A case report form (CRF, or case study report form) is a paper or electronic questionnaire specifically used in clinical trial research to facilitate data analysis and test hypotheses. The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events. Case report forms contain data obtained during the patient's participation in the clinical trial. Though paper CRFs are still used largely, CRFs (eCRFs) is gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management, and faster database lock, etc.Why Translate CRFs?
More than half of the largest pharmaceutical companies conduct their clinical trials abroad, especially their phase III clinical trials. The International Conference on Harmonisation Guidelines for Good Clinical Practice defines the CRF as a printed, optical, or electronic document designed to record all of the protocol – required information to be reported to the sponsor on each trial subject. CRF may result in many versions, and hence needs to be version controlled. A good translation is now becoming indispensable for conducting successful clinical trials internationally.Features of Our Services
Highly-qualified life science translators and editors.
Adapt complex translation and quality assurance workflows
Meet the most demanding regulatory, quality and budget requirements.
Undergo triple-check quality assurance processes and project-specific protocols.
MedTrans has mastered the right mix of skill and cultural sensitivity to craft culturally adapted translations of CRF.
Identify the key elements (identifiable patient and reporter, suspect drug, and adverse event).
Best fit process to deliver time & quality expectations.
Understand the criticality & client requirements (established in the whole process).
Support materials (templates/glossaries) for the project.
Utilize customized processes and approved teams.
Deliver to the agreed-upon timeline.
Allocate trained resources.
To discuss your specific translation requirements, or to receive more information about our suite of clinical trial translation services, please contact us.
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