Talented people. Inspired processes. Innovative platform. Biorasi’s basic components of delivering Clinical Research Optimized™.
What Makes Clinical Research Optimized™?
Clinical Research Optimized™ is more than a tagline. It’s who we are, what we do, how we do it, why we do it that way, and where we work. It’s a demand we make of ourselves, as well as a promise to the sponsors that work with us. Clinical Research Optimized™ is a combination of our people, our processes, and our platform to produce success for our sponsors in even the most challenging trials.
We have a saying: the ideal clinical trial costs nothing, was completed in a day, and already received regulatory acceptance. Clinical Research Optimized™ at its heart is the understanding that in the real world, every trial faces a unique set of requirements for time, cost, and risk. In order to succeed, these three factors have to be precisely balanced. By using our innovative TALOS™ platform and our team’s experience, we’re able to identify the optimal balance for each trial we run. We’re also able to spot problems before they occur, and build out solutions that result in success for our sponsors.
Biorasi was established in 2002 to help pharmaceutical and biotechnology companies accelerate the process of bringing safe, effective and reliable therapies to market.
Successful technology entrepreneur and company founder Boris N. Reznik, Ph.D., and his team analyzed the innovative therapeutics industry and realized much could be gained from applying sophisticated strategies, professional project management, information technology solutions, and dedicated project teams. As a result, Dr. Reznik and his team developed and introduced TALOS™, a unique system that combines a powerful technology platform, industry-leading training, and employee-owned culture focused on delivering impressive results for leading pharmaceutical and biotechnology companies. The goal and founding mission is to ensure approval of more life impacting drugs, by making the clinical development process much more efficient.
For more than a decade Biorasi has focused on refining the process and execution of clinical trials, ensuring that three key variables – cost, time and risk – are optimized at every step.
OUR GLOBAL REACH
Biorasi combines the personal care and attention of a boutique CRO with the global capabilities of market-leading full-service organizations. With offices in most major regulatory jurisdictions, we have the ability to run trials across the world or in our backyard, as the specifics of the trial require.
Our geographic distribution has given us experience across a wide range of regulatory environments, and in our time in the industry we’ve weathered all kinds of regulatory climates. Biorasi’s team understands the nuances of running trials in any given area or jurisdiction. We know, for example, that Type 2 Diabetes is diagnosed much earlier in the US than in India, or that informed consent is a personal decision in some jurisdictions and a family one in others. We know that some areas have frequent communications outages, and others are prone to work-stopping natural disasters during certain seasons of the year. We understand that patients view their doctors as gods in some countries, while patients in the US may not be so compliant with the doctor’s advice.
Biorasi uses this understanding to inform decisions made on behalf of our sponsors to accelerate trial completion and regulatory approval. This global approach is just one of the many tools in our toolbox that helps us to deliver Clinical Research Optimized™.
Clinical Research Optimized™ starts with hiring the best – biopharma industry and regulatory veterans, and promising young talent on the rise. It continues with rigorous training using the TALOS™ platform, an integrated tool that keeps every one of our employees operating at 100% at all times. We foster our talent with our unique mentoring program, and reward everyone with a stake in our company. Finally, Clinical Research Optimized™ hinges on strong leadership with a defining vision for our company, and with unparalleled commitment to excellence in the services we provide to our sponsors and partners.
Biorasi is an employee-owned company, which aligns our employees’ goals with our sponsors’ goals. We operate on a model of office-based teams, to give us maximum flexibility and agility in building out teams for each individual trial we run. In short, Biorasi’s human resources infrastructure was designed from the ground up not just to work, but to work for our sponsors.
Boris Reznik, PhD
Boris Reznik, PhD, is a veteran of multiple startups, and is backed by a track record of building companies across a diverse set of industries. Dr. Reznik leads Biorasi with a strong focus on processes and systems – a unique perspective in the CRO world.
Stephanie C. Finnegan
President, Divisional Operations
Stephanie Finnegan has over 25 years of experience in the biopharma industry, spanning executive leadership across finance, M&A, commercial strategy, GMP manufacturing/CMC, regulatory affairs, and clinical research. Ms. Finnegan brings a consultant’s mindset to Biorasi, helping the company stay focused on consistent and sustainable growth, fueled by a client centric approach.
Vice President, Project Operations
Lindsey Rios has been with Biorasi for nearly ten years, and understands complex projects better than anyone. Ms. Rios heads up a large, geographically dispersed team, and contributes heavily towards Biorasi’s operational excellence.
Senior Vice President, Process & Quality
Gary Urban comes to Biorasi after decades of experience in management and technology consulting. His insights and experience guide Biorasi’s continuous improvement. Mr. Urban is also the lead architect of the TALOS™ platform.
Vice President, Data Sciences & Biometrics
Jon Roth is an early pioneer in electronic data processing for clinical trials. Mr. Roth’s experience is a crucial component of Biorasi’s success as a data and bioinformatics leader.
Vice President, Drug Safety and Pharmacovigilance
Mark Vieder comes to Biorasi by way of the FDA, where his leadership role with the OSE allowed him to work closely with the Office of Generic Drugs, the Office of New Drugs, and Regulatory Affairs. Mr. Vieder now brings those years of experience, along with extensive experience in large pharmaceutical companies, to Biorasi.
Director, Client Solutions
Wayne Bowden is an accomplished researcher and executive, combining the scientific knowledge to understand the most intricate details of clinical research, and the business experience to shepherd those trials to success.
Vice President, Head of European Operations
Hartmut Schmied has over 25 years of experience in clinical research. He held high-level strategical positions in Project Management and Medical Affairs in pharmaceutical and CRO industry.