Our Statistical Experience

At Croissance Africa, we possess extensive expertise in biostatistical consulting and services, covering every stage from study design and protocol development to study analysis and regulatory requirements. Our statistical experience spans pre-clinical, clinical, registration phase, and post-marketing studies.

Biostatistics Services Offered

  • Study Design: Crafting robust study designs tailored to your specific research objectives.
  • Protocol Development: Assisting in the development of comprehensive study protocols.
  • Strategic Statical Consulting: Providing strategic guidance and consulting throughout the research process
  • Sample Size Collection: Determining appropriate sample sizes to ensure statistical power
  • End Point Randomization Schemes: Defining clear and relevant study endpoints.
  • Designing effective randomization procedures.
  • Statistical Analysis Plans( SAP): Developing detailed plans for statistical analysis.
  • Adaptative Design Clinical Trial Planning: Planning, simulating, and implementing adaptive design trials.
  • Statistical Tables, Listing and Figures: Creating clear and informative statistical outputs for clinical study reports.
  • eCRF Desing and Review: Designing and reviewing electronic case report forms.
  • Pharmacokinetic: Analyzing drug kinetics and dynamics.
  • Designing effective randomization procedures.
  • Regulatry Submissions: Providing guidance, planning, and representation for regulatory meetings.
  • Interagated Saftey and Efficancy Analysis: Providing guidance, planning, and representation for regulatory meetings Conducting integrated analyses for regulatory submissions.
  • Data Monitoring Committee ( DMC) Services:Supporting DMC activities and reporting.
  • STDM and ADAM Dataset Preparation: Preparing submission-ready datasets in compliance with CDISC standards.

Statistical Programming

Our Statistical Programming team collaborates closely with our Biostatistics team to execute planned analyses and ensure accurate results. Services include:

  • Analysis Dataset Development and Quality Control
  • Creation and QC of Analysis Datasets and Tables, Listings, and Figures (TLFs)
  • CDISC and ADaM Submission-ready Dataset Development
  • Interim Analysis Support
  • Annual Clinical Trial Safety Updates
  • Data Monitoring Committee (DMC) Support
  • Ad hoc analyses for publication summaries and review meetings
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Analyzing
data

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CRF protocal
optimisation

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Generating tables
listings graphs reports

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Simplifying clinical
trial data

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