Guidance grounded in proof, not promises.

Chris O’Brien brings over 20 years of experience in building operational excellence across regulated industries. In his role as CEO, his responsibilities include setting the business strategy for Biorasi, as well as recruiting and coaching extraordinary people and developing a culture of high performance. Previously, Chris served as President and COO at Decision Resources Group and was responsible for operating a 1000+ person healthcare data and insights business. Chris holds an MBA from the Amos Tuck School at Dartmouth College and received his BA in English Studies from Middlebury College in Vermont.

Mike Vitek is a senior financial executive who brings over 30 years of experience in all aspects of accounting, auditing, and financial management. As CFO, Mike’s role involves overseeing finance and accounting functions at Biorasi. Prior to his current position, Mike has held CFO, Board Advisor, and General Manager posts with both public and private companies. These include private equity portfolio companies in oilfield services, consumer goods, manufacturing, gaming, and hospitality industries. Mike received his BS in Business Administration in the field of Accounting from the Ohio State University.

Kristen Reis brings over five years of administrative experience in supporting executive teams and their initiatives. In her current role, Kristen’s responsibilities include managing the day-to-day operations of the executive leadership team, supporting projects in various branches from Human Resources to Marketing, planning company-wide events, and managing relationships. She received a BA in Sustainability from Florida International University.

Cathy Gooch has over 25 years of experience in Human Resources, Talent Acquisition, Resource Management, and Career Development within clinical research and the CRO industry. In her current role, Cathy is responsible for the overall leadership and strategic direction for all matters concerning People Operations, Talent Acquisition, and Biorasi Culture – fostering a diverse workplace that enables all Biorasi employees to contribute at their full potential. Previously, Cathy served as Senior Vice President of Talent and Resource Management at Linical, a global CRO, where she was responsible for Human Resources, Talent Acquisition, and Resource Management. Prior to Linical, Cathy worked with Chiltern, a global CRO, serving as the Executive Director of Talent Acquisition, Human Resources, and Resourcing Solutions (FSP). Cathy holds an MBA in Human Resource Management from Columbia Southern University and a BA in Human Resource Management from Georgia State University.

Mike Rudolph brings over 18 years of experience in infrastructure, support, and IT operations for GxP companies. In his role as Senior VP, Data Sciences and Technology at Biorasi, Mike is responsible for IT strategy and operations, software development, and business intelligence. Previously, Mike served as Head of IT at Goodwin Biotechnology, and led a multi-year effort to launch a validated client server environment, including enterprise, quality, laboratory, and manufacturing management systems. Mike holds an MS in Information Systems and Operations Management from University of Florida.

Sara Vaidya has over 16 years of experience in clinical data management, including EDC systems, CDISC standards, Alliance management, statistical programming, and biostatistics oversight. As VP of Data Sciences and Biometrics, Sara is responsible for providing advanced data solutions to improve healthcare outcomes with a focus on developing partnerships routed in quality, efficiency, and transparency, end-to-end data sciences management, global leadership of the Data Sciences team, and metrics-driven performance oversight. Prior to joining Biorasi, Sara served at SIRO ClinPharm CRO in an Alliance management role responsible for end-to-end data services, customer engagement, project management, statistical programming, and key areas of medical writing. She received her MS in Biotechnology from the University of Mumbai.

Renée Corcoran has over 16 years of experience across multiple compliance and quality management roles, focusing on building quality teams, effectuating quality management systems and clinical trial industry training, and facilitating issue management for Corrective and Preventive Actions (CAPA). In her current role, Renée leads the Quality Assurance department, providing strategic direction and oversight for quality management activities, including quality-controlled documentation, issue management, and client audit/inspection readiness. Previously, Renée served as Chief Compliance Officer at Medable, Inc., implementing both the quality management system and learning management system, as well as achieving ISO 13485 Quality Management Systems for Medical Devices certification. Renée holds a BS in Marketing and an MS in Instructional Technology from UNC Wilmington, as well as CQA, PMP, and Lean Six Sigma Black Belt certifications.

Nancy Newark has worked in clinical research for over 25 years and is an accomplished project management and clinical operations executive. She has extensive experience leading complex multi-faceted research programs and global teams. Her research expertise, combined with her experience as a registered nurse, has provided a broad range of therapeutic experience including but not limited to cardiovascular (acute coronary syndromes, heart failure, PAH, hypertension), metabolic (diabetes, obesity), acute and chronic renal failure, rare diseases, liver disease, and gene and cell therapy. Prior to joining Biorasi, Nancy served as an Executive Director of Project Management at Worldwide Clinical Trials. Additionally, she previously worked at the Duke University Medical Center as a registered nurse for 11 years with 14 years at the Duke Clinical Research Institute.

Paige Queen has over 18 years of experience in clinical monitoring, clinical operations, and project management across the pharmaceutical and CRO industry. As Head of Clinical Operations, Paige is responsible for quality delivery of clinical activities on all Biorasi projects, global leadership of the clinical team, resource management, performance oversight, and training strategies. Previously, Paige served as VP of Clinical Operations at Total Clinical Trial Management and was instrumental in the long-term growth and development of the company. She received her BS in Biology from Texas Tech University.

Cara Jacobs brings over 25 years of extensive legal and management expertise to the Pharma/Biotech industry. Currently, she leads the Legal function, providing strategic guidance on commercial and clinical trial transactions, policy development, legal strategy, and compliance. Prior to her current role, Cara held the positions of Vice President, US Clinical Development Site Head & Senior Counsel at Idorsia Pharmaceuticals, Director & Attorney at Quintiles, and Pharmaceutical & Medical Device Litigation Attorney at Shook, Hardy & Bacon LLP. Cara is a graduate of the University of Missouri-Kansas City (JD) and Truman State University (BS).

Dr. Sagar Patil has 20 years of experience in healthcare and pharmaceutical/biotechnology R&D, focusing on drug development and project management. In his current role as Executive Director of Asia Regional Operations, Dr. Patil is responsible for strategic development, business operations, project oversight, resource management, and business growth. Prior to his current role, Dr. Patil was Interim Country Head of India Operations for Amgen, a pioneer in the biotechnology industry. Dr. Patil received his MBA from the United Business Institutes in Brussels, Belgium, and holds a Medical degree from Mumbai University.

Evgeny Poltanov, MD, PhD brings over eighteen years of intensive experience in the fields of pre-clinical and clinical research, with a deep understanding of clinical development processes in the Eastern European regulatory environment. In his current role, Dr. Poltanov’s responsibilities are focused on developing growth strategies for operations and clinical research in Eastern Europe. Prior to joining Biorasi, Dr. Poltanov worked as a clinical operations director for Synergy CRO, providing strategic direction, leadership, and management across multiple company divisions to ensure the achievement of project goals within cost, time, and quality requirements. Dr. Poltanov received his MD from the Russian State Medical University with a PhD in Biology, focusing on antioxidants and photochemistry.