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, money, reducing manpower and incidences of human errors with the help of strict controls set within the software to avoid any errors and wrong entries.
Software like BizNET-CTM had already made the regulatory reporting so effective with audit trails. Various review flow has also made it one of the preferred software for managing many BA/BE or clinical trial studies all at once. It gives respective controls to respective department to do their job at various level and time, the same being monitored by Quality Assurance Department for every entry and edits if made.
Compliance and Regulatory requirements in clinical trials has made the entire cycle so cumbersome when it comes to do produce all hard copies, so the same has been replaced with softcopies with very less hard copies for the quick process of the delivery of report and review processes.