WHO WE ARE
Atlas-Biostat is a global provider of biometrics services mainly based in Gothenburg, Sweden. Our services involve, but are not limited to, statistical consulting and programming for Biomedical Research and Clinical Trials for both academia and industry.
With high academic qualifications in Mathematical Statistics and long experience from the Pharmaceutical industry working in practically all aspects of pre-clinical and clinical research, we possess both theoretical knowledge and hands on experience in design, analysis and reporting of biomedical studies.
HOW WE CAN HELP
We provide a range of services to our clients including statistical advice, analysis and training.
You can consult us in all statistical matters related to planning, analysis and reporting of biomedical studies. This includes both preclinical- and clinical studies, observational as well as randomized clinical trials (RCT). You can also consult us regarding typical data science tasks and exploratory analyses and data mining based on classical statistical methods or artificial intelligence (AI) type of analyses.
We offer flexible courses at all levels in statistics for statisticians as well as non-statisticians. We can also provide workshops, courses and ad hoc consultancy in statistics or statistical programming for both academia and industry.
An example of such monitoring is drug safety monitoring whereas we can provide support with e.g. review of safety data both within and across studies. Moreover, we can support planned or unplanned interim analyses and corresponding tasks such as data monitoring committee charters, pharmacovigilance and annual safety reports.
We provide a range of services including statistical advice, analysis and training.
Plan your study
Monitor your study
Analyse your data
Interpret your data
Report your results
Publish your results
At Atlas-BioStat we have indepth knowledge of modern statistical methods for medical applications. We support both clinical development trials and research projects from academia or authorities.Our expert biostatisticians combine theoretical knowledge with therapeutic area knowledge and years of experience to support you along the entire clinical development process with study design, study conduct, data collection, analysis and reporting
We can provide highly qualified statistical programming support using current modern CDISC standards for data collection and submission. This includes compliance with Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) structure for compilation of safety and efficacy data, tables, listings and figures (TLFs) for regulatory submissions tailored to the needs of your organization.
Statistical support for clinical trials
Although we have broad expertise in statistical methods as applied to biomedical research in general, our strength is in the area of drug development throughout all preclinical- and clinical phases.
On a trial level, this includes study design, use of modern statistical techniques, sample size calculation, selection of endpoints and analysis methodology. Examples of such techniques are adaptive dose finding, adaptive sample size re-estimation, Bayesian modelling, seamless phase II/III, group sequential approach, modelling and simulation, patient enrichment designs and adaptive randomization. We can also write the statistical section of the clinical study protocol of the trial.
On a clinical program level, we can partner discussions of development plans and interactions with regulatory authorities.
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Selective glucocorticoid receptor modulator AZD9567 has potent anti-inflammatory effect on biomarkers and reduced dysglycemic effects compared with prednisolone in healthy volunteers: two phase 1, single-blind, randomised controlled trials.
Lancet Rheumatology 2020-2