Real World Evidence Consulting
We help pharma and biotech companies in the planning, execution, and scientific communication of real-world evidence studies to support regulatory submission and market access.
Support your value story with innovative approaches in real-world evidence generation
Real-world evidence (RWE) has become a veritable necessity for continued commercial and regulatory success of new drugs and devices. The 21st Century Cures Act places additional focus on the use of real-world data to support regulatory decision-making, including both new drug applications and label expansion for approved drugs and devices.
Star Biopharma LLC is proud to be a certified Women-Owned Small Business (WOSB) by the US Small Business Administration.
Hear From Our Experts
Star Biopharma's team of industry experts helps determine the best research approach and conducts scientifically robust studies to capitalize on the use of real-world evidence for your stakeholders from pre- to post-launch and lifecycle management.
Regulatory Preparedness
Regulatory preparedness requires consideration and integration of real-world data as supportive evidence for a new drug application. Further understanding and incorporation of patient prioritized endpoints is an integral component of benefit/risk assessment per new FDA guidelines. We have the experience and expertise to generate the data that will be meaningful and relevant to the regulatory stakeholders.
Launch Readiness
Our team of health outcomes scientists can help prepare your organization for discussion with Health Technology Assessment bodies. We can prepare for and lead negotiations, follow-up discussions, assist in information sharing and dissemination to help HTA bodies make informed decisions.
Scientific Communications and Publications
SBC's team of certified medical publication professionals can help with a broad array of publication services including development of a scientific communication platform, publication strategy, manuscripts, abstracts, white papers, and conference presentations.
Post-authorization Commitments
We can support your post-authorization commitments for evidence generation. SBC can help identify the best research strategy including the most suitable databases for drug utilization studies, post-authorization safety studies, post-authorization effectiveness studies including disease and drug registries.
