BIA Clinical Group | Monitoring

MONITORING

The foundation of well-run clinical studies is the quality of the monitoring

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Study Specific Foundational Training for CRAs

A well-run trial requires that CRAs truly understand critical aspects of the protocol, investigational product, study conduct and various data points. Given today’s environment of global and remote monitoring, it is critical the monitoring team has study specific training with emphasis on key information, which lays the foundation for site training, monitoring, and ensures study success. BIA collaborates with clients to provide the critical study specific training of CRAs prior to site initiation and key study milestones, ensuring consistency throughout the trial.

Monitoring

BIA has built a team of US-based CRAs, who are fully trained on the BIA way of monitoring. These high-quality monitoring services ensure that sites are well managed throughout the study, and that proper oversight is maintained.

Monitoring Oversight

Now more than ever, monitoring oversight is a critical component to managing a well-run trial. FDA’s guidance for a risk-based approach to monitoring requires even more oversight of Sponsor’s critical data. Sponsors need to ensure that oversight is ongoing throughout the duration of the trial and is well documented.

If you have outsourced your monitoring to a CRO, BIA can provide monitoring oversight services to ensure that every site is being managed and monitored per the protocol, monitoring plan, GCP and FDA guidelines. If you are struggling with the experience of your CRAs, turnover, quality of monitoring, site coverage and even deviations, BIA will work with you to create an oversight plan to get the trial back on track. The plan will identify the specific issues and sites at risk, using our proprietary monitoring oversight checklist.

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).