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Best Practices in Clinical Data Management for High-Quality Outcomes
What is Clinical Data Management and Why Does It Matter? Clinical data management is the systematic collection, cleaning, and analysis of trial data to ensure its quality and integrity. It is a critical process where errors in data are corrected, inconsistencies flagged, and datasets prepared for statistical analysis—all while meeting regulatory requirements and Good Clinical…
Read MoreThe Role of Biostatistics in Drug Development and Clinical Trials
The Role of Biostatistics in Drug Development and Clinical Trials Biostatistics is the driving force behind modern drug development, helping pharmaceutical companies make informed, data-driven decisions. From study design to regulatory compliance, biostatistics plays a crucial role in reducing uncertainty, improving efficiency, and bringing life-changing therapeutics to market. Why Biostatistics is Essential Biostatistics applies statistical…
Read MoreIntroducing Vita Global Sciences
Company expands its clinical research services and delivery models to meet the needs of the global market Vita Data Sciences, a leading provider of clinical data solutions, announced today that it has rebranded as Vita Global Sciences to reflect its growth and diversification in the clinical research industry. The company, which was founded in 2014,…
Read MoreSDTM METHODOLOGY
For SDTM mapping, Protocol and CRF will serve as the initial supporting document. Database schema along with sample data if available will aid in better understanding of the database structure which will give clarity in mapping and defining specification. Annotated CRF (aCRF) will be created against the blank CRF which will map the fields in…
Read MoreTO FSP OR NOT TO FSP….THAT IS THE QUESTION!
Apologies to William Shakespeare. In my 20 years in the Pharma / Bio industry, and in life in general, I have found that often times, its not what you say, its how you say it that matters most. Outsourcing is no different, and with it comes with its own language of relative terms. Ultimately, you…
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