Generated by All in One SEO Pro v4.9.10, this is an llms.txt file, used by LLMs to index the site. # Stat One Expert Statistical Consulting | Your Partner in Growing a Better Future ## Sitemaps - [XML Sitemap](https://www.statonellc.com/sitemap.xml): Contains all public & indexable URLs for this website. ## Posts - [Articles](https://www.statonellc.com/articles/) - Stay informed with Stat One's latest industry trends and insights through articles and infographics of the clinical trial industry. - [Stat One's George DeMuth Listed as Author in Current Oncology](https://www.statonellc.com/stat-ones-george-demuth-listed-as-author-in-current-oncology/) - Click here to read a recent article in Current Oncology where George DeMuth with Stat One is listed as an author: https://www.mdpi.com/1718-7729/32/11/638. - [Improving Your Clinical Programs with Stat One's Support](https://www.statonellc.com/improving-your-clinical-programs-with-stat-ones-support/) - With a rich history and a strong commitment to quality, Stat One is an excellent choice for those looking to advance healthcare and medicine. - [INTRODUCING STAT ONE EDC®](https://www.statonellc.com/introducing-stat-one-edc/) - Built on years of expertise in analyzing data and supporting clinical trials, Stat One EDC® brings you advanced features that streamline your clinical programs. - [The Cost-Benefit Analysis of Engaging Statistical Experts](https://www.statonellc.com/the-cost-benefit-analysis-of-engaging-statistical-experts/) - With a focus on both data quality and expert statistics, Stat One is your statistical expert for your clinical programs and successful FDA approval. - [STAT ONE: EFFECTIVE COLLABORATION FOR FDA APPROVAL](https://www.statonellc.com/effective-collaboration-for-fda-approval/) - Stat One emphasizes establishing and maintaining effective and early collaboration in achieving a successful and efficient FDA approval process. - [Key Importance of Sample Size Calculation](https://www.statonellc.com/the-importance-of-a-sample-size-calculation/) - Stat One reports on the importance of sample size in obtaining compelling or statistically significant results. - [42nd Annual J.P. Morgan Healthcare Conference](https://www.statonellc.com/42nd-annual-j-p-morgan-healthcare-conference/) - Stat One, a specialty Contract Research Organization (CRO), looks forward to attending the 42nd Annual J.P. Morgan Healthcare Conference. - [STAT ONE: YOUR TRUSTED PARTNER IN CARDIOVASCULAR TRIALS](https://www.statonellc.com/stat-one-your-trusted-partner-in-cardiovascular-trials/) - Stat One is a specialty Contract Research Organization (CRO) providing expert statistics, programming, and data management services for cardiovascular trials. - [Keys to Selecting an EDC System](https://www.statonellc.com/keys-to-selecting-an-edc-system/) - Selecting an EDC (Electronic Data Capture) System is a very important decision. Stat One is outlining the important elements to consider and why they matter. - [Stat One: Clinical Research & Product Development in 2023](https://www.statonellc.com/stat-one-clinical-research-product-development-in-2023/) - As the healthcare industry enters a new era, Stat One looks forward to being a part of the continued innovation in clinical research and contributing to growth. - [CDRH Launches the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot](https://www.statonellc.com/cdrh-launches-the-total-product-life-cycle-tplc-advisory-program-tap-pilot/) - The FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. - [FDA Guidance Adjusting for Covariates in Randomized Trials](https://www.statonellc.com/fda-guidance-adjusting-for-covariates-in-randomized-trials/) - In this guidance, the FDA discusses how to adjust for covariates in statistical analyses in randomized clinical trials in drug development programs. - [TCT 2022 Key Takeaways](https://www.statonellc.com/tct-keytakeaways/) - Recent key takeaways from the TCT 2022 Conference and cardiovascular research innovations. - [FDA Guidance RWD and RWE](https://www.statonellc.com/fda-guidance-rwd-rwe/) - To manage tracking of submissions that include real-world data (RWD) and real-world evidence (RWE), the FDA has released a final guidance asking for identification of such data. - [COVID-19: Impact Visual Guide](https://www.statonellc.com/covid-19-impact-visual-guide/) - COVID-19: Impact Visual Guide | An impact visual guide outlining the impact of COVID-19 and the factors affecting conduct of clinical trials. - [Stat One: A Medical Device Specialty Group](https://www.statonellc.com/stat-one-a-medical-device-specialty-group/) - [Conduct of Clinical Trials During COVID-19](https://www.statonellc.com/conduct-of-clinical-trials-during-covid-19/) - To address the impact of the COVID-19 pandemic on the conduct of clinical trials, the FDA has provided considerations through a guidance document. - [We are hiring a Statistician!](https://www.statonellc.com/we-are-hiring-a-statistician/) - We're hiring a statistician! Please contact us if you're interested in joining our Team. - [Traditional Values, New Technologies](https://www.statonellc.com/traditional-values-new-technologies/) - Traditional Value, New Technologies | Stat One has started the New Year off with much excitement offering expert statistical services. - [Challenges and Opportunities in Clinical Trials](https://www.statonellc.com/challenges-and-opportunities-in-clinical-trials/) - The clinical trials industry seems to offer challenges and opportunities configured at the confluence of good science, experienced leaders, and solid funding. - [Paper: Considerations On The Use Of Adaptive Designs in Clinical Trials](https://www.statonellc.com/paper-considerations-on-the-use-of-adaptive-designs-in-clinical-trials/) - [CRO Industry: The Importance of Business Practices and Client Relationships](https://www.statonellc.com/cro-industry-the-importance-of-business-practices-and-client-relationships/) - CRO | In a relationship-driven industry, teams at contract research organizations (CROs) and consultants may have practices that differ from company to company. - [Important Aspects to Consider When Choosing an EDC System](https://www.statonellc.com/important-aspects-to-consider-when-choosing-an-edc-system/) - This Stat One article highlights important aspects to consider when selecting an EDC system and outlines the factors that make up the data capture market. - [Stat One: New Office Opening](https://www.statonellc.com/stat-one-new-office-opening/) - Stat One CRO announces their new office opening in Research Triangle Park. - [Stat One EDC®: Balance](https://www.statonellc.com/stat-one-edc-balance/) - Stat One EDC® provides balance and efficiency. Stat One believes that the choice of a data capture solution can be a crucial decision. - [FDA releases Artificial Intelligence Action Plan](https://www.statonellc.com/fda-releases-artificial-intelligence-action-plan/) - As the healthcare industry continues to transform through Artificial Intelligence products, the FDA has released an Artificial Intelligence Plan. - [Clinical Development Capabilities](https://www.statonellc.com/clinical-development-capabilities/) - Clinical Development Capabilities with Stat One CRO who is dedicated to providing high-quality services and statistical expertise for your clinical programs. - [U.S. FDA: COVID-19 Update](https://www.statonellc.com/u-s-fda-covid-19-update/) - U.S. FDA: COVID-19 Update has been continuously monitored throughout the pandemic. The latest update from the FDA outlines their efforts. - [COVID-19: Factors Affecting Conduct of Clinical Trials](https://www.statonellc.com/covid-19-factors-affecting-conduct-of-clinical-trials/) - As clinical programs face challenges following the COVID-19, companies have continued to adapt to the impact and affect on clinical trials. - [Critical Factors in the Development Process of Diagnostics](https://www.statonellc.com/critical-factors-in-the-development-process-of-diagnostics/) - Critical Factors in the Development Process of Diagnostics | An outline of critical factors to consider in medical tech & the development process of diagnostics - [Understanding FDA Study Data Standards](https://www.statonellc.com/understanding-fda-study-data-standards-2/) - The FDA has study data standards to enhance the efficiency of the submission process. These standards provide a consistent framework for organizing study data. - [The Importance of a Biostatistician in Clinical Trials](https://www.statonellc.com/the-importance-of-a-biostatistician-in-clinical-trials-2/) - Biostatisticians play a crucial role when bringing a new product to market. Their role includes much more than analyzing data at the end of a clinical study. - [CEO: George DeMuth, Statistical Expert](https://www.statonellc.com/ceo-george-demuth-statistical-expert/) - CEO: George DeMuth, Statistical Expert, has over 30 years of experience and has worked with hundreds of clients and helped obtain regulatory approval. - [Stat One CEO: Journal Of Pathology](https://www.statonellc.com/stat-one-ceo-journal-of-pathology/) - CEO of Stat One, George DeMuth, was an author in a Journal of Pathology Paper. Mr. DeMuth performed the statistical analysis for the study. ## Pages - [Stat One CRO | Contract Research Organization](https://www.statonellc.com/) - Stat One is a CRO (contract research organization) supporting clinical trials for pharmaceutical, biotechnology, and medical device companies. - [Stat One EDC®](https://www.statonellc.com/stat-one-edc/) - Stat One is committed to helping companies achieve FDA approval. Through regulatory navigation and expert statistical support, Stat One is laser focused in their services. - [eClinical Solutions](https://www.statonellc.com/eclinical-solutions/) - Stat One is committed to helping companies achieve FDA approval. Through regulatory navigation and expert statistical support, Stat One is laser focused in their services. - [Stat One Team](https://www.statonellc.com/about/stat-one-team/) - The Stat One Team and management includes experienced CRO professionals that are dedicated to providing quality work and service in the clinical trial industry. - [About](https://www.statonellc.com/about/) - Your Trusted Contract Research Organization (CRO) Partner with 30 Years of Excellence in Clinical Trials and eClinical Solutions. - [Services](https://www.statonellc.com/services/) - Stat One is committed to helping companies achieve FDA approval. Through regulatory navigation and expert statistical support, Stat One is laser focused in their services. - [Open Positions](https://www.statonellc.com/open-positions/) - View our open positions to build a career in clinical trials where you will gain a range of experience in statistics, programming, and project operations! - [Brochures](https://www.statonellc.com/brochures/) - View Stat One's brochures highlighting our broad range of experience throughout a broad range of therapeutic areas and services. - [Contact](https://www.statonellc.com/contact/) - Contact Stat One to optimize your clinical data and improve efficiency in your next clinical trial with expert statistical, and data management services. - [News & Information](https://www.statonellc.com/news-information/) - Read the latest blogs and news from Stat One! - [Stat One News](https://www.statonellc.com/stat-news/) - Read current industry-related news from Stat One, including topics such as clinical trials, data capture solutions, FDA guidance, and biostatistical importance. - [Statistical Consulting](https://www.statonellc.com/services/statistical-consulting/) - Statistical consulting services in support of pharmaceutical, biotechnology, and medical device submissions in all areas of the FDA. - [Resources](https://www.statonellc.com/resources/) - View Stat One resources related to the clinical research and therapeutic area expertise in the medical device, pharmaceutical, and biotech industries. - [Careers](https://www.statonellc.com/careers/) - Find careers in the clinical trial industry! Stat One is a specialized contract research organization (CRO) supporting clinical trials and clinical programs. - [Case Studies](https://www.statonellc.com/about/case-studies/) - View real case studies highlighting clinical trial industry trends, the right statistical expertise, customizable EDC, and statistical analysis success stories. - [Client Testimonials](https://www.statonellc.com/about/client-testimonials-2/) - View Stat One client testimonials and why their services lead to success in developing and marketing medical device, pharmaceutical, and biotech products. - [Terms and Conditions](https://www.statonellc.com/terms-and-conditions/) - [Privacy Policy](https://www.statonellc.com/privacy-policy/) - [Programming Services](https://www.statonellc.com/services/programming-services/) - Our team offers SAS and R programming services in support of FDA and EMA submissions. 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