| Drug manufacturing and marketing companies are | | | | regulatory authorities, ethics committees and other |
| constantly monitored by regulatory bodies that have | | | | stakeholders. |
| stringent rules on manufacturing processes, marketing | | | | Investing in a fully automated safety-to-investigator |
| messages and adverse events reporting. So, it is vital | | | | system significantly reduces the time and the |
| that drug companies keep the channels of | | | | resources needed to collect, manage and distribute |
| communication open, when it comes to dealing with | | | | safety documents. It cuts back on costs and |
| regulatory authorities. | | | | overheads which can be directed to the development |
| There is a need to constantly update investigators | | | | of better drugs or other biological products. |
| on safety issues pertaining to the drug development | | | | Most of these pharmacovigilance systems that send |
| cycle and the aftermath as well. This is a | | | | out safety reports to investigators are developed |
| labor-intensive process that requires the use of a | | | | from the investigator's perspective. Hence, the |
| tremendous amount of resources as safety concerns | | | | documents are easy-to-comprehend and up-to-date, |
| need to be printed and processed before being | | | | at all times. |
| handed over to investigators. | | | | When it comes to Adverse Events Reporting, these |
| However, with the development of information | | | | automated systems are crucial to the smooth flow |
| technology, drug companies are these days choosing | | | | of information. The reports sent out help |
| to employ automated safety-to-investigator | | | | investigators keep track of any adverse effects of |
| technologies that save heavily on time and money. | | | | the drugs even after they hit the market. Also, in the |
| These automated technologies enable drug | | | | case of signal detection, the system helps |
| companies to automatically monitor, track, process | | | | investigators and regulators keep tabs on the |
| and manage the distribution of clinical safety reports | | | | processes undertaken to rectify the adverse signals. |
| and relevant documentation to investigators, | | | | |