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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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Celerion

Chiltern International Ltd

DZS Clinical Services

ICBio Clinical Research Pvt Ltd

KAI Research

MPI Research Inc

Mapi Group

Navitas Inc

Nutrasource

PAREXEL International Corporation

PHA Farmed d.o.o

Pharmaceutical Product Development, LLC

Quotient Sciences

Spaulding Clinical, LLC

TFS International AB

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INDIA

SLOVENIA

SWEDEN

UNITED KINGDOM

UNITED STATES

Virtual BoothTransforming Drug Development with Science & Innovation.

Statistics & Statistical Programming

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We perform Statistics & Statistical Programming including sample size calculation & randomization, Statistical Analysis Plan, Interpretation, tables, figures using SAS, Program/QC CDISC datasets using SAS, Define.xml & related documentation.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

Virtual BoothTransforming Drug Development with Science & Innovation.

Statistics, Pharmacokinetics & Scintigraphy

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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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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Supporting All Phases of Drug Development

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MPI Research is a full early-stage drug development CRO that partners with biopharmaceutical, biotechnology, medical device, animal health, and chemical industries to advance global healthcare. MPI Research supports all phases of the drug development pathway, ranging from target identification

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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ClinPlus® eClinical Software

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Leveraging our industry-leading ClinPlus® eClinical software platform to manage the trial, ensure data accuracy and implement smart, proprietary algorithms to identify and mitigate risk

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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PK Analysis Using Phoenix WinNonlin

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We perform 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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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Biostatistics & Statistical Programming

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Chiltern’s biostatistics and statistical programming team provides operational and strategic statistics for clinical research and development. Our operational expertise allows us to deliver the high-quality statistical output required for every aspect of drug development including the statistical

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Statistical Support

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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,

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Biostatistics

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Celerion’s statisticians are intricately involved in study design, CRF design, data import/export and data cleaning and review and are often consulted to perform special calculations and summarizations of information for non-study-related issues for problem solving and process improvement.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Clinical Biostatistics Services

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PPD’s global clinical biostatistics and programming team offers more than statistical analyses. We bring a deep understanding of the science of disease and compounds, as well as provide valuable upfront study design and comprehensive planning assistance.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Data Analytics & Epidemiology

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All of Mapi’s epidemiologists, outcomes research scientists, and analysts are trained in the art and the science of robust literature reviews; whether clients need a simple (and rapid) safety review, structured or systematic literature review, or full meta-analysis, Mapi’s team delivers

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Biostatistics Support & Statistical Programmi...

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Our statisticians have decades of industry experience providing prompt and accurate reports, statistical summaries and efficacy and safety analyses. From the initial stage of study design planning to final stages of data analysis and interpretation, it’s easy with DZS.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Biostatistical Services

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Unlike other CROs that often provide a one-size-fits-all approach to statistical analysis, Nutrasource offers a flexible approach to biostatistics driven by your clinical research goals.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Sample Size Calculations

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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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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Treatment Randomization 

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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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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Biostatistics & Statistical Programming

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Chiltern’s industry-leading team of data management professionals and statisticians is one of the largest in the industry. With real-world experience in adaptive trial designs and the latest data analytics platforms and technologies, we make certain you can not only access, but also examine

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Statistical Analysis Plan Development

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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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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Interim Analyses

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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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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Statistical Consulting & Trial Designs

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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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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Summary Tables, Listings & Figures & Listings...

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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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Integrated Safety Summary (ISS) 

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Biostatistics

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- Service Details

The Biostatistics unit consists of a team of experienced biostatisticians and SAS programmers managing all the statistical activities related to clinical trials.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Integrated Summary of Efficacy (ISE)

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Data Analytics

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- Service Details

Assisting biopharmaceutical companies position the comparative value of products, therapies, and portfolios, we provide a full continuum of data analytic services from tabular reports to multivariate statistical modeling, all in support of your commercial decision making.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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ADaMs (Analysis Data Model) CDISC Compliant F...

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- Service Details

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.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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OneClinical

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Navitas Life Sciences’ Optimized eClinical and Analytics Platform Offering Comprehensive Trial Oversight and Enabling Faster Decisions.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Clinical Biostatistics and Programming

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- Service Details

Our bio statistics for clinical research & statistical programming services include pre-analysis & post-analysis. Our bio-statisticians help you navigate the complexities of study design, sample size, analysis methods, data displays & interpretations.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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Clinical Biostatistics

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- Service Details

We bring into the business the experienced professionals and managing partners who possess the necessary expertise to provide the conditions which are obligatory to accelerate the continuous development and to achieve the added value for our customers.

- Directory Listing

Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Clinical Biostatistics and Programming

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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