Analytical Support for non-clinical and clinical datasets
Data generated from clinical trials are at the heart of drug development. Even a potentially life saving drug will fail in a poorly designed study if the data collected is not properly collected, validated and analyzed. Engaging early and often with an expert biostatistics consulting team can help you make smarter decisions over the duration of your program and reduce the risk of conducting studies that produce unreliable, poor quality data yielding unintepretable results.
Certara’s global team of biostatisticians and statistical programmers offer comprehensive support services for preclincal data and in all phases of drug development. Our expertise culminates from a deep understanding of data, study design and regulatory requirements. Consequently, we also support post-approval regulatory commitments, regulatory responses for statistical questions, regulatory briefing book preparation, and face-to-face regulatory meetings. 此外，该团队在与医学专家以及关键意见领袖合作以提供出版支持方面拥有丰富的经验。By working with Certara biostatisticians, you can help ensure that your clinical trials are conducted in most efficient and cost-effective way and maximize the chances for regulatory approval.
Biostatistics Consulting and Analysis
Our highly experienced team of biostatisticians have extensive experience supporting all phases of drug development and offer a wide range of services, including:
- Statistical input to Clinical Development Plan (CDP), Target Product Profile (TPP)
- 研究设计，包括功率和样本量计算，以及方案的统计部分
- 研究设计，包括功率和样本量计算，以及方案的统计部分
- Adaptive Statistical Methods, including Bayesian Analysis
- Development of Statistical Analysis Plan (SAP) and Table, Listing, and Figure (TLF) shells
- 撰写和审查临床研究报告
- Data Monitoring Committee and Data Safety Monitoring Boards (DMC/DSMB) support
- Independent Statistical Data Analysis Center (iSDAC): DMC Charter, SAP development/authoring, blinded/unblinded DMC report production
- Secure Data Office (SDO): hub for the control of unblinding data streams
- 监管支持包括
- ISS/ISE/ISI production
- Submission consulting, including support for Health Authorities requests
- FDA 咨询委员会小组支持
- 为 FDA 或全球监管会议提供统计资料，包括简报手册
CDISC-Compliant Statistical Programming Services for SDTM and ADaM Datasets
我们经验丰富的统计编程团队为药物开发的各个阶段提供支持，并提供以下服务：
- 来自各方的数据传输：申办方、CROs、中心实验室等。
- SDTM Dataset programming
- ADaM 数据集编程
- TLF 编程
- 审查数据的一致性和科学完整性
- 支持 DSMB/DMC 的产出
- 提交就绪的数据交付，包括 SDTM 和 ADaM Define.XML、审稿人指南和Pinnacle 21E 检查。
Clinical Data Management and Oversight to Ensure Success and Accuracy throughout your Trial
Certara’s clinical data management and oversight services include:
- 管理用于电子化病历报告表（eCRF）构建和数据管理的供应商
- 为 eCRF 的设计和开发做出贡献
- Perform User Acceptance Testing to ensure that the Electronic Data Capture (EDC) system fulfils the requirements for a clinical study
- 审查数据管理文件，如数据管理计划、数据验证手册、eCRF 完成指南、编辑检查规范等
SEND Dataset Programming Services for Non-Clinical Data
Certara’s biostatistical programming team offers preparation of submission-ready, CDISC compliant SEND dataset packages. Flexible delivery timelines are available for SEND dataset packages and supporting documentation required to support SEND FDA IND and IND submissions, as well as legacy SEND conversion projects.
- Generate SEND dataset packages using SAS programming
- Run validation through Pinnacle 21 software to ensure submission compliance
- QC review of SEND datasets for all studies and review work by third-party organizations like CROs to ensure data integrity and submission quality
我们的专家
Ragini Hari Senior Director, Biostatistics
Thomas Peppard, MS Senior Director, Biostatistics
Ragini Hari Senior Director, Biostatistics
Thomas Peppard, MS Senior Director, Biostatistics
Ragini is a Senior Director of Biostatistics at Certara. She has 20+ years’ experience in the fields of statistical programming, biometrics and data management in the pharmaceutical industry. She’s led multiple complex submissions to the FDA, EMEA and PMDA, and has demonstrated expertise in CDISC and regulatory submissions throughout her career. Prior to joining Certara, she held various leadership positions at Cytel, ICON, PPD and Covance. Ragini also serves as the Co-Vice Chair for Women in Bio.
Thomas E. Peppard has a Master’s degree in Statistics and over two decades of expertise in Phase 1-3 pharmaceutical research. Currently serving as a Senior Director of Biostatistics at Certara, Tom develops and executes statistical analysis plans, advises on clinical trial design and simulation, and consults on data-driven decision-making for pharmaceutical and biotechnology clients globally. Tom has experience across a range of therapy areas including infectious disease, maternal and neonatal health, cardiovascular disease, pulmonary disease and inflammatory disease, and he has experience across a range of trial designs and analyses including bioequivalence, crossover, non-inferiority and cluster randomized designs. Tom is a certified Advanced Programmer in SAS and is a proficient R programmer, including R/tidyverse.
Ragini is a Senior Director of Biostatistics at Certara. She has 20+ years’ experience in the fields of statistical programming, biometrics and data management in the pharmaceutical industry. She’s led multiple complex submissions to the FDA, EMEA and PMDA, and has demonstrated expertise in CDISC and regulatory submissions throughout her career. Prior to joining Certara, she held various leadership positions at Cytel, ICON, PPD and Covance. Ragini also serves as the Co-Vice Chair for Women in Bio.
Thomas E. Peppard has a Master’s degree in Statistics and over two decades of expertise in Phase 1-3 pharmaceutical research. Currently serving as a Senior Director of Biostatistics at Certara, Tom develops and executes statistical analysis plans, advises on clinical trial design and simulation, and consults on data-driven decision-making for pharmaceutical and biotechnology clients globally. Tom has experience across a range of therapy areas including infectious disease, maternal and neonatal health, cardiovascular disease, pulmonary disease and inflammatory disease, and he has experience across a range of trial designs and analyses including bioequivalence, crossover, non-inferiority and cluster randomized designs. Tom is a certified Advanced Programmer in SAS and is a proficient R programmer, including R/tidyverse.
