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SMART on FHIR and EHR-to-EDC Integration

Kim Rejndrup: Feb 9, 2018 11:00:00 AM

Not long ago, clinical trials involved 100% onsite monitoring in an effort to ensure high data quality. But how effective and efficient was that process? Several analyses have shown that only 1-2% of data is corrected as a result of source data verification (SDV). Therefore, the concept of risk-based monitoring (RBM) was born. The goal was to complete a more targeted monitoring (<100% SDV) without compromising patient safety or data quality.

What Factors Delay Research Studies? Site Survey Delivers Answers

Dennis Constantinou: Jan 18, 2017 8:00:00 AM

Under a crush of data and protocols, very few trials are completed on schedule. In fact, only 6% of clinical trials are completed on time, with the overwhelming majority (72%) running over schedule by at least a month, according to the Center for Information & Study on Clinical Research Participation. Trial designs, increased patient enrollment and extended treatment periods also contribute to time delays, according to researchers in the life sciences industry.

Researchers Face Greater Challenges, Independent Study Says

Dennis Constantinou: Jan 4, 2017 8:00:00 AM

Site researchers report dramatic spikes in the number of procedures and the complexity of tasks related to clinical protocols over the last 10 years, according to an independent study.  Why? Clinical protocols that guide the research team’s activities have increased in complexity, generating more data than ever before.