Statistical Programming Services

The vital component of all drug development.

Whether you are a Large Pharma, Mid-size Pharma, Biotechnology, Device or Nutraceutical company, statistical programming in clinical trials is crucial for helping you 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.

High Quality & On-time

Quanticate strives towards 100% quality and 100% on time metrics as part of our philosophy.

Flexibility

Easily scale resources up or down to meet your needs. We integrate seamlessly as an extension of your team.

Global Reach

With programmers on multiple continents and worldwide coverage, we are well-positioned to support global customers and studies.

24-Hour Access

You will have 24-hour access to our team and constant responses to any requirements you have.

SAS and R Programming with Macro Development

We combine extensive data analysis with expert macro production, validation, and optimisation to streamline processes and ensure efficient, reliable outcomes.

Interim Analysis Support

Our team ensures efficient and accurate processing of interim analysis data by preparing and validating datasets, and generating outputs like tables, listings, and figures (TLFs) in compliance with protocol requirements.

Annual Clinical Trial Safety Updates

We prepare and validate safety datasets for annual reports, ensuring accurate data processing, and generate required outputs to support regulatory submissions.

CDISC, SDTM and ADaMs Experts

We specialise in converting raw clinical data to CDISC SDTM formats and developing ADaM compliant datasets, ensuring they are submission-ready and meet regulatory standards.

Safety Data Support for DMC, DSMB, and Endpoint Committees

We offer support for safety data preparation and mapping, ensuring accurate and timely information for Board and Committee meetings. Our service facilitates informed decision-making and smooth committee operations throughout the trial.

Clinical Trial Reporting

We develop and quality check analysis datasets and TLFs for standard studies and integrated summaries (ISS/ISE). Our submission-ready outputs provide clear insights, supporting key study findings and meeting regulatory standards.

Data Anonymisation Specialists

Our team provides programming solutions to anonymise clinical trial data to protect patient privacy, while maintaining data integrity.

Submission Requirements

We provide tailored support for submission deliverables, including the creation of BIMO listings, ISS/ISE and other regulatory-required outputs, ensuring they’re prepared efficiently and accurately.

OUR EXPERTISE

SDTM Automation Specialists

Automated Flow Integration: Our automation starts with the annotated Case Report Form (aCRF), progressing seamlessly through SDTM specs to SDTM code, ensuring each step feeds into the next optimising efficiency and ensuring compliance.
Hands-On SAS Expertise: We leverage SAS extensively, automating 80% of the SDTM code, which allows us to dedicate time to the 20% that is unique to each study, such as treatment regimens and third-party data sources, ensuring tailored and effective solutions.
Balanced Automation and Human Input: While our automation processes save time and money, we emphasise the importance of expert human input to maintain high-quality standards in our SDTM implementation.
Experts in Complex Study Designs: Our statisticians and programmers excel in handling non-standard, complex study designs, where full automation may not be sufficient. We provide flexible, customised solutions for these challenging projects ensuring thorough and accurate results that are still fully compliant to CDISC standards.

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Accelerate Your Drug Development with Specialist Programming Support

Discover how our statistical programming team enabled rapid response in vaccine development, delivering high-quality data solutions in record time. Click below to explore our case study and learn how our expertise can streamline your clinical trials.

Why Partner with Us?

Next-Gen Automation with AI & ML Integration

Using our in-house automation tools alongside industry-leading AI/ML technologies, we streamline programming workflows to enhance speed, accuracy, and consistency, delivering reliable results while freeing your team to focus on the research.

Over 30 Years of Specialised Expertise

As one of the world’s largest global biometric & data CRO’s, we bring deep technical knowledge to data processing, analysis, and regulatory compliance across all phases and therapeutic areas. This expertise ensures high-quality, reliable results tailored to the complex needs of every trial.

Intelligent Governance with Real-Time Project Visualisations

Our governance model, optimised with advanced project management visualisations, provides flexible resourcing that adapts seamlessly to your project’s needs. This data-driven approach ensures precision and alignment with your objectives at every stage.

Integrated Cross-Functional Capabilities

Our seamless collaboration across CDM, statistics, and medical writing teams ensures precise alignment and rapid issue resolution at every stage. By closely coordinating data base lock timings, dataset standards, and document formatting, we improve data quality and expedite critical deliverables, enabling you to achieve faster, high-quality results tailored to regulatory and reporting needs.

Transparent Partnership, Built for You

We pride ourselves on openness and honesty in every engagement, tailoring our services around your unique needs. Our goal is to offer solutions that maximise the value of our expertise for you, ensuring your trial is optimised for efficiency, cost-effectiveness, and meaningful data outcomes.

FSP Expertise for Enhanced Collaboration

As experienced FSP specialists, we work as an extension of your team, providing a collaborative and flexible approach to programming services. Our tailored support in data preparation, analysis, and reporting adapts to your needs, enhancing efficiency and ensuring consistent, high-quality outcomes at every stage.

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Efficient and Compliant Solutions for Seamless Approvals

Our programming team is highly skilled in the regulatory requirements specific to clinical data analysis and reporting. This expertise ensures that every dataset, output, and submission meet regulatory standards, which is especially valuable for small and mid-size companies facing complex compliance requirements.

Access to Expertise at Every Level

Our flat hierarchal company structure provides you with direct access to our entire team, from analysts to our COO's. Founded by statisticians who understand the clinical trial process end-to-end, we ensure agile, informed support at every stage, enhancing efficiency and alignment with your objectives.

Accelerated Data-Driven Deliverables

Leveraging our specialised focus on clinical data, we deliver faster turnaround times for analysis datasets, TLFs, and reporting. Our streamlined workflows and technical expertise reduce project timelines, allowing you to make timely, informed decisions that keep your trial on track.

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