Catalyst understands clinical biometrics is more than just numbers

Statistics drives and influences efficient study design that enables the extraction of critical information concealed within data. Our specialist team is committed to offering a flexible and collaborative approach to maximise study accuracy, compliance, and success. Catalyst’s team can provide support in statistical programming, EDC builds, data management and biostatistics offering a holistic approach to your data needs.

Data Management

The results of any study are only as good as the quality and accuracy of the data collected.  This is why Data Management is a critical function on any clinical trial. 

Catalyst offers a full range of Data Management Services for clinical studies from Phase I – IV, both as a single service and alongside other Catalyst functions. Our dedicated team of Data Managers and EDC Developers ensure compliance and completeness. Our team helps you optimize your clinical studies, regulatory submissions, and overall clinical development plans by ensuring that data currency and accuracy is managed on an ongoing real time basis.

Our team support: 

• • eCRF design 
  • EDC development and edit checks 
  • User Acceptance Testing 
  • Data Management Documentation: 
    
    1. Data Management Plan 
    2. Data Quality Review Plans (DQRP) 
    3. Data Reconciliation Trackers
    4. Autoload Processing
    5. Coding Plans
    6. Data Transfer Specification (DTS) in conjunction w/programming
  • Data  Visualization 
  • Data Standards Support

  Catalyst’s team is proficient across a range of EDC tools including, but not exclusive to: Medidata for Rave™, DataTrak, Oracle RDC, Medrio, OpenClinica, Triakit, Viedocs, Zelta enabling us to collaborate with you on a system of your choice.

Biostatistics

Quantifying Certainty

Biostatistics is the heart of a clinical trial. Our biostatisticians have over 15 years of experience in marketed therapeutics with NDA/BLA/PMA submissions and interactions with the FDA/EMEA and PMDA. With expertise spanning Bayesian and Adaptive designs, Catalyst can provide regulatory support and documentation to execute your study.

Regulatory guidance requires a statistician to be involved in the design of any clinical trial. Our statisticians are therefore involved throughout the concept stages of trial, through the study itself, then through the analysis, reporting, interpretation, and regulatory submission.

Our statisticians regularly support with:

• Trial Design – Bayesian and Group Sequential  
• Sample size calculations 
• Protocol Development  
• Statistical Analysis Plan Development  
• PK/PD Modelling  
• Provide input to: Abstracts/Posters/Manuscripts  
• Randomization Services  
• Adaptive Design Analysis 
• DMC, DSMB, and Interim Analyses 
• Statistical consulting 
• TLF review 
• Statistical and Clinical Statistical Reports  
• Statistical modelling and simulation 

Statistical Programming

Optimize your clinical studies with fully customized regulatory submission-ready analysis datasets and tables, listings, and figures through our team of R and SAS programmers. Our programmers are trained in ICH/GCP and CFR PART 11 regulations and equipped with globally accepted tools and resources. 

Our Statistical Programming Team provides services in:

• CDISC, SEND, SDTM & ADaM standards compliant datasets development and quality control
• Tables, Listings, and Figures Generation
• DMC, DSMB, and Interim Analysis support 
• Ad- Hoc Analysis
• Rescue Studies
• PK/PD Programming
• Bioresearch Monitoring Support
• Integrated summaries for regulatory submissions

Our programming team have a breadth of experience across all stages of clinical development, therapeutic areas, and phases of studies plus are well versed with regulatory requirements and associated data packages. .