Our Services.  ​

Consultancy in Biostatistics and Data Science.

We offer assistance in:

• Methodology & Research
  
• Due Diligence
  
• Statistical training to non-statisticians

Asset or Indication Biostatistician.

• Analyzing the competitive landscape

• Assisting in the preparation of a Clinical Development Plan
• Scientific and strategic insight for successful regulatory and HTA approvals
• Development of Core and Integrated Statistical Analysis Plans.

Protocol Biostatistician.

Study design:

• Protocol design (sample size through modelling, objectives, endpoints, estimands, analyses)
• eCRF, IVRS review DMC charter authoring, including all statistical aspects related to DMC activities

Study Monitoring:

• Support in DMC meetings reports preparation 
• Study-specific Statistical Analysis Plans (SAP)
• Supervising internal or external statistical programming team to ensure timely & high quality deliverables
• Statistical data review
• Interim analyses statistical related activities
• Database lock statistical related activities

Analysis and Reporting:

• Prepare topline meeting and ensure accurate interpretation of study results

• Support in statistical exploratory analyses as required

• Support for Clinical Study Report authoring 

Regulatory & HTA submissions:

• Support in regulatory submission preparation

• Assistance in direct interactions with regulatory authorities

• Support with statistical components of HTA dossier development

Publications:

• Support to primary and secondary publications