Case Study

Accurately Aligning Data Structures That Can Stand Up To Regulatory Scrutiny

Source: Cmed Clinical Research Services
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Cmed's Data & Analytics team demonstrated their commitment to provide flexible and innovative solutions to meet the requirements of complex clinical trial situations

Situation

A biopharmaceutical company had an ongoing observational study with 120 patients in 5 sites. As the team started to plan their first Phase I study they realised that they wanted to align the data structures from both studies.

The observational study had been initiated in another EDC system but this was not a suitable solution for the sponsor. The preference was to adopt encapsia (Cmed's proprietary EDC and analytics platform) to take advantage of its advanced analytical capablity.

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Cmed Clinical Research Services