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.

20/11/2025

πŸ“’ NEW PODCAST EPISODE: The Role of Reconciliation in Clinical Data Management

Listen as Jullia and Tom unpack data reconciliation in clinical data management. Understand what reconciliation is and why it underpins data integrity and safety oversight.

πŸ‘‚ Find it at this link, or on your favourite podcast provider: https://hubs.li/Q03TYBPx0

🌟 Optimising Early Phase Clinical Trials with BOIN Design 🌟Discover the statistical benefits and practical applicability...
19/11/2025

🌟 Optimising Early Phase Clinical Trials with BOIN Design 🌟

Discover the statistical benefits and practical applicability of Bayesian Optimal Interval (BOIN) designs. This method adapts dose levels based on patient responses, ensuring the optimal balance between safety and efficacy. Compared to the traditional 3+3 design, BOIN offers enhanced precision, flexibility, and patient safety.

Interested in learning more about how BOIN can transform your clinical trials? Check out our blog here πŸ‘‰ https://hubs.li/Q03TLqBx0

πŸŽ™οΈ QCast Episode 18: Real World Evidence in Clinical TrialsQCast hosts Jullia and Tom unpack the impact and important us...
18/11/2025

πŸŽ™οΈ QCast Episode 18: Real World Evidence in Clinical Trials

QCast hosts Jullia and Tom unpack the impact and important use cases of real-world evidence and data in modern drug development.

πŸ‘‚ Search 'QCast' on your favourite streaming platform, or click here to listen: https://hubs.li/Q03Sz0K90

🎧 QCast Episode 19: Data Validation in Clinical Data ManagementIn this episode, Jullia and Tom demystify data validation...
12/11/2025

🎧 QCast Episode 19: Data Validation in Clinical Data Management

In this episode, Jullia and Tom demystify data validation in clinical data management, discussing how risk-based approach safeguards data integrity and supports lock.

πŸ‘† Click here to listen: https://hubs.li/Q03SyLXD0

πŸ“Š ISS & ISE Analysis in SAS: What You Need to KnowIntegrated Summary of Safety (ISS) and Integrated Summary of Efficacy ...
11/11/2025

πŸ“Š ISS & ISE Analysis in SAS: What You Need to Know

Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) analyses are a vital aspect of regulatory submissions. They help to provide a full picture of your clinical trial data and can simplify the management of large datasets when used effectively.

Our blog explores:
πŸ”Ή Best practices for ISS/ISE analysis in SAS βš™οΈ
πŸ”Ή Common challenges and how to navigate them πŸ”„
πŸ”Ή Regulatory considerations for submission-ready datasets πŸ“‘

Adopt better data analysis with ISS and ISE. πŸ“ˆ
https://hubs.li/Q03SyB1X0

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

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