Advances in IT combined with business model transformation could combine to form a critical step in attaining transformation of the Clinical Trial Enterprise through lower cost, faster, and better data excellence of clinical trials. The entities involved in the conduct of clinical trials have not followed the cost-reduction route of other technology-intensive industries and thus have not attained a business transformation adequate to gain the economic benefits of technologic adoption.
An Electronic Data Capturing (EDC) or Direct Data Capture (DDC) for collection of clinical data through computerized system helps accelerating and streamlining the data collection method by replacing the traditional paper based CRF, in an organized and standardized process. But mapping raw Electronic Data Capture (EDC) data to a Study Data Tabulation Model (SDTM) or Analysis Data Model (ADaM) standard is a very time consuming process.
It has become a practice now to avoid data slip through cracks, where CROs have been continuously evolving by moving towards technology as a solution for their data capturing from scratch to the end report. Recent findings in tech world has highlighted the power of machine learning algorithms and their impact on Clinical Trials company assaying bigger capabilities to ensure data integrity and quality.
Recently the term “biometrics” has gained much attention in Clinical Trial (CT) studies during registration of volunteers at sites. Contract Research Organizations (CROs) where the record is finespun for human population. Registration of volunteers for Clinical Trial project with due care and distinctive is one of the chief aim of the CROs.
Biometric technology has coined a great high-end solution for creating unique identifiers for the Subject population being enrolled in clinical studies. So, in Clinical Trial world by adopting this Iris scanning leads an added option along with the other existing biometrics/OVIS (Online Volunteers Information System). IRIS has helped a lot in avoiding dual registration and miss-matching of the volunteers for clinical study.
Extensive use of electronic gadgets and software as a management and reporting platform in compliance with 21 CFR, part 11 has increased many folds in Clinical Trial industries. Managing screening of the population, electronic data capture etc.Is available at finger tips. Entire management from scratch to the end reporting has gained momentum in terms of saving time,
Clinical Trials has indeed evolved over the years. How electronic records have taken place over hard records. Software and hardware solutions have gained much attention and have really worked well from the scratch to the final reporting for BA/BE and clinical trial and other studies. Clinical development has become better and the same can be experienced with BizNET-CTM.