Study Design & Set Up
Suboptimal protocol design is a common cause of trial failure. When designing a decentralized trial, traditional site-based functions must be intelligently adapted to home-based solutions. To do this, you need the right technology and strong clinical understanding of how to best meet the needs of the trial. Whether you’re going fully virtual or planning for a hybrid approach, our trials are designed with the end in mind.
Our trial designers begin by establishing a clear overview of how all the component parts of the study fit together. For example, system programmed notifications or participant reminders are planned and designed in from the outset to facilitate flow, resulting in a more seamless experience for both sponsors and participants.
ObvioHealth’s innovative technology facilitates easy study design, but never dictates it. When choosing the best approach to outcome measurement, we look across the breadth of data collection options to choose the one(s) that will best deliver your endpoints.
ObvioHealth’s platform is built on a modular design, enabling us to more easily adapt to each project’s parameters. We have structured the platform to provide a range of options for each step in the trial journey. Because these options are pre-configured, the need for customized programming can be reduced or even eliminated, with positive impacts on both timing and budget.
ObvioHealth’s experienced clinical scientists can help you to assess the medical and scientific value of your product and reinforce the science underpinning your novel therapies, products and devices. Our in-house clinical science team is comprised of thought leaders with deep experience in industry best practices, FDA/EMA guidelines, and current literature. Our services include: PRO/ePRO instrument development and psychometric validation, concept elicitation, cognitive debriefing and usability testing, market landscaping, and the preparation of the SAP and biostatistical analysis.