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Name

Bio-statistical Support

Organization name

Soladis

Profile

SOLADIS is a consulting company dedicated to statistics, biostatistics and valorisation of data.

Founded in 2000 by an experimented team previously working in an international pharmaceutical and chemical group (Rhône-Poulenc), SOLADIS provides its services through audit/validation, consulting, training sessions, and statistical programming and analysis in order to support your studies and projects.

Thanks to our 25 employees, with various backgrounds, we apply our expertise in various areas in the field of Life Science and created a strong synergy with our experience in various projects.

The Life Science Sector (Pharma, MD, Biotech, Cosmetics) represents today 75% of our activities. SOLADIS supports industrial, R&D and marketing projects in Europe, mainly related to preclinical and clinical studies.

The role of Soladis is to quantify and qualify the problematic through a rigorous scientific methodology based on:

  • observation: definition of experimental and measure design, methodology to qualify data…
  • analysis: optimal exploitation of available data, validation of mathematical models…

More specifically, regarding preclinical & clinical studies, we support our partners via:

  • Elaboration & validation of the statistical parts of the protocols (methodology, number of patients, number of centers, primary & secondary endpoints…),
  • Blank CRF & e-CRF validation and management,
  • Database creation,
  • Drafting & validation of the SAP,
  • SAS programming,
  • Statistical analysis,
  • Intermediary analysis,
  • Statistical reports redaction to be handed to the FDA, EMA or any authority,
  • Support in the FDA/ EMA submission & examination.

Since the field of Life Science represents today 75% of our activities, we are used to apply the regulatory and quality requirements to our work. We mainly work with the reference software SAS, and our collaborators are certified to the following training programs:

  • SAS Base programming,
  • SAS Modelling,
  • SAS BI,
  • SAS Clinical Trial (collaborators trained, waiting for a certification date).

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