The professionals behind Novastatix bring extensive project experience across CDISC, pharmaceutical statistics, biostatistics, bioequivalence, regulatory support and healthcare technology.
Our available project records demonstrate substantial delivery volume in CDISC and specialized pharmaceutical statistics, supported by broader experience in biostatistics, bioequivalence, regulatory response and technology development.
SDTM, ADaM, legacy migration, metadata, validation and submission support.
Specialized statistical analyses supporting formulation, product development and regulatory requirements.
Average and Population Bioequivalence assignments, including particle-size applications.
Classical f2, bootstrap f2 and related dissolution-profile assessments.
Across our team’s prior delivery history, CDISC work has included study-level development, legacy-data migration, standards conversion, remediation and submission support. Project activities have covered SDTM and ADaM development, mapping specifications, traceable derivations, annotated CRFs, Define-XML, Study Data Reviewer’s Guides, Analysis Data Reviewer’s Guides, controlled terminology, Pinnacle 21 validation and remediation, XPT preparation and submission-readiness review.
The experience includes first-time standardization of raw or legacy study data as well as remediation and standards-version upgrades of existing packages. Work has been performed across individual studies and broader development programs requiring consistent standards, metadata and traceability.
Our documented pharmaceutical-statistics experience includes more than 200 assignments supporting formulation development, product comparison and regulatory requirements. The work includes Average Bioequivalence (ABE), Population Bioequivalence (PBE), particle-size distribution analyses, classical f1/f2 and bootstrap f2, dissolution-profile comparison, confidence-limit approaches, stability and shelf-life analysis, formulation and batch comparisons, and additional statistical analyses in response to sponsor or regulatory questions.
Regulatory and agency-query support is documented across both PBE and dissolution/f2 work and is presented as overlapping project support rather than as an additional project count.
The following examples describe the types of assignments delivered across prior roles and organizations. Client names, protocol identifiers and confidential product details remain anonymized unless Novastatix has explicit permission to publish them.
Transformation of raw or legacy clinical data into SDTM and ADaM; development of mapping and derivation specifications; metadata and reviewer documentation; Pinnacle 21 validation, remediation and submission-package preparation.
Average and Population Bioequivalence analyses supporting particle-size comparisons, including statistical evaluation of metrics such as D50, SPAN, PDI and Z-Average, together with supporting reports and additional analyses where required.
Classical f1/f2, bootstrap f2 and related confidence-limit approaches for dissolution-profile comparison across strengths, media and time points, including additional analyses supporting sponsor or agency questions.
Statistical support for fasting/fed, crossover, parallel and replicate bioequivalence programs, including PK parameter analysis, geometric mean ratios and 90% confidence intervals, descriptive PK summaries and study TLFs.
Protocol and statistical-design input, sample-size calculation, randomization, SAP development, efficacy and safety analyses, interim-analysis support, DMC/DSMB outputs, integrated analyses and statistical input to clinical study reports.
Additional analyses, reanalysis, updated statistical outputs and technical responses to sponsor and regulatory-review questions, including documented work in PBE and dissolution/f2 programs.
Prior technology delivery includes an end-to-end interactive 3D application for ceiling and wall medical supply units. The application enabled users to virtually simulate and configure equipment according to client requirements, select components and options, and generate downstream commercial outputs including proposals, bills of materials, quotations and final invoices. This experience supports Novastatix’s broader capability in custom healthcare, medical-device visualization, BI/KPI and workflow-automation solutions.
If your program requires CDISC development or migration, specialized pharmaceutical statistics, biostatistics, regulatory-support analyses or a purpose-built healthcare technology solution, talk to us about the scope and delivery model that fits your project.
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