BIA Clinical Group

ABOUT US

BIA Clinical Group, LLC is focused on supporting clinical development for pharmaceutical, biotech, and medical device companies large and small. We specialize in operational execution and oversight, data review and rescue, and clinical strategy, with a focus on data quality and integrity. Our company is led by our Founders, who have a combined experience of more than 100 years in the pharmaceutical/biotech industry. Our team has expertise in Clinical, Project/Study Management, Statistics, Statistical Programming, Inspection Readiness, Monitoring, Data Management, and Safety.

BIA can function as a virtual project team in all phases of clinical development, ensuring that your critical program is set up for success from the very beginning. BIA has proven expertise to proactively mitigate potential quality issues by providing excellent oversight throughout the entire project. For clinical programs already underway, we can identify the source of the problems, whether at the clinical sites, with the CRO, with an external vendor, or with project oversight. BIA’s experience reviewing data in real-time or at various time points during study execution will ensure quick identification of the issues and reasonable remediation actions to help get your project back on track. We will work with you to ensure your study has clean and meaningful data that is on-time and within budget.

Our goal is to help you get to market as quickly and efficiently as possible. We have seen many companies outsource their critical studies or programs, without proper oversight. Later, they learn that irrelevant and/or the wrong data was captured, ideal patients were not being tested, the study was not being conducted or monitored as planned, or there were issues with the statistical programming of the datasets or output deliverables. When any of these occur, BIA can partner with you to identify and remediate issues, and rescue your study.

Carrie Guss, MSBA, RDN

Carrie is an energetic and quality-conscious drug developer with an eye for detail and over 23 years of experience leading teams for the largest and smallest companies. She has extensive experience planning and executing Phase 1-4 clinical trials through study reporting and submission, including rescue of projects outsourced to CROs for many clients. Carrie has established and led high-functioning R&D departments from the ground up, bringing several drugs to market from study start through the compiling, review and submissions of NDAs, ANDAs, EUAs and other filings. She is skilled in clinical operations, cross-functional leadership, study management and monitoring, vendor selection, management and oversight, contract and budget negotiations, clinical data review, inspection readiness, and review of regulatory submissions. Carrie has served on medical, regulatory, and legal review boards to ensure corporate compliance of promotional material. She has participated in numerous regulatory meetings in the US, Canada, China and Europe. Her therapeutic experience includes cardiovascular, metabolism, pain and inflammation, dermatology, oncology, women’s health, pediatrics, and nephrology- both dialysis and non-dialysis.

Theresa Stern, PhD

Theresa is changing the industry one study at a time with her ability to ensure data quality and integrity, every step of the way. She has over 23 years of experience in the biotechnology, ethical pharmaceutical, medical device, and consulting industries. Theresa has extensive experience leading complex, clinical data rescue programs and is an expert in performing data reviews. She also has broad experience in providing oversight into clinical study execution for data management, statistical programming and statistics. Theresa routinely provides statistical strategy support for the development of clients’ clinical trial programs, while also providing operational execution of studies through writing SAPs and providing statistical input to protocols, top line reports, and clinical study reports; and programming and interpreting statistical analyses. She has served on numerous Data Monitoring Committees. Theresa has held various positions at Parke-Davis Pharmaceutical Research; Pfizer, Inc; Metabasis Therapeutics, Inc; PAREXEL International; Aastrom Biosciences, Inc; and at her own consulting company, TPS Pharmaceutical Consulting. She has worked in the cardiovascular, metabolism, endocrine, central nervous system/insomnia, women’s health, and oncology therapy areas.

Rebecca Bakker-Arkema, RPh, MS, FAHA

Becky has over 30 years of clinical research experience in the pharmaceutical industry in translational medicine, and clinical program strategy and development from Phase 1- 4. Becky has worked at Upjohn, Parke-Davis, Pfizer, GE Healthcare, AlphaCore Pharma, Metabasis, Gemphire Therapeutics, Aastrom, Ritter, and LIB Therapeutics on oral, imaging and injectable compounds, managing several programs and over 40 clinical trials. She was a member of the Pfizer Global Research and Development cardiovascular management team where she made significant contributions to the clinical development of Lipitor. Leading clinical research at AlphaCore, Becky developed an early compound through Phase 2a to acquisition. She has over 50 publications in peer reviewed journals and scientific presentations, is a Fellow of the American Heart Association, and is an adjunct Clinical Associate Professor at the University of Michigan School of Pharmacy. Becky has experience in the areas of cardiology, endocrinology and metabolism, thrombosis, and imaging (specifically, neurology an oncology).