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Estimondo GmbH

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Über uns

Estimondo GmbH 

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Estimondo is a consultancy agency focused on offering expert services in statistics and statistical programming. We are looking back on up to more than 28 years of experience in clinical research with widespread expertise in therapeutic arears and clinical phases. We are providing resources and expert knowledge seamlessly and fully according your needs. All our services are client-oriented, paperless and based on lean quality processes. Estimondo puts the latest technology to use. Team members are qualified and intensively trained and all relevant guidance documents are applied. Our focus is on advanced statistical design and analysis tailored to your needs. Meta-data driven, our neural expert writing system and our statistical programming environment for clinical studies ensure on-time high-quality deliverables. As an independent statistics and programming service provider, our passion is the world of estimands. Please contact us for more information or request a proposal. We are happy to support you with one of the best benefit-cost ratios in class. Visit our website under www.estimondo.com.

Our services include statistical writing, statistical programming, statistical analysis, statistical science, sourcing and related other services.

Statistical Writing                 Clinical trial protocols and protocol amendments, observational plans, statistical analysis plans including tables, figures and listings shells, ICH E3 clinical trial reports, non-interventional and epidemiological study reports, summaries of clinical efficacy and clinical safety, AMNOG benefit dossiers, abstracts, manuscripts and posters

Statistical Programming     Development programming and independent QC/validation programming; preparation of programming plans and comprehensive documentation of deliverables, derivation of analysis data sets and production of in-text and post-text tables, figures and listings; data mapping of legacy data to CDISC SDTM, ADaM, CRT-DDS (define.xml 2.0, SDRG, ADRG); set-up and maintenance of clinical data marts and clinical data warehouses; data file conversions; data inspection tests; data reviews and data visualization

Statistical Analysis               Interim, final and post-hoc analyses; planning, conduct and reporting of meta-analyses; efficacy, safety, quality of life, pharmacokinetics, pharmacodynamics, and health economics; data mining and predictive analytics, biomarker identification and safety signal detection; statistical data monitoring (ongoing throughout project lifetime, support to drug safety reviews, central clinical monitoring, independent statistical analysis center)

Statistical Science                Design of experiments; sample size determination and adaptation; modelling & simulation; method evaluation and implementation

Sourcing                                  Provision of experienced onsite or remote resources in biostatistics and statistical programming

Other services                       Lectures in statistics for healthcare professionals; macro programming and validation; medical writing and data management via partners

Steckbrief

Branche

  • Beratung, Consulting