Analyzing Clinical Trial Management Systems

Clinical Trial Management Systems Though all four systems of Clinical Data Management (CDM) seem to possess identical functionality, it appears that Perceptive Informatics is more useful, as it requires complex IT infrastructure for its functioning. CDM represents a crucial clinical research phase that generates superior, statistically sound, and reliable information from the clinical trial phase. This aids in drastically reducing the timespan between drug development and marketing stages. Clinical trial intends to answer research questions through data generation, to disprove or prove a hypothesis.

Generated data's quality is a crucial contributor to the study's outcome. CDM denotes subject data collection, management, and cleaning, according to regulatory standards. CDM processes' basic aim is providing superior quality data, through minimization of missing data and errors to the maximum possible extent, and gathering maximum possible information for analysis. Maintenance of audit trials of CDM activities is extremely important in case of regulatory submission research. CDM tools guarantee this audit trail, while concurrently managing any discrepancies that crop up (Krishnankutty, Bellary, Kumar & Moodahadu, 2012).

When the phase of clinical trial is reached, data, application and information access from one single source helps save an enormous amount of time as well as effort. This is the function of Perceptive MyTrials by PAREXEL. The proprietary platform of Perceptive Informatics simplifies clinical trials' utilization of software, through an application system that facilitates easy access of its integrated clinical trial program suite. Perceptive MyTrials links to a cloud applications suite, for accessing multiple programs, data, and trials, using a single credential set.

This smooth, efficient, and scalable technology makes the most of integrating data and applications on to one platform via a dashboard as well as reports, which constantly update metrics and status, for a complete view of research progress and performance (Perceptive Informatics, n.d). Perceptive Informatics employs DataLabs' Electronic Data Capture (EDC) solution, which concentrates uniquely on simplification of workflows and high-quality user experience delivery.

Its superior EDC features assist with streamlining the whole process, right from the research design phase to data collection, reporting, and management, in the clinical trial phase. A number of trials still employ paper-driven procedures, while sites and sponsors have progressed forward and adopted EDC. The application by DataLabs offers one single electronic CDM platform for unifying paper-based data entry's functionality with EDC's flexibility. The one-of-a-kind hybrid feature allows site inclusion option to researchers, through paper CRFs (Case Report Forms), while supporting already existent paper processes.

Data capture technique can be changed anytime during the research. Unique convergence of product between ClinPhone's Randomization and Trial Supply Management (RTSM) and DataLabs' EDC applications enables performance of real-time dispensation and randomization activities by site users, directly through EDC, without logging into Interactive Web/Voice Response (IWR/IVR) systems. The close interoperability with RTSM provides great simplification of workflows for sponsor and site users.

The on-demand, SaaS (software-as-a-service) application, priced based on subscription, profits clients through efficient, rapid deployment of EDC with low upfront expense and system investment, and no continuous maintenance issues. DataLabs' EDC offering implies absolute flexibility and easy use for clients of distinct sizes and types (Perceptive Informatics, n.d). Several small barriers are encountered by clinical investigators,.