Digital Data Flow projects

Optimizing efficiency in clinical trials...

With the introduction of new ICT methods, the usage of real-world data, and the increasing pressure on the drug market, it is possible and high time to change the old-fashioned, time-consuming and costly step by step approach which is still followed by many companies in our industry. Adaptive study designs, real-world control arms and automatic source data collection are, for example, much more effective when standard ‘old-aged’ business-structures are redesigned. We advice a step by step approach for improvement in our industry processes to keep track of results, ensure stakeholder cooperation and a higher chance of success. 

There is no one size fits all strategy to improve efficiency in a specific process. Therefore, a unique and optimal architecture needs to be determined for each company, by taking its goals, size, current situation, and stakeholder requirements into account. We are here to find that architecture together with you and to optimize your processes by choosing, defining, and implementing the right tools, people and procedures. 

Our extensive knowledge of industry solutions, stakeholder management, and planning are key to our success and 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.

See below some of the activities we have provided regarding the digital data flow.

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

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 their 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.