Statistical programming in clinical trials is a vital component of all drug development. Whether you are a Large Pharma, Mid-size Pharma, Biotechnology, Device or Nutraceutical company, you will need to turn your validated data into interpretable information ready for biostatistical analysis.
Statistical Programming enables clinical trial reporting via the creation of regulatory submission ready analysis datasets and production of Tables, Listings and Figures (TLFs). These deliverables help you understand the safety and efficacy of your investigational product and the outcomes of your trial hypotheses.
Quanticate will rapidly resource any studies that you require additional support or expertise on so you can meet your regulatory approval milestones with submission ready deliverables.
Our statistical programmers will seamlessly integrate into your existing team or can form a whole new department depending on your resourcing requirements. Our programmers also work side by side our biostatistics department who have over 25 years of experience which enables us to provide you with additional statistical advise across your studies.
Our statistical programming department is the largest department within Quanticate with over 100 programmers across the globe and a high proportion of senior presence in all regions.
High Quality and On-Time
Quanticate strives towards 100% quality and 100% on time metrics as part of our Coded to Care Philosophy.
Flexibility
We offer the ability to scale up or down to your desired amount of resource in accordance with your pipeline.
Global Reach
With programmers across several continents we are well positioned to support customers and studies around the globe.
24 Hour Access
You will have 24 hour access to our team and constant responses to any requirements you have.
Our expert programmers have detailed knowledge of all Phases and experience of a multitude of therapeutic areas across the drug development spectrum making them an ideal fit within existing project teams at client sites or to form the basis of new teams, forming long lasting partnerships.
SAS and R Programming
Macro production, validation and optimization
Interim Analysis Support
Annual Clinical Trial Safety Updates
CDISC mapping/conversion capabilities
CDISC ADaM submission-ready Dataset Development and QC for Submission Compliance
Data Monitoring Committee (DMC) Data Safety Monitoring Boards (DSMB), Safety Committee and Endpoint Committee Support and mapping of safety data for meetings
Analysis Datasets and TLFs Development, and QC for standard studies and Integrated Summaries
Ensure your trial reporting is accurate and timely with the latest automations and innovative programming techniques in clinical trials.
By Using the Python, R programming and various SAS studio platforms, you will receive accurate and timely deliverables.
Our statistical programmers can:
- Semi-automated SDTM mappingPaula provides overall management and leads client portfolios, ensuring that projects are delivered on time, to budget, to the required quality standards and follow standard operating procedures and processes, as well as ensuring that the applicable regulatory requirements are adhered to.