Real-World Data Utilization in Clinical Research

Real-World Data Utilization and Real-World Evidence generation can and will reduce time and costs in clinical trials. Using real-world data for  pre-study feasibility assessments, real-world data synthetic control arms, and follow-up patient monitoring is more and more becoming practice.

With our knowledge and experience, we provide all-round services in this area including: 
– Study feasibility assessments and tooling (see bottom of this page)
– Data selection
– Data mapping and standardization
– Dataflow architecture
– Data reliability and robustness testing
– In-company workshops and guidance dedicated to real-world data utilization in regulatory clinical trials

Our services range from consultancy, requirement definitions, and on-site (management) support to actually carrying out the whole process and assessments. We work together with renowned partners in the industry and real-world data centers.

In-company workshop Effectively using Real-World Data in your clinical development program

The in-company workshop ‘Effectively using RWD in your clinical development program’ is intended to explore whether real-world data can be effectively leveraged for your specific investigational product. This question cannot be generally answered as it heavily depends on the endpoints, covariates, and global areas that are to be included in the trials.

This dedicated workshop consists of two four-hour sessions and is adapted to the specific needs of your clinical investigation program.


The workshop gives you a basis for further steps to effectively utilize real-world data for your clinical trials while aligning with regulatory requirements. Based on your needs, the following topics will be covered during the workshop:

  • Availabilityvof specific endpoints, selection criteria and covariates in real-world data sources.
  • (New) regulatory requirements and corresponding assessments and reports.
  • Relevance of data sources and how to select and validate them.
  • Data selection and inferences.
  • Propensity matching, windowing and missing data.
  • Data governance and privacy.
  • Data accrual and validation.

If you like to know more about this workshop, contact us for an open and obligation-free meeting with our experienced and knowledgeable consultant Berber Snoeijer at info@clinline.eu.

Check of the trial population and eligibility criteria

The real world eligibility tool
The Real-World Eligibility tool is designed at ClinLine to check the eligibility criteria of a study during the study design phase. By doing this, potential selection problems during the execution of the study can be detected and avoided. The tool is also used to get an impression of the patient population in different global areas. It is independent and interoperable with data standards such as CDISC, OMOP, and FHIR, but can also be filled with data adjusted to a basic defined import format. The tool is run at the data center, solving most privacy and governance issues as individual data is not shared by the data center. The tool contains automatic input definition generation and data validation algorithms to ensure that the analysis is performed correctly. Analysis is standardized, preventing the occurrence of interpretation differences between data centers’ analyses of the data. A uniform report is generated based on the results of the different global data centers.

Would you like to know more or are you interested in a personal presentation of the tool? We are happy to share our ideas and thoughts with you. Go to our contact page or email us at info@clinline.eu.

 

See also these LinkedIn articles on Real World Data usage:

– The future of effective clinical data storage and usage
– Five important real world data aspects for consider for clinical studies
– Privacy in Clinical Research and Real World data: sharing experiences
– Will RWD break down the barriers in data processing
– Real world data in clinical trial