Boris Reznik, Chairman
The profound surge in the global boom in the number of clinical trials has led to a massive increase in the volume of data pertaining to newer drugs, ailments, and their outcomes. Moreover, it is evident that the way biopharmaceutical companies conduct clinical trials is undergoing a notable transformation from the legacy methods. Coupled with this much-needed evolution are new sets of specific challenges associated with the increasing role of information technology in the space. Of the many problems related to the biopharmaceutical industry today, the critical need for greater operational efficiency as well as patient access and engagements in clinical drug development is paramount. Instituted to mitigate these setbacks in the medical trial industry is the Florida -based firm, Biorasi. “We solve the problem of patient access & engagement with data empowered insights, therapeutic expertise, and operational excellence, delivering faster higher quality trials,” says Boris Reznik, the Chairman of Biorasi.
With flat and even declining productivity, increasing research and development (R&D) costs, rising complexities of preapproval trials and extensive post-approval studies, and increasing regulatory demands, it is imperative that clinical trials are managed more effectively and efficiently. Biorasi is a full-service global CRO, instituted with the vision for a future where data, process, and technology work together continuously to accelerate drug development, benefiting their sponsors and patients’ lives. It possesses the industry-best expertise in managing the entire process related to clinical trials. The firm specializes in patient recruitment in complex trials, clinical trial methods, smart data risk-based monitoring as well as a trusted resource for trial rescue. Biorasi engages with leading names and most innovative life sciences startups in pharmaceutical space to improve clinical trial outcomes. “Our growth leverages our strong dedication to building true partnerships with our sponsors, and our commitment to moving the industry ahead through better project management, processes, technology, and people,” adds Reznik.
A one-of-a-kind Approach
Adapting the best-in-class approach that includes comprehensive pre-trial discussions, Biorasi successfully identifies the specific challenges its clients face and creates solutions that focus on their unique objectives. The firm believes that sophisticated project management with the backing of novel technology platforms, advanced methodologies, and dedicated team are the key ingredients of every successful trial and continues to be attentive in balancing them. Biorasi thus provides innovative and customized solutions that are capable of consistently delivering, highly successful, complex clinical trials, and allowing faster trial completion while minimizing their risk of failure.
Leveraging its technical edge and industry-specific expertise, the firm designs and executes trials around the needs of its clients, providing a unique trial management model, unifying teams and their processes with a proven methodology and technology. It ensures highest-quality, optimized clinical trials that accelerate drugs or devices to market while exceeding industry performance standards.
We solve the problem of patient access & engagement with data empowered insights, therapeutic expertise, and operational excellence, delivering faster, higher quality trials
Dedicated to enhance and streamline the clinical trial operations Biorasi brings to the table an innovative technology-driven platform, TALOS™, a clinical trial tool, built to deliver clinical trial faster and at a higher quality. This state-of-the-art solution integrates with all modern clinical trial software to collect sponsor data and other relevant information in one place. By aggregating and processing data from multiple disparate independent sources, TALOS™ enables project managers to have a global view, allowing them to spot potential issues before they turn into crucial problems. Unlike its competitors, the company uses big data principles to bring together thousands of variables to dynamically optimize sponsors’ trials, giving its team insights and options that are not available to other CROs. Biorasi leverages this source agnostic platform to make managing clinical trials more accessible and better by aggregating data, translating it into the usable analysis. TALOS™ ensures data transparency and allows accessibility through on-demand and real-time dashboards.
Navigating Complex Clinical Trials to Approvals
Having a value-bound tool onboard and its one-of-a-kind approach, Biorasi positions itself as one of the key service providers in the clinical trial space, offering a wide range of services to its clients. Project Development being the primary and predominant element in medical research, the firm pays significant attention in this direction. Employing a dedicated consulting group that comprises of cross-disciplinary subject matter experts, including regulatory professionals, doctors, scientists, legal experts, and experienced clinical teams that work in tightly integrated groups, Biorasi builds better clinical development programs. Realizing the necessity of clinical trials being a part an optimized and effective drug development program that benefits the global medical needs, the firm helps its clients to identify which pieces can be improved for long term success. It provides all required resources enabling its clients to execute a comprehensive clinical trial complying with regulatory specifications, thus leading to approval.
Disrupting the Legacy Trial Management Methods
Biorasi believes that structurally sound project management coupled with dedicated and well-trained project managers, and industry-leading process and innovative tools can ensure trial success.
Committed to providing best-in-class project management, the firm leverages its industry-specific expertise and longstanding experience to transfigure legacy management methods used in the clinical trial space to revolutionize the process ensuring industry-best outcomes. Biorasi’s proprietary TALOS™ structure employs high-end internal and external tools to ensure that projects are completed according to its clients’ requirements. Optimization, Guidance, and References capabilities of TALOS™ use historical data and institutional learning to identify potential problems associated with project execution before their occurrence, preventing the chances for critical mistakes. This solution-driven mentality enables the firm to serve its clients in all mission-critical areas successfully.
TALOS™ uses a scientific approach to Project Management; it breaks down complex tasks into simple actions enabling a plain sailing operation and ensuring efficiency. Biorasi’s project management services also include management of project deliverables, timelines, and budgets, project metrics tracking and reporting, global project plan development, coordination, and conduct of project team meetings, including investigator meetings. On top of that, vendor mobilization and management, Trial Master File set-up and maintenance, study transition handover and management, and executive-level account oversight are also a part of its customer-specific service portfolio. “Our clinical team is always supported by a control center that coordinates, manages and acts as an additional pair of eyes to verify all trial data,” says Reznik.
"Our growth leverages our firm commitment to building true partnerships with our sponsors, as well as our commitment to moving the industry forward through better project management, better processes, better technology, and better people"
Heading the Game with Strategic Partnerships
With its result-driven value proposition, Biorasi has already extended its footprints in the clinical trial landscape by catering to a wide range of needs in the pharmaceutical industry. The firm manages trials across the world, with offices in most major regulatory jurisdictions and its geographic distribution has given Biorasi experience across a wide range of regulatory environments and global cultures. Leveraging this local knowledge to predict the challenges better and make informed decisions, it continues to accelerating trial completion and regulatory approval.
Zealous to widen its client base and further sharpen the edge of its tech-stack the firm was on a drive to reduce costs, overhead and time spent on building clinical trials. Having this strategy on the anvil, the firm was in search of a data science partner who could potentially reduce the development lifecycle of the drugs Biorasi was helping to get to market and do so at a reasonable cost. The company, after a comprehensive bidding process, selected IBM Watson Health and its IBM Clinical Development solution to partner with. “It allowed us to get up and keep running on studies much faster than we could with other systems, thanks largely to their streamlined and intuitive design,” concludes Jon Roth, Vice President of Data Science at Biorasi.