Digital Data Flow projects
Optimizing efficiency...
Optimizing efficiency in clinical studies is becoming more and more important as study requirements are becoming more complex and means are becoming limiting for development of new drugs that are already in the pipeline.
The main asset in clinical studies is the data. Therefore, improving the digital data flow from study design and data source to regulatory submission is key to the optimization process. This includes data transformation, selection, traceability, lineage and governance.
We are experienced in all aspects of the digital data flow. We are involved in TransCelerates Digital Data Flow project and experienced in implementing the corresponding Unified Study Definition Model (USDM). Furthermore, we provide extensive data selection and mapping services from and to multiple standards. This includes real-world data utilization and mapping.
We are happy to share our ideas and thoughts with you. Contact us through the details you can find on our contact page or send us an e-mail at info@clinline.eu.
Addressing all aspects of the picture
There is no one size fits all strategy to improve efficiency in a specific process. Therefore, a unique and optimal data flow needs to be determined for a specific company and its objectives, by taking their goals, size, current situation, and stakeholder requirements into account. We are here to find that architecture together with you and to optimize your digital data flow by choosing, defining, and implementing the right tools, people and procedures.
TransCelerate Digital Data Flow
We are proud to be involved in the TransCelerate Digital Data Flow project. First as a representative of one of our customers and nowadays on the CDISC side in the development of the corresponding standards. TransCelerate’s Digital Data Flow Initiative seeks to enable the flow of digital study protocol data in order to improve study design and accelerate start-up through automation of processes and setup of study execution systems.
Learn more about this innovative project via the TransCelerate website.
USDM alignment and implementation
The Unified Study Definition Model (USDM) is the new standard that has been developed in the TransCelerate Digital Data Flow project. This new CDISC data model aligns with the new ICH M11 protocol standard and can be utilized to fully digitize the study design. This enables reuse of study design elements and thus increasing consistency between studies and reuse of those elements in downstream processes. Automated feasibility testing, cost assessments, EDC set-up and vendor alignment can all be based on this digitized, standardized information.
If you can use help in assessing how this can work for your organization and how this aligns with your current processes and data storages then you are more then welcome to contact us. We can also assist in the actual implementation of USDM features.
Mastering the Jungle of Real-World Data
Real-World Data (RWD) is increasingly used in regulatory submissions within the healthcare and pharmaceutical industries. The large variety in disparate data sources makes it complex to efficiently leverage the data, assess relevance, and show reliability and traceability. This poster shows how we enable data lineage from real-world data source to submission ready datasets.
In-company workshop
Digital data flow optimization in clinical research
The in-company workshop ‘Digital Data FLow Optimization in Clinical Research’ is a deep dive into your company’s digital data flow and accompanying processes.
This dedicated workshop is adapted to the specific needs of your company. The workshop gives you a basis for further steps to an effective and efficient end-to-end digital data flow including tangible artifacts like a data flow diagram and a stakeholder matrix.
Read more about this workshop in: our digital flyer