BIA Clinical Group

SERVICES

Operational Execution and Oversight

Oversight of your clinical program, specifically the data, is key to a positive study and ultimately a successful regulatory filing. Most clinical trial failures are preventable. BIA has proven expertise to proactively mitigate potential data quality issues by providing excellent oversight throughout the entire project.

We can provide experienced resources to augment your team, functioning as a virtual project team to ensure your programs stay on track and eliminating last-minute surprises.

Data Review and Rescue

BIA has extensive experience in the remediation of data quality issues within study databases. We determine exactly where the raw data issues are, and then write and resolve queries.

In terms of statistical programming, regardless of your study has known problems or if you want to proactively check the quality, BIA can pinpoint where the issues are with your SDTM and ADaM datasets and output deliverables, and then work with your CRO to get them resolved. BIA will give you peace-of-mind that there won’t be any data-related or statistical programming-related issues that can derail your end-game activities.

Clinical Strategy

Clinical Strategy from pre-IND through submission is critical to program success. Many studies and ultimately programs fail due to suboptimal efficacy endpoints, flawed study designs, inappropriate data collection and analysis, and problems with study operations. BIA can help you strategize before your project begins, to ensure that you are set up for success and the best possible outcome.

TMF Health Check

The quality and completeness of your study’s Trial Master File (TMF) is critical to your company being inspection ready at all times. Has your TMF been contemporaneously maintained throughout the lifecycle of your study? If not, you should be concerned. BIA has extensive experience reviewing TMFs, identifying potential gaps and solutions to help get TMFs back on track.

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).