Our Services.  ​

QUBES. will support you in every step during  clinical drug development at the asset, indication, or protocol level. 

We can integrate your team as fulltime or part time statistician or offer consultancy in Biostatistics and Data Sciences. Working with a statistician from QUBES., you will be working with a scientist with strong experience in industry, experts in clinical data for drug-development who can lean on the expertise of an entire team.  


Consultancy in Biostatistics and Data Science. Asset/Indication Biostatistician. Protocol Biostatistician.

Consultancy in Biostatistics and Data Science.

We provide support for

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

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Asset/Indication Biostatistician.

  • Understanding the competitive landscape

  • Helping prepare a Clinical Development Plan
  • Scientific and strategic input 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

During study conduct:

  • 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

After database lock, analysis & reporting:

  • Prepare topline meeting and proper 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

  • Support in regulatory authorities face-to-face interactions

  • Support in statistical aspects of HTA dossier preparation

Publications

  • Support to primary and secondary publications