| The importance of clinical trials to the world of | | | | procedures may be simple and a company could |
| medicine cannot be emphasized enough. They are | | | | use an in-house program. But later when the |
| necessary to ascertain the quality as well as the | | | | scope and complexity of the trial management |
| ability of drugs to be safe palliatives and curatives | | | | program increases, it would need a sophisticated |
| for a host of ailments and human illness conditions. | | | | management that takes into account the various |
| Whether a drug is safe for human usage and | | | | aspects of financial management, communication |
| treatment is determined by these trials, which are | | | | and time management for effective clinical trials. |
| conducted over animals and then on humans too. | | | | So, more stable and feature-rich software |
| Clinical trial management systems are specific | | | | programs are used at the advanced stages to |
| modes of software systems of managing the | | | | take care of a host of requirements like patient |
| huge amounts of data and culled information | | | | management, budgeting, compliance with the |
| related to these clinical trials. | | | | regulations laid by government and compatibility |
| A CTMS (Clinical Trials Management System) | | | | with some other data management systems. |
| takes into account the preparation, performance | | | | CTMS can have specific modules that record and |
| testing and reporting of clinical trials. There are | | | | document patient registry, patient study |
| various sub-parts and sub systems in the trials | | | | calendars, clinical data records and adverse event |
| that need to be tracked and monitored so as to | | | | records. The system is a happy amalgam of |
| meet the deadlines, conduct tests, file for | | | | biotechnology and pharmacology with the liberal |
| approvals, follows ups and a host of other | | | | use of information technology. A number of IT |
| important scientific, administrative and legal | | | | companies have built highly complex integrated |
| functions and even some of the sub-functions. In | | | | clinical trial management systems for seamless |
| the initial stages, the number of tests, steps and | | | | coordination of various aspects of clinical trials. |