From protocol to publication
Regulators accept the conclusions they can trace. Alethium's statisticians and medical writers work directly from the study record, with every value traceable to the event that produced it, from the analysis plan through the clinical study report.
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Statistical Analysis Plan
The SAP authored to match the protocol exactly, with estimates, populations, and handling of missing data specified before the first analysis runs.
Statistical Programming
Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets, tables, listings, and figures produced to CDISC standards, with programs and outputs version-controlled and reproducible.
Sample Size & Randomization
Power calculations and randomization strategy defined at design and executed as specified, with allocation traceable to eligibility and consent.
Interim & Safety Analyses
Interim analyses, data safety monitoring board (DSMB) and safety monitoring outputs, and unblinding procedures executed under documented controls that preserve study integrity.
Clinical Study Report
ICH E3-structured CSRs written alongside the statistical outputs they describe, so narrative and numbers are reconciled as they are produced rather than at the end.
Regulatory & Scientific Writing
Protocols, protocol amendments, and clinical study reports, written by specialists fluent in both the science and the regulatory expectations of the receiving agency.
Analysis on Verified Data
Statisticians work from the event-driven audit log rather than an extracted copy. Every value carries its provenance, so a reviewer can trace any number in a table back to the moment it was captured.
Analyzed. Written. Submission-Ready.
Defensible results, delivered in documents regulators expect.
FAQs - Common Questions
Alethium provides statistical analysis plan authoring, sample size and power calculations, randomization strategy, statistical programming in SDTM and ADaM to CDISC standards, tables, listings and figures, interim and safety analyses, and data safety monitoring board support.
Yes. Statistical and medical writing services can be engaged independently, including for studies conducted on another CRO's systems or a sponsor's own EDC. Data are imported, validated, and analyzed under the same documented controls.
Yes. Data structures are CDISC-aligned from the design stage, so SDTM and ADaM datasets are produced by construction rather than remediated before submission. Define-XML and reviewer guides are delivered with the datasets.
Yes. Alethium produces ICH E3-structured clinical study reports, written alongside the statistical outputs they describe so narrative and numbers are reconciled during production rather than at the end. Alethium also authors protocols and protocol amendments.
Programs and outputs are version-controlled, and analysis runs against the study record rather than a manually extracted copy. Every value carries provenance back to the event that produced it, so any number in a table can be traced to the moment of capture, which is what a regulatory reviewer asks for first.