Capture, clean and lock your clinical trial data so it’s ready for statistical analysis.
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 use multiple industry-leading electronic data capture (EDC) technologies suited to your requirements and adapted to a decentralized/virtual trial approach.
We offer an end-to-end Clinical Data Management solution including, rapid database launch; integrated clinical data sources; expert medical coding, query management and resolution, effective external vendor data management, database lock; and clean, quality clinical trial data.
We provide bespoke solutions and provide real time, quicker access to data, meaning faster decisions can be made and patients are safe at all times.
Data-focused CROs provide attention and expertise in all areas, especially on data collection and management processes and strategy, we focus purely on data, ensuring a quality service is guaranteed and long-term partnerships are formed.
Our Clinical Data Management team are proficient in the use of R. Allowing the CDM team to integrate the clinical data with increased scrutiny to ensure the quality of the data is as high as possible, while not relying on solely on electronic checks from the EDC system and lengthy SAS listings.
To ensure submission readiness we perform target validation in line with regulatory requirements. Our team work hand in hand with our biostatistics department to identifying the key data domains/variables and create bespoke statistical data checks in line with SDTM/CDISC standards.
This allows for early identification of any erroneous data, therefore minimizing any potential errors post database lock, which in turn helps facilitate high quality statistical outputs which assist the development of clinical study reports and submission packages.
Whatever your trial size, budget or preference, we are experienced across multiple EDC systems. With several partnerships in place with key industry leading EDC vendors, we offer you flexibility and the latest EDC technological advances to met your varying data requirements. These EDC systems offer integrated solutions beyond traditional EDC which allow real-time access to data from different sources.
Our data management experts review the clinical trial protocols to identify the best suiting data collection framework for your study and portfolio.
With over year 20 years in designing EDC studies, we utilize our vendor selected EDC systems to tailor and manage the study needs depending on the trial type. This enables us to support the creation and management for adaptive or First in Human (FIH) trials within the EDC infrastructure with supporting modules such as RTMS and eCOA.
Due to the nature of adaptive trials with their rapid timelines we have experience in supporting clients with the creation of their clinical databases while adhering to strict timelines force upon the client.
We use the latest technologies such as eSource and eCOA to collect data directly from patients and sites, improving patient’s experiences when participating in clinical trials and reducing sites efforts in managing data.
Standard libraries of case report forms (eCRF) enable us to reduce data build time and cost. When data is captured via EDC technologies it is already placed into CDASH standards for efficient mapping to SDTM. Quanticate are experienced in the use of CDISC and CDASH Library formats, additionally we have utilized numerous sponsor/therapeutic specific libraries enroute to successful submissions. The use of these standardized libraries have allowed Quanticate to gain valuable efficiencies with our in-house statistical teams in facilitating quicker analysis outputs to our clients.
As Data Managers we know that Data Quality is vital to trials. Using industry leading RBQM technologies such as CluePoints™ our data managers are able to easily detect outliers, anomalies and potential fraudulent data. By improving your data integrity, you increase the chance of a successful regulatory approval. Our team will develop listings to pull out the data oversight that we wish to achieve on the study which enables us to finds outliers and trends that are of concern. These reports are handed on to your Clinical Project Managers and Clinical Medics where you can make the decision on the type of monitoring strategy best suits your needs.
Quanticate have leveraged the capabilities of Microsoft Power BI to provide clear and concise visualization reports to our customers to help facilitate study governance and oversight.
These customizable reports are designed to allow the client to demonstrate clear GCP oversight while allowing for ease of study monitoring and management.
These visualizations will also allow Quanticate to stay on top if regulatory requirements such as the review of audit trails as it enables Quanticate to extract and analyze the key review points in the report.
We can provide our clients visualizations of their clinical trial data as and when it’s captured before validation within their chosen EDC system.
These visualization 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:
Clinical Data Management (CDM) covers the process of collecting, validating, and preparing the data towards statistical analysis for clinical trials. This starts with setting up a clinical data collection tool(s) or a clinical database based on study protocol to collect and store data. Once data is stored, implementing data validation steps is crucial to ensure accurate data is collected and complies with ICH-GCP and all applicable global and local regulatory requirements. Once the data collected is fit for analysis, the database is locked to avoid any modification and datasets are delivered to statistics and programming teams for analysis.
Learn how to select the EDC solution that best fits your data
Receive support in choosing your clinical trial technology for success
Discover the challenges of gene therapy treatments for rare diseases studies
Explore the results of creating quality clinical trial databases and SDTM templates
Address - UK HQ:
Address - US HQ:
© 2024 Quanticate