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Statistics & Statistical Programming

Clinical Trials >> Technology / Data / Analytics >> Clinical Biostatistics and Programming

Protocol input, sample size calculation and randomization, Statistical Analysis Plan and formal statistical analysis/interpretation, Program/QC study listings, tables and figures using SAS, Program/QC CDISC datasets (SDTM and ADaM) using SAS, Define.xml.

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Pharmacokinetic Analysis Using Phoenix WinNonlin

Clinical Trials >> Technology / Data / Analytics >> Clinical Biostatistics and Programming

Rapid interim PK turnaround times for formulation decisions or SAD/MAD safety evaluation, Modeling and simulation using GastroPlus, including development of IVIVCs

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Statistics, Pharmacokinetics & Scintigraphy

Clinical Trials >> Technology / Data / Analytics >> Clinical Biostatistics and Programming

Our statistical, pharmacokinetic and scintigraphic experts understand clinical pharmacology studies and their specialized challenges. Optimize your study objectives, design and subject numbers, and maximize your use of study data:

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Integrated Summary of Efficacy (ISE)

Clinical Trials >> Technology / Data / Analytics >> Clinical Biostatistics and Programming

Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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Integrated Safety Summary (ISS) 

Clinical Trials >> Technology / Data / Analytics >> Clinical Biostatistics and Programming

Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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ADaMs (Analysis Data Model) CDISC Compliant Format

Clinical Trials >> Technology / Data / Analytics >> Clinical Biostatistics and Programming

Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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Statistical Analysis Plan Development

Clinical Trials >> Technology / Data / Analytics >> Clinical Biostatistics and Programming

Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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Interim Analyses

Clinical Trials >> Technology / Data / Analytics >> Clinical Biostatistics and Programming

Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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Statistical Support

Clinical Trials >> Technology / Data / Analytics >> Clinical Biostatistics and Programming

Our statisticians develop statistical analysis plans, which reflect study goals and closely follow the ICH guidelines for the design of case report forms (CRFs), database structure, data plausibility checks, and quality control procedures as well as choice of study objectives, sample size calculation,

Clinical biostatistics and statistical programming excellence across all phases of drug development in a wide range of therapeutic areas. Biostatistics comprehensive services include: Input to Study Design (including adaptive designs) and sample size calculation, SAP, mock tables and LoT, Guidance to programmers and review of TLGs (tables, listings, graphs), Statistical report and input to CSR, Response to requests and queries from regulators, Pharmacometric and Pharmacodynamic analysis and modelling, Interim analysis and support to data and safety monitoring boards (DSMBs), Exploratory analyses for publications, abstracts, and marketing, including meta analysis. Statistical Programming comprehensive services include: Inputs into statistical analysis plan and creations of mock shells, Develop Study Data Tabulation Model (SDTM) datasets and Analysis Data Model (ADaM) datasets and define.xml, Develop programming Specifications, analysis datasets and Tables, listings and figures (TLFs) for safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD) endpoints, Programming support for Clinical Study Report (CSR), Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE) submissions and various other submissions during conduct of clinical trials, Ad-hoc programming for support of Statistics, Clinical Operations, Data Management and Regulatory functions, Develop Patient Profiles and In-text Tables, Support Interim analysis, Data Monitoring Committee meetings, Database lock related activities and regulatory submissions activities, Data conversion, migration, legacy to standard or SDTM mapping and conversion between different standards, Develop customized solutions for process standardization for clients and building standard macros as per client requirements. Biostatisticians have a desire for quality and implement the best approach to a client situation/scenario to ensure correct analysis without an over complex process using the appropriate tools to demonstrate the efficacy of a drug and present the results in the clearest way possible. Statistical consultancy services focus on protocol design, calculation of sample sizes, power calculations, and/or the production of a study randomization. Clinical Biostatistics Services include: Pre-Clinical Studies support and advice for pre-clinical studies to ensure the study objective is being fulfilled. Protocol Input which includes clinical study design, sample size calculations and consultancy advice during the start up of a study, production of randomizations or Unblinding including production of emergency unblinding envelopes, Statistical Analysis Plan (SAP) and Output Shells optimizing the use of our Consultant Statisticians to ensure innovative approaches to the statistical content of a study to increase the chances of a successful trial, clinical Data Interchange Standards Consortium (CDISC) use ensures that the data used in the outputs produced complies with regulatory standards, Output Production ensures increased efficiency when producing outputs, modeling the relationship between exposure and response using nonliner models and non-linear mixed effect modelling under PK/PD Analysis, production of Statistical Report/Clinical Study Report, Interim Analysis/Data Safety Monitoring Boards (DSMBs), Meta Analysis, ISS/ISE support for the integration of safety and efficacy data prior to regulatory approval. Complete, Concise Biostatistics Reporting: Based on a well-developed plan, the statistical analysis implementation provides clients with timely, high-quality deliverables through a centralized computing platform that unifies global biostatisticians and programmers, increasing productivity, saving time and enhancing data security. Analysis strategies that are International Conference on Harmonisation compliant, production of audit-ready tables, listings and figures, new drug application (NDA) submission-ready data delivery in Clinical Data Interchange Standards Consortium (CDISC) format, integrated submissions of statistical sections, data and safety monitoring board (DSMB) output, interim analysis and investigational new drug (IND) safety updates, development of comprehensive methods reports describing planned and exploratory analyses, collaboration with medical writers and clinical scientists to ensure appropriate interpretation of quantitative results, support for manuscripts and abstracts, expert Statistical Analysis, Clinical Biostatistics Services, Software Solutions, CDISC Compliant Format Analysis Data Model Biostatistics, Statistical Programming, Data Analytics & Epidemiology, Statistical Programming, Integrated Summary of Efficacy (ISE), Statistical Support, Data Analytics, Pharmacokinetic Analysis, Statistics, Pharmacokinetics & Scintigraphy, Statistical Consulting & Trial Designs, Interim Analyses, Statistical Analysis Plan Development, Sample size calculations Treatment randomization

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