Quality Management and Standards

All scientific research and drug discovery development projects will be performed by Therapath, LLC, under CLIA but not-GLP conditions.  The activities will be conducted under the responsibility and oversight of the sponsor with collaborative efforts from the dedicated study team from Therapath.

Therapath maintains a Quality Management System that consists of written policies and procedures that outline the processes necessary to (1) monitor, evaluate and improve the quality of laboratory performance, (2) prepare accurate, reliable and prompt reporting of results, (3) assess and maintain staff competency, (4) assess and resolve problems, (5) maintain quality management data for the purpose of substantiating that all tests performed and reported conform to the laboratory’s performance criteria.  The plan is designed to judge the quality of testing performed and to provide a system to identify and correct any problems detected.  The Laboratory Director is responsible for the overall program and for any correction of any problems detected. 

The developed study plan will be utilized as the framework in supporting clinical trial participation with our sponsors.  The system will be implemented, and if needed, adjusted at the direction of the Study Director if there is a detection of any issues not covered by the original draft of the protocol.

The Laboratory Director participates in the development and then approves the company’s participation in all projects.  The Company will perform services for the client  in accordance with the provided protocol and in conjunction with CLIA and the standards established by the College of American Pathology.  Therapath provides confidentiality training to all staff and in specific to the staff assigned to this project.

The medical team at Therapath is available for consultation during the development of the study plan and throughout our participation in the program.

Consistent reliability

Small Nerve Fiber Density Analysis in Skin Biopsies (Epidermal and Sweat Gland)

Therapath provides quantitative analysis of epidermal sensory and sweat gland nerve fiber densities, enabling comparison between treatment and control groups at different time points along the course of the study. Given its unique expertise and proven reliability, the company has been selected as a research partner by some of the most respected medical centers and pharmaceutical companies around the globe.

  • Each prepared slide is read by a Board Certified Neuropathologist
  • On-going Intra Rater and Inter Rater quality analysis programs are in use
  • Comprehensive Quality Management program

Muscle and Nerve Biopsy Services

The muscle and nerve leadership team has over 60 years of combined experience and expertise. Therapath has been selected by research partners to participate in international multicenter studies that require both expertise in muscle and nerve biopsy analysis, and the ability to develop customized tools for evaluation and reporting that interface with data management systems that meet study specific requirements.

  • Each prepared slide is read by a Board Certified Neuropathologist
  • QA/QC regularly assessed with readings from 2 readers
  • Routine and Customized Histologic and Immunohistochemical Stains of Muscle and  Nerve specimens
  • Teased Fiber analysis available for nerve specimens