Statistical Programming Services

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.

Statistical Programming CRO

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 philosophy.

Flexibility

Quanticate strives towards 100% quality and 100% on time metrics as part of our Coded to Care Philosophy.

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

Why Quanticate?

Customer Care

Industry leading customer care and Coded to Care philosophy embedded in our company culture
Many positive customer testimonials and long-term, growing partnerships
Award winning Partner of Choice and Trusted by Top Pharma
Flexible to client processes and ability to adapt to client systems and SOPs

Experience

One of the world’s largest data focused CROs with experience supporting many types of studies
Highly experienced leadership and governance team who provide advice as to the most efficient way of running your trial putting the patient safety ahead of financial gain
Senior business leaders within the company involved in portfolio delivery and project management of your studies
Several partnerships in place with industry leading technology vendors and equipped to support both virtual and decentralized trials

Quality

Industry renowned Quality-focused global graduate program
Highly regulated so excellent internal procedures, SOPs and framework
Data is our priority as everything we do and not an afterthought to higher revenue generating services like clinical trial monitoring
Quick and easy access to expert statistical consultancy and able to apply additional value without unnecessary bureaucracy or complex communication channels
Regularly cited in reputable scientific publications alongside industry partners

Innovations & Automation

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 mapping
- Automatically generate TLFs using our standard macro packages
- Semi-automatic submission ready packages (Define XML, Reviewers Guide & Analysis Metadata)

Submit an RFI

Team Leaders

Karen Ooms

Executive Vice President, Head of Statistics

Karen Ooms is responsible for overseeing the Statistics department at Quanticate. Karen is a Chartered Fellow of the Royal Statistical Society and has a background in biostatistics spanning over 25 years. Prior to joining Quanticate in 1999 (Statwood), Karen was a Senior Statistician at Unilever.