Top 7 common pains experienced by clinical data managers when dealing with EDC

A great majority of tech companies have been forcing their solutions into the market with the notion of fulfilling a particular need. But the real reason behind every product’s success is its ability to solve clients’ pain points.

Nowadays, only the most innovative and forward-thinking market players know that understanding the customers’ pain points is a major factor in the overall value chain. 

There is a wide range of existing EDC systems in terms of management structure, features or support. However, 86% of survey participants said that they are not completely satisfied with the solution proposed by their eClinical vendor. A questionnaire was carried out by Data MATRIX among 200 respondents, including data managers, monitors and researchers, to collect the major concerns from CROs and pharma staff members who have worked with different eClinical solutions providers. 

These are the most frequently addressed issues on our list so far:

  • 78% — Inconsistencies and downtime. Two thirds of respondents have indicated discrepancy, long set-up stages and all further extensive procedures as the most-common concerns when dealing with EDC. In terms of EDC and eCRF, the inconvenience of a system may be caused, for instance, by editing, designing and commenting on the eCRF versions created externally.

  • 67% — Non-customizable. Inability to adapt or alter the default interface of the system, e.g. change fields, add formats, etc. Indeed, EDC systems are frequently non-customizable, may not fit into the workflow, and have been considered inadequate in the context of the needs of particular clinical research.

  • 52% — Complicated integration. Most  EDC developers do not provide  means for seamless integration with third-party solutions, hence  increased downtime, i.e. it may not be possible to merge data exported out of an outside module provider (e.g. ePRO) with EDC.

  • 49% — Limited report exporting. Many will agree that it is quite convenient when there are several report exporting options besides .pdf format. To this can be added a report templates library, reporting management adjustment, easy-to-use designer, etc.

  • 34% — Non-cloud based solutions.  Clinical trials industry players tend to agree about the time and cost-saving benefits of this approach. Therefore, the majority of research sponsors are looking for cloud-based built-it yourself solutions. 

  • 20% — Complicated system or lack of defining roles. An advanced and flexible EDC follows a dynamic approach to role-based access control among study participants. All roles (Investigator, Sponsor, Monitor, Data Manager, or any other) are provided with  a separate login to access and meet specific needs of a study and are involved in the process via the proper EDC authorization process.

“The future of eClinical depends on the collaboration of developers with end-users such as data managers, monitors and coordinators. To deploy sustainable and future-proof eClinical solutions, we have to map out key users’ pains and be extremely responsive to them. This is the reason why we are so excited to get market feedback on the existing eClinical tools” — stated Alexandr Yakovlev, Director of Software Development Department at Data MATRIX.

The survey findings confirm that even a wide variety of eHealth solutions do not solve all users’ concerns. As the industry is keen on moving towards cost-efficient and user-centric clinical trials, eClinical solutions continue to look more appealing and valuable to sponsors. Moreover, the right EDC system is not just a user-friendly tool for data managers,but a great solution for obtaining high quality data, make accurate, real-time decisions, accelerate all the processes and reduce the time and costs of studies.

22 August 2019

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