Ensure regulatory compliance with biostatistical support for clinical trials.
Biostatistics are essential for any clinical development program, requiring accurate interpretation of clinical data. Businesses need to think creatively about study design to optimize outcomes and succeed in highly competitive, regulated markets.
Unrivaled biostatistical support
We offer a comprehensive range of solutions to support the collection, interpretation and presentation of biostatistical data. Utilizing our library of over 60 validated SAS macros and compliance between the used Study Data Tabulation Model (SDTM) and our in-house Analysis Data Model (ADaM) principle of harmonization, delivers high-quality analysis within short timelines. Our experts also provide guidance for all trial types, ensuring safety, efficacy and regulatory compliance.
- Design and sample size calculations for all clinical trials, including protocol reviews and co-authoring
- Adaptive trial designs support
- (e)CRF design input
- Analysis of all types of data – from pre-clinical, and clinical trials to epidemiological trials, following a variety of designs respecting the Statistical Analysis Plan (SAP) and mock Tables Listings Figures (TLFs)
- Programming of Clinical Data Interchange Standards Consortium (CDISC) ADaM datasets, TLFs and metadata, ready for inclusion in the electronic Common Technical Document (eCTD)
- Interim analyses and defining stopping rules, including an independent statistician for unblinded interim analyses
- Pooling of studies, including safety and efficacy summaries for regulatory submissions
- Independent statistician participating in the Data Monitoring Committee (DMC) board and/or generation of the DMC analysis
- CSR review and programming of case narratives/patient profiles
- Client preparation for results presentations to the FDA and EMA
Why choose SGS?
We are recognized as the benchmark for quality and integrity in clinical research. Our experts support you throughout the trial process, ensuring continuity and flexibility in study deliverables and enabling you to achieve the full potential from your data.
Volcán 150, Piso 5,
Col. Lomas de Chapultepec Tercera Sección, 11000,
Miguel Hidalgo, Mexico City, Mexico