Research Pipeline:

Internal Data Analysis

We can help you understand what data you already have, and how to leverage those data into assets that will build credibility with the stakeholders you care about. After creating a strategic pipeline of analyses, we can do those analyses, or help you find academic research partners to expedite output. We can also identify gaps in the data you currently have, and offer ways to create a richer data pool for future analysis. Lastly, we can help you disseminate research findings and build scientific clout with peer-reviewed publications and other public-facing assets.

Research Pipeline:
New Studies

Some companies can succeed with internal data analysis alone, but others must do HEOR and RCTs to achieve their goals. We can help you understand the ROI of conducting a study - then advise on everything from needs assessment and study design to budget, staffing, and vendor selection. We don't execute studies, but we do offer protocol writing services and hands-on advising on how to execute study protocols, where needed.

Product Design &

Development

Science-driven digital products draw on decades of evidence to create real impact for patients. We can help you understand the clinical viability of even the most complex therapeutic area -- has anyone successfully intervened there? If so, how did they do it? What level of consensus is there in the literature on the best approach to use? What is the overall chance of success pursuing the therapeutic area? From there, your product team can take our clinical blueprint and create a product with the highest chance of success, or we can do the foundational work for you to understand what patients in your therapeutic area need and want out of a digital product.

Research and Regulatory Strategy

With years of experience in the relatively new field of SAMD, we can help you understand your options for regulatory classification of your DTx product, and the evidence needed to support whatever classification you choose. We are experts on comparison group selection and design, including shams, and we help DTx and pharma companies design feasibility and Phase III studies. We offer protocol writing services and can advise on preparation for FDA presub meetings that discuss evidence generation strategy.