If the PI or UACR has been audited by the FDA, and a 483 was issued, a copy of FDA Form 483 will be provided, upon request.

Site Requirements:

  • Dedicated exam rooms.
  • Dedicated office for UACR staff and study related files.
  • Locked and limited access drug and supply storage facilities.
  • Basic lab and equipment facilities for specimen and diagnostic collection. All lab and equipment facilities must be calibrated and certified as required by law.
    · Refrigeration and freezer capabilities or accessibility specific to the needs of the study drug.
  • Dedicated area for storage of study binders that has limited access and is secure.
  • Dedicated area for Sponsor monitoring visits that is well lit, comfortable and appropriate for monitoring staff.
  • Assign/ dedicated staff person trained as the Study Coordinator.
  • Assign/ dedicated technician/coordinator to conduct study related lab requirements for all assigned studies
  • Maintain a system for quickly identifying patients by diagnosis or condition (preferable a dedicated staff member who could conduct chart reviews during pre-screening/screening process for qualified patients).
    Should you have any questions, please feel free to contact us at 305-677-9297.