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.
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.
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.
Choose the right Electronic Data Capture system to suit your trial needs and budget
With several partnerships in place with key industry leading EDC vendors, we offer you flexibility and the latest EDC technological advances to meet 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.
Our EDC partners
EDC Systems for Novel Designs and Adaptive Studies
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.
Driving the future of CDM
Risked Based Quality Management (RBQM)
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.
Automated SDTM Dataset Production
By streamlining the production of SDTM datasets we can ensure your trials data will be collected, handled and validated efficiently, and with improved quality. At Quanticate we are pleased to offer all our clients the following SDTM automations that follow a three step process:
- creation of the annotated CRF from the collected data by auto assigning SDTM variables names to CDASH names and arranged appropriately in the CRF template.
- Taking data from the Annotated CRF and automating the production of the specifications for the SDTM datasets
- Taking the specifications and feeding them into our SDTM code generator which writes the majority of the SAS code required to generate the SDTM datasets
This whole process greatly reduces the time to generate our SDTM datasets and at the same time improves their quality.
Patient Centricity with eSource / eCOA
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.
Standardisation and Expansion of Libraries
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 utilised numerous sponsor/therapeutic specific libraries enroute to successful submissions. The use of these standardised libraries have allowed Quanticate to gain valuable efficiencies with our in-house statistical teams in facilitating quicker analysis outputs to our clients.
Visualisations
Governance and Oversight Visualisation
Quanticate have leveraged the capabilities of Microsoft Power BI to provide clear and concise visualisation reports to our customers to help facilitate study governance and oversight. These customisable reports are designed to allow the client to demonstrate clear GCP oversight while allowing for ease of study monitoring and management. These visualisations 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 analyse the key review points in the report.
Clinical Data Visualisations
We can provide our clients visualisations of their clinical trial data as and when it’s captured before validation within their chosen EDC system.
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:
- Oversight of the study in line with GCP requirements
- Up to date metrics to facilitate decision making throughout the lifecycle of the study
- Assist with Risk Management processes
- Provide key insights to the study progress to aide resourcing
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