{"id":4151,"date":"2025-07-22T14:44:58","date_gmt":"2025-07-22T12:44:58","guid":{"rendered":"https:\/\/mediconomics.com\/biostatistics-in-clinical-research\/"},"modified":"2025-07-23T16:40:20","modified_gmt":"2025-07-23T14:40:20","slug":"biostatistics","status":"publish","type":"page","link":"https:\/\/mediconomics.com\/en\/biostatistics\/","title":{"rendered":"Biostatistics in clinical research"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"4151\" class=\"elementor elementor-4151 elementor-4134\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-235ad45 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"235ad45\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-9d2b137\" data-id=\"9d2b137\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-32cbcac elementor-widget elementor-widget-image\" data-id=\"32cbcac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"99\" height=\"99\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/03\/Icon_CRO_RGB_blau_2025.png\" class=\"attachment-full size-full wp-image-2026\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-df381a1\" data-id=\"df381a1\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6834490 elementor-widget elementor-widget-heading\" data-id=\"6834490\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Biostatistics in clinical research<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-478f2df elementor-widget elementor-widget-button\" data-id=\"478f2df\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#contact\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cdc931d wellen subsite elementor-widget elementor-widget-html\" data-id=\"cdc931d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"uuid-4b071659-7ca4-4560-8197-62f6aba045f6\" data-name=\"Ebene 2\" viewbox=\"0 0 841.89 570.97\">\n  <defs>\n    <style>\n .uuid-6bf3c995-831e-45fa-a548-05e06c0bcdf1 {\n fill: none;\n stroke: url(#uuid-8d285012-e631-4f90-ab8a-74a7ed5687ac);\n stroke-miterlimit: 10;\n stroke-width: .32px;\n }\n    <\/style>\n    <lineargradient id=\"uuid-8d285012-e631-4f90-ab8a-74a7ed5687ac\" 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 <\/g>\n<\/svg>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3fc2be5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3fc2be5\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ea5389a no-box-shadow-mobile\" data-id=\"ea5389a\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-00a3b1a elementor-widget elementor-widget-heading\" data-id=\"00a3b1a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Our services in biostatistics:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-623547d elementor-widget elementor-widget-text-editor\" data-id=\"623547d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\">\n<li>Statistical study planning<\/li>\n<li>Creation of statistical analysis plans<\/li>\n<li>Statistical programming &amp; analysis<\/li>\n<li>Creation of tables, listings and figures (TLFs)<\/li>\n<li>Statistical review &amp; method development<\/li>\n<li>Subgroup, sensitivity and interim analyses<\/li>\n<li>Planning, implementation and evaluation of interim analyses<\/li>\n<li>Interim Data Reviews<\/li>\n<li>Quality assurance &amp; testing for regulatory compliance<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a8a1661 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a8a1661\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-eb49e70 no-box-shadow-mobile\" data-id=\"eb49e70\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-f26ca56 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f26ca56\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-4849be8\" data-id=\"4849be8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7c2e25b elementor-widget elementor-widget-heading\" data-id=\"7c2e25b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Our range of services includes:<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-118f4ea elementor-widget elementor-widget-text-editor\" data-id=\"118f4ea\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>We offer a comprehensive range of services in the field of biostatistics that is specially tailored to the requirements of your clinical studies. Our aim is to support you from study planning to final analysis with scientifically valid and regulatory compliant statistical solutions. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-6edff40 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6edff40\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-789a30a\" data-id=\"789a30a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ed60dbf elementor-widget elementor-widget-heading\" data-id=\"ed60dbf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Study planning &amp; design<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4a814f5 elementor-widget elementor-widget-text-editor\" data-id=\"4a814f5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In the early phase of your study project, we work with you to develop a customized statistical study design that is optimally tailored to your research question<span style=\"font-size: 17px;\">.<\/span><span style=\"font-size: 17px;\">This includes<\/span><\/p><p><span style=\"font-size: 17px;\"> <\/span><\/p><ul class=\"dashed\"><li>Selection of a statistically suitable study design<\/li><li>Well-founded sample size and power calculations Careful definition of primary and secondary endpoints<\/li><li>Creation of detailed statistical analysis plans (SAP)<\/li><li>Conduct of transparent and comprehensible data analyses<\/li><li>Compliance with regulatory requirements<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-46ecbff elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"46ecbff\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-098f1d6\" data-id=\"098f1d6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e43a25b elementor-widget elementor-widget-heading\" data-id=\"e43a25b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Statistical programming &amp; analysis<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d183220 elementor-widget elementor-widget-text-editor\" data-id=\"d183220\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Using modern statistical software tools such as SAS and R, we carry out the statistical analyses of your clinical trials &#8211; promptly, reliably, transparently and in compliance with regulatory requirements.<\/p><p>Our services range from exploratory data analyses and interim analyses for decision support to final efficacy and safety evaluations after study completion.<\/p><p>We develop, validate and implement complex statistical programs for the creation of:<\/p><p> <\/p><ul class=\"dashed\"><li>Tables, listings and figures (TLFs) for study reports, submissions or publications<\/li><li>ADaM data sets (Analysis Data Models) as the basis for verifiable analyses<\/li><li>SDTM data sets (Study Data Tabulation Models) for structured archiving and regulatory submission<\/li><\/ul><p> <\/p><p>It goes without saying that we follow international standards, in particular <strong>CDISC <\/strong>(Clinical Data Interchange Standards Consortium), as well as regulatory requirements from the EMA, FDA and other authorities. Our evaluations are comprehensible and fully documented &#8211; including tested program codes and validation reports relating to raw data, analysis data sets and results. <\/p><p>The aim of our statistical programming is to deliver reliable, comprehensible and regulatory recognised results &#8211; as a basis for your well-founded decisions in the further development process of your medicinal products or medical devices<span style=\"font-size: 17px;\">.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-ec8aef4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ec8aef4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-ceeb798\" data-id=\"ceeb798\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-078b104 elementor-widget elementor-widget-heading\" data-id=\"078b104\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Statistical review &amp; method development<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9a5b48a elementor-widget elementor-widget-text-editor\" data-id=\"9a5b48a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>An expert statistical review forms the basis for reliable results and regulatory-compliant study progression. Our experienced biostatisticians check your existing study documents &#8211; such as study protocols, statistical analysis plans (SAPs) and case report forms (CRFs) &#8211; for statistical plausibility, consistency, completeness and regulatory compliance. The aim is to identify potential methodological weaknesses at an early stage and ensure the scientific quality of your study by making suitable adjustments.  <\/p><p>In addition, we develop innovative statistical analysis approaches to provide targeted answers to complex or specific questions. <span style=\"font-size: 17px;\">These include, among others:<\/span><\/p><p><span style=\"font-size: 17px;\"> <\/span><\/p><ul class=\"dashed\"><li>Subgroup analyses to evaluate relevant patient groups in a differentiated manner and make clinically significant effects visible<\/li><li>Interim analyses, with clearly defined decision criteria for possible study adjustments, e.g. for safety aspects or efficacy trends<\/li><li>Sensitivity analyses to check the robustness of the results under different models<\/li><\/ul><p> <\/p><p>A particular focus is on advising on and implementing adaptive study designs that allow flexible adjustment to interim results &#8211; e.g. changing the number of cases, adjusting dosages or modifying endpoints. We accompany you through all phases, from methodological planning and communication with the regulatory authorities to implementation in the analysis phase. <span style=\"font-size: 17px;\">Our methodological expertise also includes<\/span><\/p><p><span style=\"font-size: 17px;\"> <\/span><\/p><ul class=\"dashed\"><li>Multiple test corrections and adjustments for multiple comparisons<\/li><li>Time series analyses, survival time analyses and mixed models<\/li><li>Handling missing data (e.g. imputation techniques according to ICH E9)<\/li><li>Development of validatable models for risk or efficacy assessment<\/li><\/ul><p>With this broad spectrum, we ensure that your study not only complies with regulatory requirements, but also delivers methodologically sound, convincing results &#8211; as a solid basis for approval, market positioning or publication.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-4e9b86b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4e9b86b\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-99e7d17\" data-id=\"99e7d17\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5888ff1 elementor-widget elementor-widget-heading\" data-id=\"5888ff1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Interim analyses &amp; blind data reviews<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d9c1e23 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d9c1e23\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Interim analyses and blind data reviews are key tools for quality assurance and data-based management of clinical trials. They make it possible to evaluate the course of the study on the basis of preliminary data &#8211; without jeopardizing the blinding or compromising the integrity of the final analysis. <\/p><p>We take over the planning, implementation and evaluation of interim analyses for you, which can have the following objectives, among others:<\/p><p> <\/p><ul class=\"dashed\"><li>Early assessment of efficacy or safety parameters<\/li><li>Decision on continuation, modification or early termination of the study<\/li><li>Adjustment of study parameters, e.g. number of cases, randomization ratio or dose groups<\/li><li>Review of recruitment process, data quality and protocol compliance<\/li><\/ul><p> <\/p><p>We also carry out structured Blind Data Reviews (BDR) &#8211; an essential step in quality assurance before database lock. <span style=\"font-size: 17px;\">Thereby:<\/span><\/p><p><span style=\"font-size: 17px;\"> <\/span><\/p><ul class=\"dashed\"><li>All available data systematically reviewed without unblinding<\/li><li>Data gaps, inconsistencies and anomalies identified and documented<\/li><li>Queries triggered in a targeted manner and tracked together with data management<\/li><li>Critical variables (e.g. primary endpoints) particularly carefully validated<\/li><li>Plausibility checks and protocol conformity ensured<\/li><\/ul><p> <\/p><p>We create comprehensive interim reports with clear recommendations and a basis for decision-making that can be used both for internal project decisions and for bodies such as data monitoring committees or authorities. We ensure that all assumptions, analysis steps and results are presented transparently &#8211; always in accordance with the previously defined analysis plan. <\/p><p>With our interim analyses and blind data reviews, we create certainty before important study decisions are made &#8211; neutral, compliant and scientifically sound.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-5c5c1d5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5c5c1d5\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-ec66fb3\" data-id=\"ec66fb3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6c8969b elementor-widget elementor-widget-heading\" data-id=\"6c8969b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Quality assurance &amp; compliance<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a8e96c5 elementor-widget elementor-widget-text-editor\" data-id=\"a8e96c5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Our statistical services comply with strict regulatory requirements such as GCP (Good Clinical Practice), the ICH guidelines (in particular E3 &#8211; &#8220;Structure and Content of Clinical Study Reports&#8221; and E9 &#8211; &#8220;Statistical Principles for Clinical Trials&#8221;) as well as the requirements of the FDA according to 21 CFR Part 11 for electronic records and electronic signatures. <span style=\"font-style: inherit; font-weight: inherit;\">We provide you with comprehensive support for the:<\/span><\/p>\n<p><span style=\"font-style: inherit; font-weight: inherit;\">&nbsp;<\/span><\/p>\n<ul class=\"dashed\">\n<li>Interpretation and practical implementation of regulatory requirements in study design, analysis planning and reporting<\/li>\n<li>Preparation and review of study protocols, SAPs and CSRs with a focus on regulatory compliance<\/li>\n<li>Preparation and submission of regulatory documents, e.g. for EMA, FDA, BfArM or PEI<\/li>\n<li>Preparation of Health Technology Assessment (HTA) dossiers, including the compilation of statistical evidence for cost-benefit assessments<\/li>\n<li>Participation and advice in Data Monitoring Committees (DMCs), including preparation of interim statistical evaluations, security analyses and decision papers<\/li>\n<\/ul>\n<p>Our experienced statisticians work closely with colleagues from Regulatory Affairs, Medical Writing and our Clinical Data Management to ensure an integrated, consistently traceable data and analysis chain.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6d38b777 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6d38b777\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-48169096 no-box-shadow-mobile\" data-id=\"48169096\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-49149377 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"49149377\" data-element_type=\"section\" data-e-type=\"section\" id=\"contact\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-6468f4f7\" data-id=\"6468f4f7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2bc8090 elementor-widget 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value=\"27\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages\/4151\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-27\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Send\" aria-live=\"assertive\" value=\"wpforms-submit\">Send<\/button><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/mediconomics.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container --><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-50245fc columns-mobile-and-tablet elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"50245fc\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-b76962d\" data-id=\"b76962d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d8b5e67 image-br elementor-widget elementor-widget-image\" data-id=\"d8b5e67\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"833\" height=\"1024\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-833x1024.jpg\" class=\"attachment-large size-large wp-image-1982\" alt=\"Uwe_Albrecht\" srcset=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-833x1024.jpg 833w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-244x300.jpg 244w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-768x944.jpg 768w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-1250x1536.jpg 1250w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025.jpg 1512w\" sizes=\"(max-width: 833px) 100vw, 833px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-219b2e9 elementor-widget elementor-widget-text-editor\" data-id=\"219b2e9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Dr. (MD) Uwe Albrecht,<br>FIBMS, FFPM (Dis.), FICR, CSci<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20fc7bb elementor-widget elementor-widget-text-editor\" data-id=\"20fc7bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>CEO<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-f490ede\" data-id=\"f490ede\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-991e429 image-br elementor-widget elementor-widget-image\" data-id=\"991e429\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"605\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-1024x605.jpg\" class=\"attachment-large size-large wp-image-1983\" alt=\"Hauptsitz_Mediconomics\" srcset=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-1024x605.jpg 1024w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-300x177.jpg 300w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-768x454.jpg 768w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-1536x907.jpg 1536w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025.jpg 1920w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d758337 elementor-widget elementor-widget-text-editor\" data-id=\"d758337\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Headquarters<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2541fad elementor-widget elementor-widget-text-editor\" data-id=\"2541fad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Hanover<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-bc5f915 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"bc5f915\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e8e7f7d\" data-id=\"e8e7f7d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3ed630d elementor-widget elementor-widget-heading\" data-id=\"3ed630d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><b>FAQ<\/b> \u2013 frequently asked questions<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ad92ceb elementor-widget elementor-widget-html\" data-id=\"ad92ceb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"custom-dropdown\">\n    <div class=\"dropdown-header\">\n  What are the advantages of integrating Mediconomics biostatistics into my study project at an early stage?\n    <\/div>\n    <div class=\"dropdown-content\">\n As early as the concept phase, the biostatisticians carry out sample size estimations and power calculations, select the optimal study design and create a detailed Statistical Analysis Plan (SAP) so that primary and secondary endpoints are precisely defined and regulatory requirements are met from the outset. This reduces subsequent protocol amendments, increases statistical power and accelerates the overall development timeline. \n    <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0bd21a9 elementor-widget elementor-widget-html\" data-id=\"0bd21a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"custom-dropdown\">\n    <div class=\"dropdown-header\">\n  How does Mediconomics support adaptive study designs and interim analyses?\n    <\/div>\n    <div class=\"dropdown-content\">\n  Mediconomics plans and evaluates adaptive designs (e.g. Group-Sequential, Sample-Size-Re-Estimation, Bayesian Adaptive Trials) already in SAP, carries out simulation-based type I error checks and prepares interim reports for Data Monitoring Committees. This allows study progressions to be flexibly adapted and resources to be used efficiently. \n    <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-261a85f elementor-widget elementor-widget-html\" data-id=\"261a85f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"custom-dropdown\">\n    <div class=\"dropdown-header\">\n  Does Mediconomics offer support in the development of biometric endpoints?\n    <\/div>\n    <div class=\"dropdown-content\">\n  Yes. Our biostatisticians develop suitable endpoint definitions, carry out correlation analyses on clinical outcomes and evaluate statistical models to validate new surrogate markers. \n\n    <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ed880ec elementor-widget elementor-widget-html\" data-id=\"ed880ec\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"custom-dropdown\">\n    <div class=\"dropdown-header\">\n  What is the cost structure for biostatistics projects?\n    <\/div>\n    <div class=\"dropdown-content\">\n Mediconomics offers flexible pricing models, e.g. flat rates for SAP creation, hourly rates for programming and quality control as well as project-based fixed prices for project packages. Transparently listed budget items enable clear cost control. \n    <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Biostatistics in clinical research Contact us Our services in biostatistics: Statistical study planning Creation of statistical analysis plans Statistical programming &amp; analysis Creation of tables, listings and figures (TLFs) Statistical review &amp; method development Subgroup, sensitivity and interim analyses Planning, implementation and evaluation of interim analyses Interim Data Reviews Quality assurance &amp; testing for regulatory [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-4151","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages\/4151","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/comments?post=4151"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages\/4151\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=4151"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}