DataThreads

Increasingly favorable regulatory guidance coupled with growing utilization of RWD in clinical trials has opened a door of opportunity for both data asset managers and sponsors, but the opportunity is not without its challenges. From the sponsor perspective, these challenges are best defined by these commonly asked questions: How can I use RWD to derisk my program and attract investment? What data sources are suitable to answer my research question? How do I evaluate a RWD source? What are the implications of using RWD on phenotype identification and endpoints? How can I integrate RWE into my regulatory strategy? As an independent advisory with deep connections with the leading companies and thought leaders in the industry, DataThreads helps navigate all of these questions, creating uniquely tailored strategies and partnerships that provide insights supporting key decisions and overcoming research challenges. DataThreads is managed by a seasoned industry expert who has led partnership discussions delivering hundreds of millions of dollars in value to sponsor programs and built multi-party engagements creating novel value creation opportunities. For RWD asset managers and analytics providers who want to increase engagement in the clinical development space, DataThreads can assess the market readiness of existing offerings, identify the ideal market entry point, and explore strategies to enrich existing assets in order to meet future marketplace needs. For sponsors, DataThreads delivers a cost effective and comprehensive solution to RWD/RWE partnership strategy that represents a uniquely unbiased approach to data sourcing, study design, regulatory strategy, and execution.