A Qualified Team You Can Count On

Our Leaders

Founder & President

Pete Shabe

Peter Shabe, the founder and President of Advance Research Associates, Inc. (ARA), has developed the company as one of the preeminent providers of data management, biostatistics, and statistical programming services to the pharmaceutical, biotech, medical device, and medical diagnostic industries. Peter is responsible for the business management and financial performance of the company.

Based on his many years of experience working as the principal biostatistician at sponsor companies and with ARA’s clients, Peter also provides statistical study design, clinical program strategic planning, and statistical input at meetings with regulatory agencies. Prior to founding ARA in 1996, he held positions of increasing responsibility in the biostatistics departments at various CROs and pharmaceutical companies including PAREXEL, Collagen Corporation, and Syntex. Peter enjoys teaching biostatistics to non-statisticians in the clinical trials programs at San Francisco State University and at University of California – Santa Cruz. Outside of work, Pete enjoys spending time with family and friends, listening to all types of music, and playing with his dogs.

Veronica Bubb | Executive Director of Operations

Vice President of Operations

Veronica Leah Bubb, DBA

Dr. Veronica Bubb, Executive Director of Operations and Consulting Statistician is responsible for overseeing daily operations across the company. Dr. Bubb is a seasoned executive who approaches clinical trial design and execution from a synergistic and interdisciplinary perspective to achieve operational excellence across all facets of the business.

In addition to her strong business acumen, Dr. Bubb has strong technical skills across the clinical research spectrum. She has led numerous complex study integrations (ISS/ISE and other CTD modules) for regulatory submission to the FDA. Veronica has served on numerous data monitoring committees in a supportive role as a DMC coordinator and as a voting and non-voting statistician. Her career as a statistician initially started in the software industry teaching and training clients on statistical methodologies used in Six Sigma and Lean quality improvement applications. From there she chose to focus on clinical trial applications as a statistical and regulatory consultant mentoring under a former director from the CDRH (Center for Devices and Radiological Health at the FDA). She has worked at large CROs in various leadership roles including the oversight and direction of partnerships with large, global clients spanning across many regulatory regions (PMDA, EMA, etc).

Dr. Bubb holds a Doctorate in Executive Leadership from Drexel University, a Master’s in Applied Statistics from Penn State University and a Master’s in Statistics from Virginia Polytechnic University. Her research interests are focused on innovative trial designs and protocol development. She is an active member within the American Statistical Association and serves on the program committee for DIA’s Innovative Trial Designs Conference.

Executive Director Clinical Data Management

Michelle Stoddard

Michelle is responsible for planning and implementing business development strategies for ARA in conjunction with the ARA President, organizing strategies for compliance with 21 CFR Part 11, CDISC and other regulations, guidance, or industry standards relevant to ARA, evaluating and managing vendor relationships and serving as project manager on a variety of projects and with multiple clients.

She has over 25 years of Clinical Data Management and Clinical Research experience in the Biotechnology/Pharmaceutical/Diagnostic and Medical Device Industry fields, as well as 19 years of Project Management experience.

Using her extensive knowledge of the structure and functionality of clinical databases and her understanding of clinical data and its translation into a meaningful database, Ms. Stoddard is able to successfully coordinate communication and completion of tasks between ARA and multiple clients. She works with clients to establish project timelines and tasks, disseminates tasks and assigns priorities to all members of the project team, and ensures client deliverables are met related to the scope of work.

Michelle holds a B.S. in Physiology from the University of CA, Davis. Outside of work, Michelle spends her time playing outside with every available chance.

Carole Matthews | Senior Manager, Programming & Data Standards | Advance Research Associates

Director Programming & Data Standards

Carol Matthews

As the head of ARA’s Programming team, Carol is responsible for planning and implementing process improvements that utilize SAS, SAS macros and other available technologies to maximize the efficiently of all programmers. She works across departments to determine where programmers can help increase overall project team efficiency, from generating complex database edit check listings to generating table output that is “drop-in ready” for medical writers. In these roles, she ensures that programming project timelines are met, performs project-related programming with an emphasis on figures, ad-hoc and project management-related tasks, mentors less experienced programmers, and provides input on programming time and resource estimates.

Carol has over 20 years of SAS programming experience in the pharmaceutical industry, working on the earliest phase clinical trials through leading large project teams working on complex US and EU submissions, three of which led to regulatory approvals. In addition to her extensive clinical trial experience, Carol spent over 5 years leading a team that focused on support for Risk Evaluation and Mitigation Strategy (REMS) tasks, including Knowledge, Attitude, and Behavior (KAB) surveys.

In addition to her work at ARA, Carol has been an adjunct faculty member in Thomas Jefferson University’s SAS Programming certification program since 1998, is actively involved with the annual PharmaSUG conference, and co-authored the book Validating Clinical Trials Data Reporting with SAS®, one of the first books on how to use SAS effectively for clinical trials programming.

Carol holds a B.A. in Psychology from The College of New Jersey. Outside of work, Carol enjoys riding her horses, fussing with her cats, making jewelry, and traveling with her husband.

SR. Quality Systems Manager

Andria Wallace

Andria is responsible for managing ARA’s Quality Management System, encompassing accountability and compliance with the industry requirements of ARA’s document management system, corrective and preventive action (CAPA) system, training, audits, and other regulatory requirements. As the ARA Data Protection Officer, she implemented and oversees the General Data Protection Regulation (GDPR) and California Consumer Privacy Act (CCPA) compliance obligations.

Andria has a master’s degree in Product Engineering and has a certificate in Clinical Trial Essentials from UC Santa Cruz. For the past 28 years she has worked in the areas of Quality Assurance, Project Management, and R&D for ARA, HP, and Microsoft. In her spare time Andria likes to travel, build things, and hike the Boise foothills with her dog Syd.

more than just data organizers

We build strength through communication.

Years in Business

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Clinical Studies Managed

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Companies with Multiple Studies