Partner with the leading niche Clinical Data Management CRO
By choosing Quanticate to manage your Clinical Data Management, you can be confident your clinical trial will be delivered on time with the highest quality data collected.
We utilise our industry-leading unified platform technology partners and their electronic data capture (EDC) systems suited to your requirements and adapted to a decentralised/virtual trial approach.
Data-focused CROs provide attention and expertise in all areas, especially on data collection, management processes and strategy. We focus purely on data, ensuring a quality service is guaranteed and long-term partnerships are formed.
Electronic Data Capture (EDC) Systems Tailored to Your Trial Needs
Selecting the right EDC system is crucial to meeting your trial's unique requirements, timelines, and budget. With several partnerships in place with key industry leading EDC vendors, we offer integrated solutions beyond traditional EDC that provide real-time access to data from multiple sources, flexibility, and the latest EDC technological advances to meet your varying data requirements. Our data management experts analyse your clinical trial protocols to recommend the most suitable framework, ensuring streamlined data collection and compliance with the current ICH E6(R2 guidelines, as well as the upcoming ICH E6(R3) revision. This ensures your trial benefits from a risk-balanced approach that prioritises efficiency, data quality, and patient safety.
Our Trusted EDC partners
We collaborate with industry-leading EDC technology vendors to offer solutions that are designed to meet the diverse needs of clinical trials. These include advanced visualisations and insights, user-friendly platforms for streamlined trial management, integrated workbench tools for centralised monitoring, and scalable systems built for reliability and flexibility.
EDC Systems for Novel Designs and Adaptive Studies
Our 20+ years of experience in EDC design enable us to create tailored solutions for adaptive trials, First-in-Human (FIH) studies, and other novel trial designs. We leverage advanced EDC features to accommodate rapid database creation and tight timelines while incorporating modules like real-time monitoring systems (RTMS) and eCOA to enhance trial flexibility and usability. These systems are optimised for the demands of modern trials, ensuring smooth execution and timely results.
Governance and Oversight Visualisations
Our Microsoft Power BI-powered reports offer clear, concise insights designed for study governance and oversight. These customisable reports support compliance with Good Clinical Practice (GCP) by enabling clients to monitor study progress, manage resources, and demonstrate oversight with ease. These visualisations also allow us to stay on top of regulatory requirements, such as audit trail reviews, by enabling us to extract and analyse key data points in the report to ensure adherence to ICH guidelines.
Clinical Data Visualisations
We provide real-time visualisations of your clinical trial data as and when it’s captured within your chosen EDC system, even before validation. These visualisation reports allow you to review the progress of your study in advance of key milestones throughout the study up to database close, allowing your project teams to take a step back from the data and view the trial as a whole. This brings multiple benefits of:
- Maintain oversight of the study in line with GCP requirements
- Access up-to-date metrics for informed decision-making at every stage.
- Support Risk Management processes, including monitoring Key Performance Indicators (KPIs) and transitioning from Quality Tolerance Limits (QTLs) to Acceptable Ranges per ICH E6(R3).
- Gain key insights to optimise resourcing and monitor study milestones ahead of database close.
Decentralised and Virtual Trials with Patient-Centric Solutions
At Quanticate, patient-centricity is at the core of our approach to modern trials, ensuring a seamless experience for participants and robust outcomes for sponsors. We are dedicated to advancing patient centricity in clinical trials through innovative decentralised and virtual trial designs. By utilising the latest technologies, such as eSource and eCOA, we enhance the patient experience while streamlining data collection and reducing the burden on site staff.
eSource and eCOA for Improved Patient Experience
Our eSource and eCOA platforms enable direct data capture from patients and sites, simplifying trial participation and improving patient engagement. These tools not only enhance the patient experience but also reduce site workload, ensuring trials run efficiently without compromising data quality.
Centralised EDC Systems for Virtual Trials
In decentralised and hybrid trial designs, our EDC central systems act as the backbone, seamlessly integrating data from eSource, eCOA, wearable devices, and real-world data sources. This centralised approach provides real-time access, enhances study oversight, and supports informed, timely decision-making.
Advancing Patient-Centric and Remote Solutions
By embracing patient-centricity, our modern trial solutions minimise logistical challenges for patients, increase retention, and uphold data integrity. This approach is designed to align with the evolving needs of advanced trial designs, offering flexibility and reliability while ensuring compliance with industry standards.
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