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30-Apr-2019

Perfectly designed eCRF is a key to clinical trials success

Every clinical research organisation has to ensure that all clinical trials data are collected, stored and maintained according to ICH-GCP and GDPR requirements. Using sophisticated passwords, naming conventions, modern technology, hardware and software of the highest standards is obvious. The real key to a clinical trial success is perfectly designed eCRF which can fulfill demands of all parties: Sponsors, CROs and healthcare authorities.

CROPRIME (the UK based clinical research organisation) launches a very modern eCRF design and implementation program. The idea of the program was to create a multi-functional team of individuals who develop a study specific CRF based of a protocol requirement. It is not a very standard process. Usually a Sponsor must put a lot of efforts in developing the system and implementing the protocol into the existing CRF template. CROPRIME works differently. Their specially trained team of data managers, clinical development and operation professionals, scientists and project managers study, the protocol and design a tailor made CRF for a specific study requirement.

CRF is planned once a study protocol is ready however CROPRIME is happy to start the preparation in a parallel with finalizing the protocol. It gives more time for all parties to analyse and develop the system. Attention to details is crucial at this stage. Only clinical trials professionals can ensure nothing is missing.

Every clinical trial is different. There are no two identical studies. High end engineering is a must. CROPRIME makes sure all data are kept correctly in CRF. Scientists review a newly designed CRF, make comments and prepare a final report before CRF is implemented. All efforts allow to create a tailor made CRF with very clear functionally which capture all necessary, study specific information. Well prepared CRF assure data integrity and data quality. All thanks to a dedicated team which design data collection, data review and data storing in a very sensible and intuitive way. CRF is followed by specially prepared guidelines which help data and project managers, sites personnel, CRAs to review and easily analyse the content.

If you want to learn more about it please get in touch with CROPRIME Ltd via email: info@croprime.com. All emails are answered within 24 hours. The typical CRF implementation takes between 1 to 3 months (all depends on the project).

Perfectly designed eCRF is a key to clinical trials success

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Last Updated: 01-May-2019