OUTCOMES RESEARCHNovel Data,
Generate evidence for your digital solutions with a stratified evidence strategy.
Developing better healthcare solutions is paired with better methods of developing said solutions. A “gold standard” RCT may be required, but is rarely the only component of a strategic evidence plan for a Digital solution. Novel, real-world, and combination data/insights are highly sought after by today’s healthcare stakeholders.
Outcomes Research Capabilities
Real-World Data (RWD) and Real-World Evidence (RWE) Studies
Real world data leading to real world evidence are studies that require bringing together data points from a variety of sources including the patient and clinical data. RWE studies examine how a medicine, or a product is used by an intended population outside of a RCT. Medullan can work as a study partner to help accelerate and facilitate these studies, or we can act in the capacity of a full-service CRO. We help bring together partners who can ensure that the trial is collecting the right data, at the right times, in ways that are simple and effective for everyone involved.
Commercial & Value-Based Care Pilots
Commercial and value-based care pilots of digital studies are often the first time that products are being used in real world populations. They are the chance for sponsors to show how their products perform with individuals that have not been screened or consented into a clinical trial. Medullan helps sponsors choose and contract with high impact healthcare systems or other partner organizations who are key partners in the pilot. We help our clients design VBC studies, including endpoints, data collection, and analysis plans.
Decentralized Virtual and Hybrid Studies
Hybrid trials are becoming the de facto approach for clinical research. We help design and operationalize virtual and hybrid studies, working with investigators and sponsors in a variety of capacities. COVID-19 has changed the expectations for how many, if most trials need to be delivered. Whether your trial requires e-Consent, remote monitoring, telemedicine engagement, or implementation of wearables and devices, we can help you design, prepare and deploy these studies. We can work with your team to remove the complexity from hybrid.
Digital Medicine Validation Studies
Digital medicine products need to be developed along a strategic pathway that progressively builds a dossier of evidence. Clinical validation studies are often pivotal to garnering approval with regulatory bodies. Equally important is the need to build a broad dossier of evidence that supports both economic and clinical value propositions. Medullan works with digital medicine sponsors to help select study design and endpoints as well as contract with high impact partners organizations and healthcare systems. We navigate the logistical complexities of setting up virtual and hybrid studies for digital medicine validation and can run validation trials as a CRO.
Digital+ Combination Studies
Digital Companion products are solutions that help reduce patient drop-off and ensure a seamless patient experience. They are designed to address patients’ needs from more quickly diagnosing a disease, to better manage their condition, or more faithfully sticking to a prescribed treatment. Medullan can work with study sponsors to help choose and validate the most effective Digital+ and companion products and where needed, we can help choose the best wearables and sensor products commensurate with endpoints of interest. We work with sponsors to validate solutions prior to broad use and ensure that they are meeting benchmarks for patient engagement, follow-through and compliance.
We apply the right levels of validation to accelerate learnings and demonstrate outcomes for clinical acceptance and reimbursement.