Clinical trial data is the foundation of drug development, and a poorly designed study can jeopardize even the most promising therapies. Certara’s expert biostatistics consulting team ensures high-quality data collection, validation, and analysis, enabling smarter decisions and reducing risks. With comprehensive support across all phases of drug development, we help you conduct efficient and cost-effective trials in a way that increases the odds of regulatory approval.
Biostatistics & Statistical Programming
Biostatistics and Statistical Programming Services
Certara’s biostatistics consulting services and SDTM & ADaM dataset programming services are designed to improve clinical trial performance in all phases of drug development and streamline decision-making processes.
Learn more about Biostatistics and Statistical Programming
Advanced biostatistics consulting and CDISC-compliant statistical programming
Proficient in advanced methods
Our team excels in advanced statistical methodologies and adaptive clinical trial designs to modernize the delivery of biometrics consulting.
Integrated, end-to-end support
Capabilities covering all phases of drug development that closely link with pharmacometrics, clinical pharmacology, and regulatory solutions.
CDISC-compliant programming
Optimize your clinical trials with SDTM & ADaM dataset programming services, ensuring compliance and streamlined submissions.
Technology-enabled services
Harness the power of proprietary data management platforms like Pinnacle 21 and SEND Explorer in combination with biostatistical expertise for greater standardization and streamlined submissions.
Why choose Certara for biostatistics consulting?
Certara combines decades of expertise with innovative methodologies to deliver unparalleled biostatistical and statistical programming services.
我们的服务方案
Biostatistics consulting
Expert support for all phases of drug development.
Protocol development
Study design, power and sample size calculations, statistical analysis plan summary and protocol review and writing
Study implementation
Statistical analysis plan (SAP), TLF shells, dataset and data transfer specifications and project management
Data management services
Ensure accuracy with clinical data management oversight.
Study monitoring
Data and safety monitoring boards (DSMB), interim analysis and data quality risk control
Reporting
Integrated summaries of safety and efficacy (ISS/ISE), clinical study report (CSR) and CDISC define.xml and other e-submission components
SEND dataset programming
CDISC-compliant SEND datasets for FDA submissions.
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专家
Ragini Hari
Senior Director, Biostatistics
Ragini 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 leaders...
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专家
Thomas Peppard, MS
Senior Director, Biostatistics
Tom brings 20+ years’ experience and expertise in Phase 1-3 pharmaceutical research. At Certara, he develops and executes SAPs, advises on clinical trial design and simulation, and consults on data-driven decision making for pharmaceutical and biotech clients globally. He’s proficient across a range of trial designs and analyses including bio...
建立联系Why choose Certara for biostatistics consulting?
Certara’s biostatistics consulting services stand out for their technical precision, regulatory expertise, and commitment to innovation. Our integrated approach ensures success from study design to regulatory submission, helping you achieve faster approvals and better outcomes.
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Partnering with Certara means accessing advanced biostatistics consulting services and CDISC-compliant programming solutions. Our proven expertise ensures your trials are efficient, accurate, and aligned with regulatory standards.
Why contact Certara?
Access to leading experts in biostatistics and statistical programming.
Comprehensive support across all clinical trial phases.
Proven track record of successful regulatory submissions.
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常见问题解答
What is biostatistics consulting?
It involves expert support for study design, data analysis, and regulatory submissions to improve clinical trial outcomes.
什么是 SDTM 和 ADaM 数据集？
These are CDISC-compliant data formats required for regulatory submissions.
What is CDISC-compliant programming?
It ensures datasets meet global submission standards, streamlining the approval process.
