For clinical research managers who have always conducted their studies on paper or using spreadsheets such as Excel, there is sometimes a level of distrust towards cloud-based solutions. The cost of electronic data capture (EDC) subscription and ePRO solutions can appear intimidating at first. In addition, many are hesitant to commit additional time and money towards workforce training in new software systems.
A new level of technical documentation under EU MDR law
According to Annex II of the EU MDR (Medical Device Regulation 2017/745) which must be complied with from May 26 2020 onwards, medical device manufacturers’ technical documentation must be presented in a “clear, organized, readily searchable and unambiguous manner”. Since systems such as paper or spreadsheets are cost-inefficient, unsafe, and likely to struggle in the post-MDR era, we can expect a surge in companies moving their technical documentation into the cloud – and this includes solutions such as EDC and ePRO (electronic patient-reported outcomes).
Studies show that electronic participant reporting in clinical research yields higher quality data and better participation rates than paper-based diaries. As the world shifts towards a focus on patient empowerment, self-reported data by patients will play an increasingly important role in clinical data collection. ePROs, as the name suggests, are electronically collected patient-reported outcomes. Research shows that ePRO elicits a significantly greater subject compliance, sometimes as high as 97%.
What are the advantages of ePRO and EDC solutions?
So, if you’re on the fence about choosing an EDC to conduct your clinical trials in the future, consider the following advantages of ePRO and EDC for managing studies rather than spreadsheets and pen and paper.
1. Improved regulatory compliance and a trackable audit trail
An audit trail that details the reasons for change throughout your data collection is a powerful part of maintaining regulatory compliance. In the EU MDR era, no device class is exempt from maintaining up-to-date pre- and post-market data collection for acquiring and keeping its CE mark. Many EDC systems and ePROs have an audit trail feature, while paper-based and spreadsheet often make it difficult to track data changes. EDC systems that have been validated by a third-party audit can help eliminate any concerns you may have about the compliance of your data.
2. Error detection and prevention thanks to ePRO
Data entry mistakes resulting from human error are inevitable, but edit checks are completely absent in paper-based data collection methods. Although Excel formulas offer an elementary level of validation, missing or incorrect data may still be overlooked. This can result in the loss of significant time and resources in larger scale studies. Reading patients’ handwriting on paper forms can also be a struggle, so allowing them to enter their data electronically through an ePRO or eSurvey will significantly speed up the process and allow for data to be fed directly into the system, rather than manually entered by medical staff. EDC systems also enable you to incorporate conditional actions directly into eCRFs, firing queries and sending targeted notifications when any user-defined event has occurred, such as (serious) adverse events, new enrollments, or protocol deviations.
3. Flexible Reporting Options
Manual reporting is a huge drawback of paper-based data management. The more complex the report, the more difficult, time-consuming and costly the corresponding resources you’ll need to invest. EDC solutions such as Climedo can help create automatic skip patterns, restrict the range of possible responses, and set automatic filters on answers to apply exclusions / inclusions etc. This level of assurance cannot be achieved with a paper survey or using spreadsheets, where the breadth and depth of reporting options is limited. Once built, eSurveys and eDiaries can be modified and reused in multiple formats, saving you time on an otherwise tedious task.
4. Enhanced Data Security
Potential data security risks represent an understandable concern across the clinical research industry. Advanced EDC solutions provide role-based security functionality, making permissions and user roles highly configurable to ensure that only authorized people within the study have access to the data which is relevant to them – a functionality which is close to impossible with paper- or Excel-based questionnaires. Furthermore, EDC is one of the safest solutions for clinical research, providing it is implemented using the highest level of data security (ISO 27001, HIPAA), data pseudonymization, offsite backups, and SSL encryption.
5. Multi-user and multi-role simultaneous data entry
Paper-based solutions do not allow multiple stakeholders to work with the same data simultaneously. Further, operating with multiple spreadsheets, documents, and versions can lead to discrepancies and misplaced data. A cloud-based EDC empowers several team members to manage data at the same time. Users can benefit from realtime tracking and viewing, which is virtually unachievable via spreadsheet or paper. With an ePRO solution, study subjects can also electronically access forms and input their data, thus giving them more control over their study participation and creating improved patient engagement.
6. Enhanced ePRO capabilities
Data management with Excel or on paper means that you’re only capable of simple data entry and revision. Climedo’s EDC and ePRO solutions offer you access to a wide range of functionalities such as randomization, scheduling, product tracking, normal lab ranges etc. Not only do these enhance the level of reporting, but also allow data analysis results to feed into company strategies, ranging from clinical development to powerful product marketing claims.
If you’ve ruled out electronic systems such as EDC and ePRo in the past due to budgetary constraints or fear of extensive training hours, Climedo can help remove these barriers and pave the way to more efficient clinical trial data management.
Our flexible pricing structure and intuitive user interface make us an ideal partner for companies and researchers who are new to EDC. Training and online support are also provided and will help to shorten the learning curve substantially. In light of the upcoming EU MDR deadline, there’s no better time than now to start collecting compliant, higher quality data. Get in touch to book a free, personalized software demo.