John N. Quiring, PhD
Founder and Chief Science Officer
The roots of QST go back to the year 1974 when John secured his first contract as a consultant to the Pharmaceutical Industry and shortly thereafter was responsible for the statistical component of the Westcort, (Hydrocortisone Valerate) Ointment, 0.2%, NDA. After a little more than a decade of successful consulting projects he incorporated his business endeavors in 1985 creating QST. Since the beginnings more than 65 pharmaceutical drugs and medical devices have been approved under his strategic leadership as CEO and statistician. In late 2012, John instituted an ESOP to which he sold a portion of his shares at the same time assuming the position of Chief Science Officer. In his new role, John is responsible for the scientific operations of QST. This includes nurturing QST’s research capabilities for developing evidence of the validity and utility of research products, and for communicating with the scientific and customer communities concerning capabilities and scientific product offerings. John also manages the scientific priorities of QST so that they line up with the overall mission and goals of QST.
John’s interest in structuring clinical development programs goes beyond presenting statistical methods at FDA to aligning clinical development programs to achieve advantageous product labeling.
John earned his PhD in statistics from the University of Minnesota in 1972.
Nancy L. Fitzgerald, MS, MBA
Chief Executive Officer
Nancy Fitzgerald has been with QST since 1998 in increasingly responsible roles including Statistician, Project Manager/Statistician, Director of California Operations, Director of Project Management, and CEO. Nancy is responsible for developing a strategic plan to advance QST’s mission and objectives and to promote revenue, profitability, and growth as an organization. Nancy is responsible for performing long-term financial planning and analyses, overseeing budgets and study execution, managing associated risks, supervising cash management activities, and executing capital-raising strategies. Additionally, Nancy oversees QST’s operations to ensure production efficiency, quality, service, and cost-effective management of resources.
Nancy is an experienced executive who is a well qualified leader of QST in the design and implementation of corporate strategies which align with clients’ needs with continuing focus on client satisfaction.
Nancy earned her Masters of Science in Statistics from Western Michigan University and her MBA from California Southern University.
Jason M. Proos, MS
Chief Technology Officer
Jason Proos joined QST in 1999 as a Biostatistical Analyst. Jason is responsible for planning, designing, purchasing, installing, monitoring, operating, and maintaining QST’s IT infrastructure, communications network, servers, workstations, and other related hardware and software. Jason is also responsible for administering and upgrading the facility security system, providing end user support to QST employees, assisting whenever feasible with facility management, and operating, upgrading, and maintaining the emergency power system. Jason is available for critical issues with any of the above 24 hours a day and his demonstrated leadership and management skills have kept QST’s IT systems running reliably while protecting the confidentiality and integrity of client data.
Jason earned his Masters of Science in Statistics from Western Michigan University.
Becky Budreau, Pharm.D
Director of Clinical Services
Dr. Rebecca Budreau has over 17 years of clinical research experience spanning both sponsor and CRO roles. After receiving her Pharm.D. from Purdue University, Dr. Budreau began her professional career as a CRA for Cook Group Incorporated monitoring cardiovascular, women’s health, and orthopedic trials in North America and Europe. During this time, Dr. Budreau provided oversight for an AAA endovascular graft device from pilot through pivotal studies, including contribution in the PMA application and participation in the FDA panel presentation for approval.
Dr. Budreau was then presented an opportunity to join the CRO industry, for which she has remained ever since. She has served in various roles within operations and client management, and has served as the liaison between Sponsors and the operational teams for a number of large, global programs for cardiovascular, oncology and women’s health sponsors. Dr. Budreau’s combined operational and strategic program experience has enabled her to lead global teams to successful operational execution of clinical studies and programs while ensuring exceptional quality.
Dr. Budrea earned her Doctorate of Pharmacy from Purdue University>.
Agi Buchanan, M.D., Ph.D.
Director of Medical Affairs
Dr. Agi Buchanan joined QST as Director of Medical Affairs in 2014. Agi is responsible for the leadership and management of all Medical Affairs functions as well as all Medical Writing activities within the company.p>
Dr. Buchanan's broad background prior to QST includes 15 years of experience as a medical writing executive and drug safety physician, an academic research/teaching (undergraduate and graduate) physician and a licensed practicing physician. As a director-level medical writer, Agi has led and contributed to many successful regulatory submissions for investigational drugs, biologicals, and medical devices in the US and the EU. Her experience spans numerous indications within oncology, pulmonology, cardiovascular disorders, gastrointestinal disorders, nephrology, hematology, endocrinology, neurology, infectious diseases, rheumatology, dermatology, psychiatry, urology, women’s health, and pediatrics (including neonatal). Agi is highly skilled at interpreting and reviewing large volumes of complex and integrated clinical data with a special eye for potential safety signals. Agi has designed a number of programmable subject narrative templates for individual studies as well as entire clinical development programs integrating a large number of studies to aid in the safety review of marketing applications by the authorities.
Dr. Buchanan earned her Doctorate of Medicine and her PhD in Neuroimmunopharmacology from Semmelweis University.
Veronica L. Powell, MS, MAS
Director of Operations
Veronica Powell joined QST in 2016 as the Director of Operations. Her responsibilities include senior management and oversight of the data management and statistics departments within QST. She is also responsible for the leadership and management of operations, including devising strategies to meet the corporate goals, driving the company quality service expectations, setting and meeting schedules and budgets, adhering to relevant SOPs, complying with regulatory requirements, coordinating training, and confirming the quality of deliverable products.
Veronica’s broad background prior to QST, contributes to her strong financial acumen, operational intellect, proven leadership skillset and scientific reasoning. In prior positions she has created departments, organizational structure and effectively lead and mentored staff across departments. Her direct client facing experience includes supporting many different industries including clinical, pharmaceutical, healthcare and manufacturing. She has experience supporting various indications such as Oncology, Cardiovascular, Central Nervous System Disorders (including Stroke and Dementia of the Alzheimer’s type), Gastroenterology, Dermatology, Neurology and Pharmacology. During her career, she spent some time in Washington, DC mentoring under a former director from the Center for Devices and Regulatory Health (CDRH) division of the Food and Drug Administration (FDA) specializing in device and diagnostic clinical trial support.
Veronica earned her Masters of Science in Statistics from Virginia Polytechnic Institute and State University and her Masters of Applied Sciences in Statistics from Pennsylvania State University.
Lori Davis, Ph.D.
Associate Director of Statistical Consulting
Dr. Lori Davis joined QST in 2016 as Associate Director of Biostatistical Consulting. Lori is responsible for biostatistical methodology and development for handling complex statistically focused challenges within clinical trial design, execution and reporting. Lori provides input on clinical trial design, randomization designs and strategy, statistical method design and recommendations, interpretation of statistical results, simulation and modeling and strategic regulatory consultation. Lori is also responsible for representing the company at client, scientific, regulatory and industry meetings.
Building on a framework of broad experience in the industry and strong communication skills allows for the highly effective application of her statistical knowledge and expertise. In prior positions, Lori has lead teams toward delivery of high quality results, served on many DMCs, acted as unblinded statistician for numerous complex interim analyses, and steered clients on paths toward successful trial execution. She has also contributed to the development and implementation of an introductory course for statisticians on Adaptive Design and presented at several conferences. Lori has numerous publications in a variety of peer-reviewed journals. Her experience spans many therapeutic areas including dermatology, oncology, infectious disease / vaccines, cardiology, autoimmune disorders, endocrinology, hematology, musculoskeletal pain and neurology. Lori particularly enjoys developing cooperative and constructive mutually beneficial long term relationships with clients and bringing development programs and products through to success.
Lori received her Ph.D. in Biostatistics from the University of Toronto, Canada in 2002. She earned a M.Sc. in Statistics from Queen’s University in Kingston, Ontario.
Laura Hatsis, M.S.
Manager of Statistical Bioanalytics
Laura Hatsis has 10 years of experience in clinical research both in academic and in industry settings. Laura started her career focusing in pediatric studies at the Children’s Hospital of Philadelphia mainly providing statistical support to a Phase IV Epilepsy study. From there she moved into a small CRO in the Greater Philadelphia area and held roles as a programmer and as a statistician on various Phase I studies. At this time as CDISC was gaining popularity, Laura was able to bring CDISC mapping in house by developing mapping processes from scratch. Prio to joining QST, Laura held a position as a project statistician providing statistical oversight and full project level support for Phase II and Phase III studies and many pivotal device trials. Laura has also supported various DSMBs both in analysis and in coordination efforts throughout her career.
Laura has been formally trained in SAS, CDISC standards, WinNonlin, R, and SPlus. She has worked in numerous indications including but not limited to central nervous system, gastrointestinal, infectious diseases, dermatology, respiratory, cardiovascular, and oncology studies.
Laura received her Master’s in Statistics from Temple University.
Brian R. Armstrong, MS
Associate Director, Clinical Data Standards
Brian Armstrong joined QST in 2003. During his tenure, he has held roles of Statistical Analyst, Manager of Statistical Services, Associate Director of Statistical Services, and currently Associate Director of Clinical Data Standards. He has provided/overseen statistical programming support for more than 20 FDA submissions, to both the drug and device divisions of FDA. Brian has also served as the QST Project Manager for more than 60 clinical trials, working in indications such as onychomycosis, asthma, emphysema, obesity, acne, psoriasis, atopic dermatitis, tinea pedis, hepatitis C, back pain, and women’s health.
During his time at QST, Brian has been pivotal in developing processes for output methods for tables, figures and listings, Clinical Data Interchange Standards Consortium (CDISC) dataset conversions, and submission of information for Bioresearch Monitoring Program (BIMO). He has been part of New Drug Application (NDA) submissions requiring data processing of multiple legacy study databases. As Associate Director of Clinical Data Standards, Brian is responsible for keeping QST in compliance with regulatory data collection and submission requirements.
Brian earned his Masters of Science in Industrial Mathematics from Michigan State University.
Dave Van't Hof, M.S.
Associate Manager of Statistical Programming
David Van’t Hof joined QST in 2011 and currently serves as Associate Manager of Statistical Programming. David is responsible for the effective leadership and management of statistical programming personnel and activities, including setting and meeting schedules and project analysis/programming hours, adhering to relevant SOPs, complying with regulatory requirements, coordinating training, and confirming the quality of the deliverable product. David has demonstrated proficiency in effective leadership of subordinates in meeting the programming and documentation requirements of the company as well as the company’s clients, process improvement, resource allocation, and coordinating training and development of personnel.
David earned his Masters of Science in Biostatistics from Grand Valley State University.
Tami L. Bullen, BS
Manager of Data Management
Tami Bullen joined QST in 1995 and has been the manager of the Data Management Department since 1999. Tami is responsible for leadership and management of all data management personnel as well as overall direction and guidance for the data management activities of the company. She is responsible for CRF design, database design, set-up and validation, edit check design, programming, and validation, query processing, database audit, and electronic data capture systems design and implementation. Tami is responsible for developing and implementing strategies and policies for data management aligned with maximizing quality and reliability of deliverables at an optimal level of efficiency.
Tami earned her Bachelor of Science in Mathematics from Grand Valley State University.