J Data Analytics & Consulting*
QUALIFIED LIFE SCIENCE CONSULTANTS AND SUPPORT RE.
DATA ANALYSIS, COMPUTERIZED SYSTEMS AND DEVELOPMENT OF DIAGNOSTICS AND MEDICINES
*in affiliation with
Jacobsson Analtics & Consulting AB
ClinStorage AB
QUALIFIED CONSULTANCY AND SUPPORT- THE LIFE SCIENCE TOOLBOX
STATISTICAL ANALYSIS, DATA ANALYTICS AND MACHINE LEARNING
- Uni- and Multi-variate analysis/Bayesian statistics
- Classification and regression by for example OLS, PCA, XGBoost and CATboost, Neural Networks
- Stability study data (ICH Q1)
- Process control charts
- Assay development and validation (ICH Q2) statistical aspects
- Design and evaluation
- Diagnostic tools and evaluation
- 1D and imaging analysis
- Clinical study design
- Power calculations
STATISTICAL ANALYSIS OF DRUG STABILITY DATA, E.G. AN EXAMPLE ON APPROVED VS REJECTED ACCORDING TO ICH
COMPUTERIZED SYSTEMS
- Implementation and validation of computerized systems (e.g E-lab book, LIMS, Sample management systems)
- We can help you to streamline your operations and develop smart solutions
- Automation of laboratory processes maximizes throughput and minimizes sources of error
- Implement EMS systems including temperature mapping
- Compliance IT projects, such as data integrity, ER&ES and validation. QA role in Computer / IT system validation
DEVELOPMENT OF NEW DIAGNOSTICS AND MEDICINES - CHEMISTRY, MANUFACTURE, CONTROL
- Cell and gene therapy
- Biologics (antibodies, fusion proteins, recombinant proteins and biosimilars). (ICH Q5, 6B)
- Small molecules / nano-particles
- Risk management tools and support in development and production
- Implement systems, procedures and guidelines for that business (PQS ICH Q10)
CRITICALITY OF CORRECT TEMPERATURE MAPPING
- The original qualification of the climate cabinet was not correct performed
- Deviation rised during an audit
- MPA not approved the qualification due to incorrect temp mapping
- Position of the temp sensor and the setup of the temp-mapping is critical to capturing all variations in the cabinet
