A new test product and treatment both aren’t sold in the market directly. Before the sell, it needs to be tested on research subjects for efficacy, safety, tolerability of different dosage forms and diseases studied for this whole process is called a Clinical Trial.
In the whole process of conducting clinical trials there are some necessary approvals required from the applicable regulatory, IRB & IEC, number of subjects participated at the different site, no. of staff involved in operation and arranging for large amount of data generated before the study is initiated.
Traditional v/s. Newer methods of conducting clinical trials
After the conducting of clinical phases, the generated data has been entered in the paper forms. All the details of the activities have been captured on paper forms which are designed as per the Protocol and it would be maintained in the form of study data file.
But trends have changed because of digitalization; even the regulatory authorities also want digital reports. In this case the software will help to Planning, Managing, Conducting, Performing and Reporting function and tracking every activity in computerised format. And help to more for efficient patient care.
Safety of Participants
Clinical trials are sensitive process because it is carried on human beings and safety comes first and foremost, a minor mistake can be disastrous. Also, the regulatory authorities play vital role in review & monitor the results of trials.
Which makes digitalization of utmost importance for enhanced patient safety and care.
Planning & Management of the Study – Before initiation of the study we can make proper plan to conduct the study by using software
Data output – A legible, neat & clean, accurate data should be generated and electronically captured in the software – maintaining all round data integrity.
Error Free Data for Audit – capture end-to-end details of each activity electronically; there being less possibilities to make mistake
Different Type of Studies – Handle multi-phase, multi-design, randomized control, blinded- unblinded, multi-centre or multi-site study
Know the Status – Patient safety issue & project status activity can be easily tracked
Regulatory Compliant – Data is the mirror of every activity and the software need to be compliant with 21 CFR ICH-GCP (E6) R2
Patient safety and efficient care is one of the most important criteria in any clinical trial followed by achieving successful regulatory inspection.
Sarjen Systems Provides End-to-End solution for Clinical research platform, BizNET, contributes unique function to manage clinical trial activities and also interlinks with the different modules like IMP Track to manage pharmacy activities, Biolyte for the Bioanalytical analyses, LIMS for Sample Management activities, Smart R for conducting multi-visit randomized control study and SDTM for report generation In CDSIC format for US FDA.