Quanticate

Quanticate Welcome to Quanticate's page. We are a leading global Clinical Research Organization (CRO).

Quanticate, with headquarters in the UK and USA, is a specialist Clinical Research Organization (CRO) primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing surveillance. We provide very efficient outsourcing solutions for companies who need additional capacity or who want to outsource certain functions in their entirety. We deliver scalable on-site and off-site data management, statistical consultancy, statistical programming & analysis, medical writing and pharmacovigilance services. We also have a staff recruitment arm, "Quanticate People", to help Sponsors find all types of permanent and contract staff. Quanticate works closely with biotech, pharmaceutical and medical device companies and prides itself in being a seamless extension of its customers’ internal teams. Many of our customers choose Quanticate simply because they want to know that their data will be looked after by a specialist biometrics CRO. We offer that specific expertise and the attention necessary to properly manage, analyze and report valuable data. With a combination of on-shore and off-shore resources spanning four continents, Quanticate is renowned for its customer service, scalability and superior results.

07/11/2025

πŸ“’ NEW PODCAST EPISODE: Missing Data in Clinical Trials

In this QCast episode, co-hosts Jullia and Tom explain why missing data threatens unbiased estimation, how the estimand framework shapes prevention and analysis, and what clear reporting looks like from first patient in to database lock.

πŸ†• Availble to listen now: https://hubs.li/Q03S8Cvp0

🫰 The True Cost of Poor DataMissing values. Inconsistencies. Errors. Even small issues can cause headaches and pain poin...
06/11/2025

🫰 The True Cost of Poor Data

Missing values. Inconsistencies. Errors. Even small issues can cause headaches and pain points in clinical trials. Delays and increased costs can be avoided by ensuring data accuracy and consistency from the beginning.

All that's left to ask: how can teams improve clinical data quality from the start? πŸ€”

Our blog answers your questions about quality data:
πŸ”Ή Common data quality pitfalls and how to prevent them πŸ›‘
πŸ”Ή Best practices for improving accuracy and consistency βœ…
πŸ”Ή How automation and technology can minimise human error πŸ’»

Read more here: https://hubs.ly/Q03R-dxB0

When you're ready to begin the database lock (DBL) process, it means you're nearing the end of your data management proc...
30/10/2025

When you're ready to begin the database lock (DBL) process, it means you're nearing the end of your data management process. What you include in your DBL is what will be presented to the FDA, which is why it's imperative to get it right. Any delays or errors at this stage can lead to regulatory setbacks and increased costs.

Our blog details different aspects of achieving a robust DBL, such as:
πŸ”Ή Why database lock matters πŸ—‚οΈ
πŸ”Ή Key steps for a seamless process βœ…
πŸ”Ή Common pitfalls and how to avoid them ⚠️

A well-executed DBL keeps trials on track and ensures high-quality data submissions.

Ensure high-quality data submissions with a strong DBL. πŸ’ͺ
https://hubs.li/Q03QZD2D0

ICYMI: Everything You Need to Know About Project Optimus πŸ”¬The maximum tolerated dose (MTD) approach has long been the st...
28/10/2025

ICYMI: Everything You Need to Know About Project Optimus πŸ”¬

The maximum tolerated dose (MTD) approach has long been the standard in oncology trials, but is it the best method? Project Optimus is shifting the focus towards dosing strategies that maximize efficacy while reducing toxicity. βš•οΈ

Biotech and pharma teams need to understand how this initiative impacts trial design through new dosing strategies. Discover more here: πŸ‘‡
https://hubs.li/Q03QmRHC0

πŸ“š Using Historical Data to Inform Future Decisions in Clinical TrialsWell-curated historical data can be a robust resour...
23/10/2025

πŸ“š Using Historical Data to Inform Future Decisions in Clinical Trials

Well-curated historical data can be a robust resource in planning your future clinical trial.

In this blog, we explore how leveraging existing trial data can support:
πŸ”Ή More efficient study designs
πŸ”Ή Improved risk assessment
πŸ”Ή Informed dose selection and comparator choice

Whether you're designing a first-in-human study or preparing for regulatory submission, incorporating historical insights can enhance decision-making across your development program.

πŸ”Ž Find the full blog here: https://hubs.li/Q03LTtcX0

πŸ’­ Contract Research Organisation or Clinical Research Organisation?While the acronyms are often used interchangeably, th...
21/10/2025

πŸ’­ Contract Research Organisation or Clinical Research Organisation?

While the acronyms are often used interchangeably, there’s value in understanding the nuance behind each.

This blog unpacks the definitions, roles, and services commonly associated with both terms, clarifying how these organisations support sponsors throughout the clinical development lifecycle.

Whether you're selecting a CRO for the first time or re-evaluating your outsourcing strategy, it’s worth revisiting what these terms mean in today’s industry context.

πŸ”Ž Find the full aerticle here: https://hubs.li/Q03P7tx_0

20/10/2025

πŸ“’ NEW PODCAST EPISODE: Dose Expansion in Oncology Trials

Join Jullia and Tom as they explore the dose expansion phase of Phase I oncology trials and break down the bridge between dose finding and proof of concept.

🎧 Listen to it now: https://hubs.li/Q03P7pnW0

17/10/2025

πŸ“’ NEW BLOG: What Does a Clinical Trial Manager Do?

From protocol development to site oversight, CTMs play a pivotal role in keeping trials on track, on budget, and compliant.

In this blog, we break down:
πŸ”Ή The key responsibilities of a CTM
πŸ”Ή How they collaborate across teams
πŸ”Ή Why their role is essential for trial success

πŸ“– Read more: https://hubs.li/Q03P7-w10

16/10/2025

πŸŽ™οΈ QCast Episode 16: Statistical Analysis Plans (SAPs)

Take a closer look at SAPs with the QCast hosts, Tom and Jullia. Learn how a good SAP can bolster submissions and strengthen data analysis across your team.

πŸ‘‰ Listen here, then take a look at our back catalogue of episodes: https://hubs.li/Q03NTB5f0

πŸ“Š Clinical Data Management: Laying the Groundwork for Reliable TrialsAccurate, compliant, and well-structured data is es...
13/10/2025

πŸ“Š Clinical Data Management: Laying the Groundwork for Reliable Trials

Accurate, compliant, and well-structured data is essential for regulatory success. And it starts with robust clinical data management (CDM) practices.

This blog outlines key CDM considerations that help ensure quality across every phase of a clinical trial. Whether you're refining current processes or planning for an upcoming study, these best practices are worth revisiting.

πŸ“— Read it here: https://hubs.li/Q03LTwf00

08/10/2025

🎧 QCast Episode 15: CRF Annotation in Clinical Trials

Unpack CRF annotation with the QCast hosts. Jullia and Tom cover practical workflows, cross-functional sign-off, and version control through amendments.ο»Ώο»Ώ

πŸ‘‹ο»Ώ Find it here, and listen to other QCast episodes: ο»Ώhttps://www.quanticate.com/podcast/episode-15ο»Ώ

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πŸ“ˆ Real-World Data Analysis in Clinical Trials: Opportunities & ConsiderationsReal-world data (RWD) is becoming an increa...
07/10/2025

πŸ“ˆ Real-World Data Analysis in Clinical Trials: Opportunities & Considerations

Real-world data (RWD) is becoming an increasingly powerful asset in clinical research, complementing traditional trial data and enhancing the relevance of findings.

This blog explores how RWD can:
πŸ”Ή Support trial design and endpoint selection
πŸ”Ή Improve generalisability of results
πŸ”Ή Strengthen regulatory and payer submissions

Learn how to navigate the challenges and unlock the full value of real-world data in your development programs.

πŸ‘† Check it out here: https://hubs.li/Q03MghvC0

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