Biostatistics
Experienced Biostatistics and Statistical Programming Support
Ergomed offers a full range of biostatistical services for clinical trials across all phases, as well as noninterventional studies and retrospective data analyses. Our team of biostatisticians and statistical programmers has an average of 10 years of industry experience and has collectively worked on trials in most therapeutic areas, with specialist experience in oncology and rare diseases.
Comprehensive Biostatistical Services
Our biostatistics team adheres to stringent regulatory standards and international guidelines, ensuring that all aspects of clinical research are supported with precision and reliability. From initial statistical consulting and first-in-human studies to publication support and electronic Common Technical Document (eCTD)–compliant submission packages, our services are designed to meet the diverse needs of our clients. Our team is further bolstered by highly skilled Statistical Analysis System (SAS) programmers who provide robust analytical support throughout the research process, giving you the reassurance of high-quality, reliable support.
Statistical Consulting and Strategic Planning
We offer statistical consulting for complex statistical methodology and the implementation of adaptive designs. Our team can provide regulatory guidance for strategic planning, ensuring that all statistical analyses and methodologies align with regulatory expectations. Analyses and computations are conducted using industry-standard, validated software tools, guaranteeing the accuracy and integrity of the results. This ensures that you can trust the data and their insights.
Key Biostatistical Services Offered
Our expert biostatistics team provides a wide array of services, including but not limited to:
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We offer expert advice on designing studies to ensure robust and scientifically sound methodologies that meet regulatory requirements.
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Comprehensive analysis and detailed reporting of clinical trial data, ensuring clarity and accuracy in presenting results.
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Crafting detailed plans that outline the statistical methods and analyses to be employed, ensuring consistency and transparency in data handling as part of creating tables, figures, and listings.
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Precise calculations determine the appropriate sample size to achieve statistically significant results, enhancing the study’s credibility.
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Designing and implementing randomization schemes that reduce bias and ensure the integrity of the study.
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Authoring detailed and precise statistical sections to support the overall study protocol and final clinical study report.
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Creating comprehensive and informative tables, listings, and figures to communicate study findings effectively.
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Developing domains that are Clinical Data Interchange Standards Consortium (CDISC) compliant using Study Data Tabulation Models (SDTM) and Analysis Data Models (ADaM), with complete documentation and validation.
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Providing statistical support to ensure ongoing safety and efficacy monitoring throughout the trial.
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Conducting detailed pharmacokinetic and pharmacodynamic analyses to understand drug behavior and effects.
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Supporting risk-based monitoring activities to enhance the efficiency and effectiveness of clinical trial oversight.
Ergomed’s Commitment to Excellence
At Ergomed, our unwavering commitment to excellence in biostatistics ensures that your clinical trial data are handled with the utmost care and precision. Our comprehensive services and personalized approach make us the ideal partner for your clinical trial biostatistics needs. We stand out from our competitors with our deep understanding of the regulatory landscape, our ability to provide strategic guidance, and our commitment to delivering high-quality, reliable data.
Partner with Ergomed to gain access to a team dedicated to delivering the highest standards of biostatistical support tailored to meet the unique needs of your clinical study.
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