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.

📊 How do you conduct a successful observational study?Observational studies are essential for generating real-world evid...
26/02/2026

📊 How do you conduct a successful observational study?

Observational studies are essential for generating real-world evidence, which is why getting the design right is critical.

This blog covers:
🔹 Defining clear research objectives
🔹 Selecting the appropriate study design
🔹 Managing data effectively and minimising bias
🔹 Ensuring robust and reliable outcomes

📖 Read the full guide: https://hubs.li/Q043-DFD0

🤝 Considering an FSP model for your clinical development program?Functional Service Provider (FSP) models offer flexibil...
24/02/2026

🤝 Considering an FSP model for your clinical development program?

Functional Service Provider (FSP) models offer flexibility and scalability, but successful implementation requires careful planning.

This blog explores what it takes to implement an FSP model effectively, from defining scope and governance to ensuring alignment across sponsors and CRO partners.

🔗 Read the full article: https://hubs.li/Q043-j3H0

🎧 QCast Episode 33: eCRF Design in Clinical TrialsListen as Jullia and Tom break down eCRF design in clinical trials and...
23/02/2026

🎧 QCast Episode 33: eCRF Design in Clinical Trials

Listen as Jullia and Tom break down eCRF design in clinical trials and its impact on data quality, site workload, and downstream analysis.

👆 Find it here, or search QCast on your favourite podcast provider: https://hubs.li/Q043YHWV0

20/02/2026

📢 NEW PODCAST EPISODE: Therapeutic Areas in Clinical Research

In this episode, Jullia and Tom explore therapeutic areas in clinical research, why they matter beyond a clinical label, and how they shape trial design and delivery.

👂 Click here to listen now: https://hubs.li/Q043YFJv0

19/02/2026

📢 NEW BLOG: What is the FDA's Technical Rejection Criteria for Study Data?

Understand the FDA's Technical Rejection Criteria for study data submissions, common failure points in eCTD structure, and practical steps to reduce risk.

📖 Read it here: https://hubs.li/Q043QLnP0

When you're ready to begin the database lock (DBL) process, it means you're nearing the end of your data management proc...
18/02/2026

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 acheiving a robust DBL,such as:
🔹 Why database lock matters 🗂️
🔹 Key steps for a seamless process ✅
🔹 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. 💪
https://hubs.li/Q043CnZ90

🏅 Set Your Clinical Trial up for Success with a well written SAPA Statistical Analysis Plan (SAP) is essential for ensur...
13/02/2026

🏅 Set Your Clinical Trial up for Success with a well written SAP

A Statistical Analysis Plan (SAP) is essential for ensuring clarity and consistency in clinical trials, helping to reduce variability or odd results. A well-structured SAP defines analysis methods, avoids ambiguity, and streamlines regulatory submissions.

Our blog covers:

🔹What goes into a strong SAP
🔹Best practices for creating a SAP
🔹Steps to ensure a submission-ready SAP

Don't get stuck with a bad SAP. Read our blog below. 👇
https://hubs.li/Q042_KyX0

12/02/2026

📢 NEW BLOG: Regulatory Submissions in Clinical Trials

What are regulatory submissions in clinical trials? Our blog explores key submission types, practical steps to build and validate the package, and common pitfalls when it comes to submitting.

📃 Read the full blog here: https://www.quanticate.com/blog/regulatory-submissions-in-clinical-trials



10/02/2026

📢 NEW PODCAST EPISODE: Risk-Based Quality Management in CDM

In the latest episode of QCast, Jullia and Tom unpack risk-based quality management and why it's central to protecting participant safety and reliable trial results.

👂 Listen here, or on your favourite podcast provider: https://hubs.li/Q042vf_z0

🧬 Understanding Expansion Cohorts in Phase I Oncology TrialsPhase I isn’t just about dose-finding anymore. In oncology, ...
06/02/2026

🧬 Understanding Expansion Cohorts in Phase I Oncology Trials

Phase I isn’t just about dose-finding anymore. In oncology, expansion cohorts allow researchers to explore early signs of efficacy and safety in specific patient subgroups, helping to bridge the gap between initial safety and future trial phases.

This blog unpacks how expansion phases are used, their strategic benefits, and what sponsors should consider when planning early-phase oncology trials.

🤔 Give it a read here. https://hubs.li/Q041XQVj0

🎙️ QCast Episode 30: Adaptive Randomisation in Clinical TrialsIn this episode, Jullia and Tom explore adaptive randomisa...
05/02/2026

🎙️ QCast Episode 30: Adaptive Randomisation in Clinical Trials

In this episode, Jullia and Tom explore adaptive randomisation in clinical trials as an attractive alternative to fixed allocation when evidence is accumulating.

🎧 Available to listen now: https://hubs.li/Q041-Fgj0

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