Prompt-to-Decision p2d™ Knowledge Assets
Our inter-disciplinary team of domain experts have created a set of Knowledge Assets that are hyper-contextualized to the intended usage scenario and are seamlessly integrated with the existing workflows
End-User Personas & Real-World Use Cases
Regulatory Profiles
BQP, IND, NDA, ANDA, SNDA, 505(b)(2), BLA, 501(k)
FDA submissions created using external and protected proprietary knowledge bases, targeted at Regulatory Specialists & Medical Affairs teams. Integrated with CTMS, Knowledge Management / Submission Review Systems
Clinical Trial Protocols
Study Design, IRB Submissions, Statistical Analysis Plan
Clinical Trial protocols generated through disparate knowledge sources targeted at Clinical Investigators, Medical Writers, Biostatisticians, Epidemiologists, CRO members. Integrated with CTMS, eTMF, KMS
Efficacy Safety Profiles
Clinical Efficacy, Safety, Toxicology Summarization Profiles
Clinical summarization and synthesis for interventions targeted at DSMB members, Investigators, Pharmacologists, Medicinal Chemists, Medical Affairs teams. Integrated with CTMS, KMS, eTMF
Systematic Reviews
GRADE-compliant Summary of Findings
Evidence Profiles created through a network meta-analysis targeted at Guideline Panelists, Academic Researchers, Clinical Investigators.
Integrated with Systematic Review Tool, KMS
RWE-LDE Concordance
Real World Evidence & Literature Derived Evidence Concordance Profiles
Evidence summarization and synthesis for concordance between RWE findings and evidence from clinical trials targeted at Epidemiologists, Clinical Analysts, Clinical Investigators. Integrated with KMS.
Biopharma Intelligence
Research Q & A, Competitive Intelligence, Unmet Needs Analysis
Evidence synthesis for TCP/TPP, mechanisms of action, drug pipelines, effectiveness, targeted at Business Development Executives, Strategy Teams, Heads of TA Products. Integrated with Analytic Solutions