Eliminating the costly disconnect between biostatistical programming and clinical narrative authoring. We speak fluent biometrics to ensure first-time-right outputs.
In most drug development programs, Data Management (DM), Biostatistical Programming, and Medical Writing operate in rigid silos. Medical writers wait passively for months until the Database Lock (DBL) to receive hundreds of Tables, Listings, and Figures (TLFs).
When the writers finally examine the tables, they discover that key subgroup comparisons are missing, patient disposition categories are inconsistent with the protocol, or statistical models fail to address regulatory endpoints. The result: frantic ad-hoc re-runs, programming delays, and blown submission timelines.
Kensai Health flips this paradigm. We partner upstream with your internal biostatisticians or external CRO programming vendors, auditing Statistical Analysis Plans (SAPs) and Mock TLF shells long before the data freeze.
We review draft Statistical Analysis Plans (SAPs) and Mock Shells with an author's eye. We ensure that efficacy endpoints (primary, secondary, exploratory), safety tables, and demographic summaries are structured logically for CSR authoring.
We participate actively in Blind Data Reviews and dry-run table generations before Database Lock (DBL). By testing dummy data against draft CSR shells, we identify programming ambiguities and raise real-time data management queries early.
Drawing on over two decades of experience evaluating and managing third-party contractors, Kensai Health assists sponsors in issuing RFPs, assessing statistical capabilities, negotiating vendor work orders, and keeping external CROs accountable to delivery dates.
Global health authorities (US FDA and EMA) mandate standardized CDISC datasets. We coordinate with statistical programmers to verify that ADaM analysis datasets and Reviewer Guides (ADRG/SDRG) reflect the clinical narrative seamlessly.
We translate intricate biostatistical models—such as Kaplan-Meier survival estimates, Cox proportional hazards, mixed-effects models (MMRM), and logistic regressions—into clear, intuitive medical narratives.
We support sponsors with exploratory post-hoc data analyses, bibliometric mappings, and quantitative synthesis for peer-reviewed journal submissions and health technology assessments.
How proactive biostats synergy saves sponsors weeks of critical path timeline.
