eSource is starting to gain traction with the increasing implementation of novel technologies in clinical trials faces cultural barriers at biopharmaceutical enterprises. Operations demonstrating the generation of data have been streamlined to a larger extent with the impact produced on clinical operational productivity. The utilization of eSource on workload reduction at study sites will have to uncover several breakthrough trends including eSource solutions providers, clinical Ink and applied clinical trials raw data from relevant site impact survey for analysis.
The evaluation of clinical research coordinator and investigator experiences has had a great impact on the design process by clinical Ink which is linked with the eSource system when compared to the paper source. Surveys related to clinical ink research coordinators and investigators revealed the usage of Sure-source in clinical trials and therefore the received responses will be analyzed based on the respective eligible individuals. Then the comparison differences will be carried out in relation to the paper-based studies and trials using eSource. Maximum utilization of statistical assessments and confirmed statistical fit through chi-square models tend to be overlooked upon the results of the multi-factorial analysis.
Data analysis and results are considered to be an important source to extract the overall workload which is believed to be the functionality of edit check feature. It actually allows the program to minimize the malicious errors. With the support of validation functionality, the data acquired would suggest a minimal reduction in the workload. When compared to paper trials the easiness in workload shall be achieved by the perceived results in sure-source. Electronic formats are found to be much easier to comprehend and the visualization can be projected with paper forms presentation. Various colored marks are used for emphasizing the various elements such as quality, data entry, and validity. Most of the data entries in a particular eSource also get efficient paper studies as opposed to the least demonstrated user reduction workload. Predominant eSource entries should have to adhere to realized data efficiencies that are recorded on paper forms. Further, the data entries would be analyzed with respect to the existing data in EDC. One of the significant features of eSource entries are, the sites would need to enter data only once. By doing this way, the repercussions and repetitions corresponding to selective data could be avoided.
Quantitative research act as the face of the opportunity to investigate and confirm positive trends with eSource utilization in clinical operational workload reduction compared to paper-based trials. Several studies have been carried out for the better understanding of trends that are in existence. In addition to reducing clinical trial workload with sure-source, the studies have also unveiled the realization of possible ground benefits such as eliminating data re-entry into EDC and addressing issues in real-time while the patient and study staff are present. “Sure-source also stops the triplication of work and makes the data to be entered directly into the system while the patients are still with their charts and PI will be available to address issues”, revealed Donna Straaatman, RN, BSN, CCRC and clinical research coordinator at Mercy health system. Sure-source has been playing a great significant role in the evolution of eSource and its impact on data in such a way that, it saves at least 30 percent of time for the clinical coordinators and allow to focus on involving in multiple tasks such as spending more time with the patient during visits, recruitment efforts, and observing more patients.
Another noted benefit include the usage of smart electronic source documents which is apparently the first real-time data stream which leads to the elimination of electronic data transcription and the myriad of queries that the paper process generates. It also helps minimize the workload of a site by the inclusion of “front loaded” feature and thus eliminating “backend” work.