EstiMates

Bridging Science and Data

Statistical & Data Leads

Whether it is a clinical trial project, submission to a health authority, or any other complicated data project. We steer you through it.

Statistical & DM applications

Study designs, analysis plans, reporting, interpretations and programming. eCRFs, Data management plans, managing clinical data during the study. We have the expertise to guide you to success.

Improved insights

Data science, Machine learning, Real world data and Cloud computing. We apply novel methods to help you to maximize the value of your data.

Bridging Science and data

EstiMates is a newly-founded (2021) Finnish statistical consultancy company. Our founders have particularly strong statistical background in pharmaceutical, nutritional and academic clinical research. Our aim is to bridge science and data and to provide a wide angle to all data related questions.  ​

Solid Project lead and Collaboration

We provide innovative, flexible solutions to any statistical issue and smooth, active collaboration with other members of the project team. ​We offer oversight and management services throughout all biometrics activities.

Our expertise

Our team consists of highly experienced biostatisticians / data scientists.  We have long-term industry-experience in a wide range of therapeutic areas and have substantial expertise in all clinical trial phases and academic research.

Understanding the Standards

We thoroughly understand ICH/ GCP requirements and follow carefully FDA, EMA, EFSA standards and have also direct FDA-submission experience. We continuously train ourselves regarding new/updated guidance’s (e.g. ICH E9 addendum, Points to consider on implications of Coronavirus disease (COVID-19).​ Our Clinical Data Management processes are in compliance with the regulatory standards (e.g. 21 CFR Part 11), utilizing Viedoc as our EDC-partner.

Services

Statistical Lead

Expert leading e.g. drug development company or project in all statistical activities​. Lead activities may also cover the whole biometrics area from data management to statistical programming.

Statistical Planning

Study design support e.g. applying estimands framework, adaptive designs. Regulatory interactions, Study protocols, Statistical analysis plans, Sample size calculation for any research project.

Statistical Reporting

Conduction of statistical analyses, programming of study outputs, reporting and interpreting the results. In addition, post-hoc analyses (plans, conduct), and supporting manuscript preparations.

Statistical Programming

Integration of study databases, CDISC standardization. RBM programming & dashboards to identify risks and comply with regulation. Complicated data engineering.

Data Science

Planning and executing data science workflows to gain insights from your data. E.g. Machine learning models for big data, NLP models for advanced text categorization.

Data Visualizations

Interaction with visualizations leads to discoveries. Diving deeper to the data, when questions arise. Online visualisations with interactivity. e.g. Patient profile visualizations for medical monitoring.

Data Management

Customized electronic data capture, eCRF and database design, integrated eDiaries to any clinical study with documented data management and data validation plans. Managing clinical data during the study in compliance with the regulatory standards (e.g. 21 CFR Part 11). Medical coding (MedDRA, ATC, WHO DD) and data standardization according to CDISC standards (SDTM).

Bioinformatics

Wide-range of bioinformatics services for next-generation sequencing, including e.g. genomics, metagenomics and transcriptomics. Bioinformatics workflows can always be customized for your specific project. We naturally also provide statistical analyses for the final report.

Mates

Teppo Huttunen, CEO

  • 20 years of experience in statistics and in CRO leading roles​
  • Multiple therapeutic field experience (Ophthalmology, Neurology, Oncology)​ Including regulatory interactions.
  • Finnish member in the European federation of pharmaceutical statistician council​

Mika Mäkinen, CFO & Data Science Lead

  • 15 years experience in diagnostics, big pharma, finance, procurement​
  • Experienced Lead in data projects
  • Excels in Programming (R and SAS), Data Science and Business Intelligence.

Jouni Junnila, CSO

  • 15 years experience in CRO, big pharma, 5 years leading experience​
  • Multiple therapeutic field experience (Ophthalmology, Nutrition, Oncology) and preparation of health technology assessment(HTA) dossier.​
  • Co-author of ~50 peer-reviewed scientific publications

Aki Linden, Principal Statistical Programmer

  • 10 years experience in CRO and insurance​
  • Excellence in Statistical programming (SAS and R)​, including RBM activities.
  • Experience of generating submission-packages for FDA.

Tuomas Kuusisto, Principal Statistical Programmer

  • 10 years experience in CROs
  • Excels in data standardization (CDISC), including corresponding documentation activities. Experienced in output-programming, data visualization, simulations.
  • Experience of generating submission-packages for FDA

Olena Olishevska, Statistical Programmer

  • 3 years of experience in CRO
  • Excels in data standardization (CDISC), SEND, SDTM, ADaM and output programming; data visualization.
  • Experience in clinical (Oncology, Cardiovascular, Respiratory, Ophthalmology, Psoriasis) and preclinical (Pain) studies.

Tero Jalkanen, Senior Data Scientist

  • 15 years of experience in big pharma and academia
  • Experience in Womens’ Health, Animal Health, and Oncology
  • Experienced project manager for data and modelling projects. Has implemented models for a broad range of applications.

Juha-Pekka Virtanen, Data Management Lead

  • 10+ years’ experience in CRO and academia
  • Experienced to work in Oncology, nutrition, infectious and mental health
  • An expert in project management, eCRF designing and maintenance.

Contact us Today!

mates@estimates.fi

or firstname.lastname@estimates.fi