Company History

QST Consultations, founded in 1974, offers quality statistical consulting services to suit the needs of pharmaceutical and medical companies by providing personalized service with a high degree of technical expertise. The company's portfolio embodies a diverse range of therapeutic indications with specialization in the analysis of medical device, pharmaceutical, and animal studies. The President and Director of Consulting, John N. Quiring, Ph.D., has more than 30 years of experience consulting with clients regarding the design, conduct, and analysis of their studies and representing them in front of the FDA.

Service to the medical device and pharmaceutical industry centers around analysis of clinical trials data, preparation of clinical/statistical reports, and compilation of the regulatory filing. Support to the client begins by developing, researching, and selecting the appropriate statistical methodology for the clinical trial. Statistical advice on the design of clinical studies is provided through the company's extensive experience in protocol review and development. Following approval of a submission, further support can be provided to assist with product launch endeavors and to develop crucial post-marketing investigations.

Services for pre-clinical animal studies include statistical processing and report writing. With experience from over 75 studies, the knowledge gained spans such areas as food consumption, body weight/gain, clinical pathology, hematology, clinical chemistry, urinalysis, organ and percent organ weight, pharmacokinetics, and reproduction/teratology.

Data services include development of case report forms and translation of raw case report data to electronic media with double-entry verification and edit check processing. Also, conversions of client databases are provided. Data is routinely received and transmitted electronically. These data may be source data, programs, or word processing files containing the statistical reports for incorporation into the client's submission. Responsibility for overseeing the databases of more than 170 clinical studies manifests our experience in database architecture, programming, and data management.
QST takes pride in the quality of their statistical report writing, specialized formatting of tables, and detailed graphics. Reports are furnished in Microsoft Word® and PDF formats. QST has co-authored the clinical sections of several FDA submissions and has experience producing submission-ready eCTDs.

Further client support services include participation in FDA/client meetings and preparation of strategies necessary to achieve optimal results in these meetings. Dr. Quiring has spent many hours in face-to-face meetings with the FDA and has testified as an expert witness concerning the statistical interpretation of study data.
QST’s computing environment represents an integration of state-of-the-art hardware technology and commercially available software products with proven track records. The core products used in the data management, statistics, and word processing environments include Entrypoint® Plus, SAS®, Microsoft Word®, and Adobe Acrobat®. Entrypoint® Plus meets or exceeds all of the requirements of the FDA; SAS is the standard for processing statistical data; Microsoft Word® is widely used within the industry; and Adobe Acrobat® is the standard format for electronic document submissions. Integrating these and other systems provides high quality computer support throughout the entire project. In addition, we continually evaluate our efforts to implement standards that meet 21 CFR §11 through careful selection and integration of hardware, software, process development, SOP’s, and training.

Confidentiality and protection of client data is a high priority. All Windows-based computers are part of a secure network infrastructure with all data stored on a central server utilizing the Windows 2003 Server operating system. The system is backed up daily with archived backup tapes stored off site.