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At Galaxbiotech Solutions, our biostatistics and programming experts transform your raw trial data into compelling, well-supported evidence. By integrating rigorous statistical methods with specialized therapeutic knowledge, we design studies, define meaningful endpoints, and select the most appropriate analyses from the outset.
Using SAS and/or LUP Analytics, we develop ADaM-compliant analysis datasets and deliver a comprehensive TLF package—reusable across studies and programs. Each step is meticulously documented, validated, and aligned with global regulatory standards. From the initial protocol draft to the final Clinical Study Report (CSR) and submission, we prioritize transparency, reproducibility, and efficiency to meet your timelines.
We partner with you from the initial phases of protocol development, turning your clinical questions into strong, well-structured statistical designs. Our biostatisticians assess various design options—such as parallel-group, crossover, adaptive, and dose-escalation studies—and guide you toward the best approach based on your goals and limitations.
Using proven methods, we determine the required sample size by making realistic assumptions about variability, effect size, and participant dropout. We also provide transparent justifications to satisfy regulatory and ethical requirements.
Throughout the process, we collaborate closely with your clinical and medical teams to ensure that every design decision is scientifically rigorous, operationally practical, and cost-effective.
A well-defined Statistical Analysis Plan (SAP) is essential for delivering trustworthy results. Our team develops detailed SAPs that clearly outline analysis populations, approaches for missing data, covariates, interim analyses, multiplicity adjustments, and sensitivity assessments.
To ensure clarity and consistency, we also create detailed mock shells for tables, listings, and figures—so all stakeholders visualize the final outputs before the first participant is even enrolled. This proactive approach minimizes ambiguity, aligns teams (clinical, medical writing, regulatory, and safety), and ensures everyone operates from the same blueprint.
Any revisions during the study are version-controlled and fully traceable, keeping your project inspection-ready at every stage.
Our programming team uses a standardized conversion process to transform raw data and EDC exports into SDTM and ADaM datasets, strictly following CDISC IG guidelines, controlled terminology, and your organization’s specific conventions. This ensures consistency across all studies.
Every derivation is thoroughly documented, with clear specifications tracing each variable back to its source and logic—streamlining reviews for both internal teams and external auditors. ADaM datasets are designed to directly support the analyses outlined in your Statistical Analysis Plan (SAP), including complex models like time-to-event, longitudinal, and multiplicity-adjusted analyses.
By prioritizing a standards-first approach, we simplify integration with LUP Analytics or other statistical platforms and minimize rework during regulatory submissions.
Using SDTM and ADaM as the foundation, we develop the complete suite of tables, listings, and figures required for safety, efficacy, and PK/PD endpoints. Our team adheres to rigorous programming and validation standards, including independent double-programming for critical outputs and automated quality checks to ensure accuracy.
To maintain consistency and efficiency, we leverage reusable macros and templates, reducing turnaround time for future projects. Outputs are delivered in multiple formats—SAS datasets, RTF/Word-ready files, Excel for sponsor review, and PDF for archiving—to meet your needs.
With robust automation, we seamlessly accommodate last-minute protocol changes or additional analyses, ensuring high quality and on-time delivery.
Beyond standard efficacy and safety reporting, we specialize in advanced analytical methods, including:
Every specialized analysis is fully traceable to source data, with transparent documentation of assumptions and model selections. Our graphical outputs are crafted to clearly convey complex patterns to clinicians, regulators, and internal stakeholders.
By integrating clinical, PK, and biomarker data, we provide a comprehensive view of treatment effects, empowering you to make informed decisions and refine your development strategy.
At study completion, we deliver comprehensive statistical packages to support your Clinical Study Report (CSR) and pooled analyses like ISS/ISE. This includes:
Our statisticians work hand-in-hand with medical writers to ensure text, tables, and figures align seamlessly, accurately reflecting all SAP-specified analyses. We also provide expert support for health authority queries, ad-hoc analyses, and advisory board presentations, ensuring your data meets the highest standards of scrutiny.