Real World Data

Optimizing clinical trial performance with Real World Data

Optimal usage of real world data for your trial reduces time to market and increases the knowledge of the actual patients and markets in an early trial stage. Using it for selection of study participants, finding the right location of your patients, using it as input of the study database or using it as a control study arm, each solution has its challenges. This includes:

– Automation processes and ETL 
– Statistical design of studies
– Effective and efficient usage of data for trial design and validation
– Effective and efficient usage of EHR data in clinical trials
– Privacy and governance of data

ClinLine facilitates and advices on the usage of real world data for clinical trials. We select and audit data centers providing the data, advice on the statistical and technical design of the study and support in protocol design and review. 

Our workshop “Improving clinical trial efficiency by using Real World Data” will handle different aspects of using real world data. See the corresponding workshop page for more information.


Check of the trial population and eligibility criteria

The real world eligibility tool

The Real World Eligibility Check 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 avoided. It also is used to get an impression of the patient population in certain countries. The tool is independent and interoperable with data standards like CDISC, OMOP and FHIR but can also be filled with data adjusted to a basic defined import format. It will be run at the location of the data centre which solves most privacy issues as individual data will not be shared by the data centre. The tool contains automatic input definition generation and data validation algorithms to ensure that the analysis is correctly done. Analysis is standardized preventing the occurrence of any interpretation differences between data centres in the analysis of the data. A uniform report is generated based on the results of the different global data centres.

 

Like to know more or to get a personal presentation of the tool? We are happy to share our ideas and thoughts with you. See our contact page directly or send an e-mail to info@clinline.eu.