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Automated data reconciliation of the clinical and safety databases - Thesis Example

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It is accredited that clinical data are critical corporate assets in the biopharmaceutical industry of today, and that converting data into meaningful information is vital for core sponsor firms to make assessments faster and in a more flexible manner.
Adoption of clinical…
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Automated data reconciliation of the clinical and safety databases
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Download file to see previous pages It saves time, and more importantly, gets rid of possible discrepancies between databases. Whenever discrepancies are possible, it necessitates extra quality assurance steps for resolving mismatches (Zhengwu Lu, & Lu, Zhengwu, 2009).
Serious Adverse Event, SAE, and Adverse Event, AE, reconciliation compares specific data between two databases; a clinical database and a safety database. A clinical database defined as s closed system while a safety database as an open system. A clinical database can review data for only a short time period that is lasting of the trial, hence defined as closed. A safety database on the other hand, is an open system due to its continuous reception of new SAEs or updates of SAEs that already exist concerning any clinical trials even when they are locked (Van et al 2012).
Data management performs the task of SAE and AE reconciliation. Two departments are normally involved, the pharmacovigilance and drug safety, and clinical data science. During the data reconciliation, SAE is collected in the safety database and in the clinical database. Data cleaning takes place according to the specifications of data validation (Dwivedi & IGI Global, 2009).
SAE reconciliation is performed continually between first patient first visit, FPFV, and last patient last visit, LPLV. The reason for such timely performances provides data that is reliable and trustworthy, that is of greatly useful in decision-making processes on a drug’s safety profile and successive trial design. It also ensures consistency in reporting to health authorities regarding individual Safety reports, New Drug Application, and the annual Investigational New Drug Update (Trasi, 1994).
The skill set accessible in the data management section, many additional things can be done. The interior talents of the section are not fully utilized. It is not fulfilling for persons and the organization. The prospects and the demands are there. ...Download file to see next pagesRead More
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