4Pharma - Beyond Your Data

Statistics


Statistics

4Pharma provides high-quality, cost-effective solutions to ensure the successful management and delivery of clinical trial data in accordance with your timelines and budget. We provide you with state-of-art biostatistics services by highly experienced pharma professionals to support you in these processes. The exceptional pharma experience of our staff enables us to act in senior roles within (bio)pharma companies or providing statistics for single studies, clinical or non-clinical. Our statisticians support regulatory interactions and help optimize the design of the clinical program and ensure submission readiness.

Statistical services:

  • Protocol development support
  • Sample size calculation
  • Detailed Statistical Analysis Plans (SAP)
  • Support for Data Monitoring Committees (DMCs) and Data Safety Monitoring Boards (DSMBs)
  • State-of-art statistical analyses
  • Support for regulatory submissions (incl. EMA, FDA)
  • Interim and meta analysis
  • Publication support
  • Statistics for integrated summaries of safety and efficacy
  • Statistical analyses of Real World Evidence data to support market access
  • Tailored training in statistics
  • Insourced resources
  • Data visualization
  • Centralized statistical monitoring
  • Consultation

Programming services:

  • Source data sets (including SDTM)
  • Analysis data sets (including ADaM)
  • Data listings and patient profiles
  • Summary tables and graphs
  • Program validation
  • Development and validation of SAS macros
  • Data pooling and integration
  • Risk-based monitoring data presentations
  • Conversion of clinical databases into CDISC data models

 

Design & Interpretation

4Pharma statisticians can contribute in the design of clinical programs and clinical trials to help optimize endpoint selection, sample size and power calculations. Modeling and simulation are helpful tools to ensure all available information is utilized in the design phase.

Scenario planning for go-no-go decisions as well as further explorative data analyses are often crucial in the interpretation phase, this is where 4Pharma statisticians can help companies understand the data and ensure informed decision making.

Health Technology Assessment (HTA)

HTA is a multidisciplinary process to evaluate the social, economic, organizational and ethical issues of a health intervention or health technology. 4Pharma statisticians can help with data mining and statistical analyses on Real World Evidence data as well as conducting additional explorative analyses on clinical trial data that to support the dossier. Our team has experience from several different markets and can provide valuable insights.

Risk-Based Monitoring (RBM)

Risk-Based Monitoring (RBM) allows targeted monitoring of sites to identify issues and improve site performance. This is achieved by evaluating the risks at each site and then making a decision on when, what sites and what data to monitor. Centralized statistical monitoring is when site data is evaluated for risks in real time from a single off-site location using complex statistical algorithms to discover outliers and data anomalies. This technique can help to detect erroneous data and site misconduct upfront and pro-actively take actions to protect the data quality.

Related services

Want to know more?

Contact our specialist directly, we gladly answer your question.

Jouni Junnila , Head of Statistics