Trial Design and Biostatistics
From Bayesian methods to traditional frequentist study designs, Databean’s statisticians have done it all. Don’t let your existing data go to waste as it may be a justification for a smaller-sized or shorter-duration clinical trial – saving time and money.
Our statisticians use trusted methodologies to:
Regulatory and Quality
Don’t burn time and money waiting for the regulatory agencies to communicate what they need — we can show you what works and what doesn’t. Our regulatory and quality teams have 30+ years of global experience in commercializing medical devices focusing on Class II and III products.
Our team can:
Databean provides knowledgeable and experienced managers who understand your urgency and will work hard to keep you on time and on budget.
Our project managers:
Data Management and Monitoring
Databean’s data management team all started in the trenches designing and managing clinical trials, both in academia and industry, and are experts at configuring TrialPoint™, Databean’s proprietary research management system. If you are new to electronic data capture (EDC), always thought it was too expensive, or don’t have the internal capacity to license and configure a system, let us help:
The transition from clinical development to marketplace introduction is critical to the success of any product. We offer a seamless transition to post-marketing surveillance and investigator-generated studies by harnessing the same tools used in the pivotal trial. By using a single data repository for all your clinical and marketing initiatives you will have powerful metrics at your fingertips whenever you need them.
If you are waiting to launch your product before formulating a path to reimbursement, it might be too late. To secure reimbursement for new technologies it is important to design clinical trials that show medical benefit, and to collect the necessary data to satisfy coverage decisions and coding.
During the design phase, Databean’s reimbursement specialists will work with you to phrase the intended use and indications for use to fit existing coverage decisions, or we will ensure that the clinical trials are designed to collect the necessary data to satisfy new coverage decisions.
When spend is too high and critical timelines are missed, it might be time to rethink your strategy. Databean has recovered three pivotal trials within the last 3 years and can help you get back on track. We start with a comprehensive audit to diagnose and prioritize issues, create redesigns and negotiate with agencies, establish relationships with KOLs and clinical sites, map and integrate data into TrialPoint, transition to new vendors as needed, streamline communication and day-to-day operations. If your study is not progressing as expected, feel free to give us a call and see if we can help.