Who we are
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 areas and clinical phases. We are providing resources and expert knowledge seamlessly and fully according to your needs. All our services are client-oriented, paperless and based on lean quality processes. Estimondo puts the latest validated technology to use. Team members are qualified and intensively trained and all relevant guidance documents are applied. 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.
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 and 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
Average years of experience
Clinical research projects experienced
Hours from unblinding to validated TLFs
Statistical methods in use