subject: Mobility in Pharmaceutical Sector [print this page] Mobility in Pharmaceutical Sector Mobility in Pharmaceutical Sector
Drug Discovery
The main step of the drug discovery process is the Target Discovery in the research laboratories, which identifies proteins that cause a specific disease condition & the compounds that negate its effects. Research laboratories & facilities are geographically distributed. This distributed environment make the data collection and integration a herculean task. Data is also in multiple formats including handwritten notes which creates enough error opportunities and also increases the manual work of entering the handwritten notes.
An application on the mobile phones/tablets will allow for immediate data capture across a distributed environment and also reduce errors which would have occurred on account of manual entry (misinterpretation of handwritten notes). Given the criticality of the data in the entire drug discovery cycle such an application will improve the efficiency of the process by leaps and bounds.
Drug Development
Clinical trials are the most time consuming aspect in drug development. First, a clinical trial is inherently distributed, involving multiple sites and players who are on the move. Most often the process of collection, analysis and validation of patient clinical data is manual thereby compromising the accuracy and reliability of the data.
Second, trial investigators must perform a variety of administrative tasks, all in strict compliance with protocol and guidelines which are not always easily accessible. Investigators must understand and observe a plethora of strict rules for trial management and compliance with regulations. They must perform a variety of tracking tasks and fill out paperwork for patient screening and enrollment, drug usage, budgets, supplies, CRFs, adverse events, biological samples, etc.
Mobile applications allow administrators & participants to communicate at will, sync and transmit data and documentation (CRFs, drug logs, etc.). Appointment scheduling, notes & calendar sharing improve communication without the need to access desktops. Data transmission for analysis, reaction & trial adjustment to the central repository is immediate. It provides investigators to-do lists and guides to trial rules and management. This is done through alerts set on the mobile devices, and automate the production of audit trails through data and time stamping to comply with regulations.
Mobile applications can manage variety of trial documents (protocols and potential violations, clinical practice tutorials, rules for sample handling, inclusion/exclusion criteria, annotated CRF templates) on mobile devices for easy reference. Applications assist investigators to perform tracking tasks like form creation for patient screening and enrollment, drug regimens, ordering supplies. It prompts patients to record required clinical data and information in prescribed, common, electronic formats.
