This software is meant to tackle the challenges posed by paper and hybrid studies. The challenges include the time spent, the costs and the likelihood of incomplete or inaccurate data from the study.
The rationale behind the design of clinical study software is to conduct and plan all phases of trials in order to achieve sequential test designs. The software should be professionally validated by the relevant authority and comply with all the requirements to allow reproduction of certain adaptation rules and procedures. Further, it should combine the vital features of conducting and planning a clinical trial that is sequentially planned within a user interface that is friendly and interactive.
The following thereof are the essential requirements the software should be able to address:
– The software should be flexible enough to combine all the clinical research phases and the enrichment designs for the patients
– A number of comparison and assessment procedures for a broad range of adaptive trials;
– Have the capability to simplify all the processes involved in the sharing and management of huge volumes of data.
The software should have the capacity to incorporate a wide range of activities, these activities include:
– Study set up;
– Investigation selection;
– Management of finance;
– Recruitment of samples;
– Monitoring data and results;
– Analyzing data and results;
– Collating data and results.
All the above processes and activities will be made easier with the study software. The software will assist you to collate and collect data in a daily basis and organize it in a fashionable manner to allow easier of retrieval and quick analysis and transfer of the same data.
Why use clinical study software
As stated earlier, this software is there to solve the problems posed by paper studies. There are a number of reasons why you should use study software and the reasons are outlined in the section below.
– Paper studies are not friendly to the environment and it is out dated. If 75% of all clinical trials and studies are going to be conducted using paper, then it means that in the United States alone, around thirty thousand trees are going to be cut so as to supply the required amount of paper in one year. This will lead to massive cutting of trees to quench the demand for paper.
– Paper study is inefficient and slow as compared to study software, which is fast and efficient. You will require a lot of effort and time to enter data—and manage the discrepancy of data and produce the results. The process is likely to have a number of flaws leading to having inaccurate results. In addition, the process of reacting to any flaws and discrepancy noted will be slower consequently affecting negatively the process of data study.
– Paper study process lacks security. You have limited alternatives at your disposal to protect the study information.
Besides the inefficiencies of paper study, a unified database will not help you in your clinical studies because of the following reasons hence compelling you to have study software for accurate results.
– Comparing a unified database to a study software, a unified database is expensive to license the entire front end and back end processes, it requires upgrade fees and continuous maintenance fees.
– Electronic data capture has no control. This is a big shortcoming for study managers because for them to have some control on the database, they have to go through with programmers in studying every aspect of the database.
– A unified database requires significant IT resources for proper training, planning and storage of support servers.
Features of clinical study software
– The software should be easy to use with an intuitive, clean and interactive user interface
– It should be easily accessible by any web browser across the globe with no any installation requirements and programming on your machine
– It should be a flexible software that needs no vendor lock in and designed in such a manner that it is easier to add more functionalities
– It should be cost effective to acquire it
– It should be a trusted software with credible referrals; and
– Have the capacity to support complex processes and demonstrate the ability to enhance process development.
Overall, clinical study software should have the capability of simplifying the process of sharing and managing large volumes of data.