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.