Over 50% of clinical trials are still carried out using spreadsheets or paper, which will be impossible to sustain in the post-EU MDR era, since the new demands for technical documentation are much stricter than previously. Therefore, we expect to see more and more manufacturers moving their research and post-market surveillance (PMS) activities into the cloud. But EU MDR conformity isn’t the only advantage of switching to an electronic data capture (EDC) system. Our latest Infographic offers you six good reasons why an EDC system for your clinical validation and PMS/PMCF processes is clearly superior to paper-based trials.
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What is the EU MDR?
From May 26, 2020 onwards, medical devices manufacturers operating and/or selling within the EU must comply with the EU MDR (EU 2017/745). The regulation’s objective is to improve patient safety by evaluating existing devices (e.g. through PMS and PMCF) and ensuring transparency throughout a device’s lifecycle. You can read the full regulation here.
New demands for your technical documentation
One major new demand of the MDR (Annex II) is that manufacturers’ technical documentation must be presented in a “clear, organized, readily searchable and unambiguous manner”. Until now, many affected companies have been working with unstructured, inflexible data collection and sharing systems, such as paper, Excel or email. Since these systems 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.
Free Infographic: Six reasons for digitalizing your clinical research and PMS
The new regulation isn’t the only reason for going digital with your technical documentation. Our infographic “Going Paperless in Clinical Trials” offers six reasons for moving trials and post-market surveillance into the cloud. Not only will this help you become MDR compliant, it also offers benefits such as:
1. You’ll save valuable time
Many of the clinical data capture processes which would take a long time on paper can be fully automated with an electronic data capture (EDC) system. In the event of unannounced audits – which will become highly likely under MDR law – paper-based firms will find it challenging to retrieve certain data and/or files on time.
Furthermore, research by medidata and Abbott shows EDC systems can reduce study close-out cycle times by 75%.
Climedo references show that study documentation time can be reduced by 50% and onboarding time can be reduced by 80% with an EDC.
2. You’ll cut your costs
Although paper-based studies may not require a regular license fee, they are significantly more expensive in the long term. For example, the high error rate resulting from manual data entry is likely to be much more costly compared to the cost of an automated EDC system.
Studies show that the long-term cost of paper-based trials and validation processes is actually up to 49-62% higher*** than it is for cloud-based solutions. An EDC solution also means fewer site visits and fewer monitoring queries compared to paper.
3. You’ll end up working with a much more secure solution
Despite popular belief that storing clinical trial data on paper is more secure than having it on a server, paper still needs to be physically moved from one site to the other, posing major security risks. Some data needs to be stored for up to 15 years, which will prove difficult – and unsafe – if managed on paper.
Using an EDC for trials is a much safer solution, providing it is implemented using the highest level of data security (ISO 27001, HIPAA), data pseudonymization, offsite backups, and SSL encryption.
4. You’ll prepare your staff for the digital era
Although paper-based studies may not require much training, the investment in upskilling staff to use an EDC solution is well worth it when considering the long-term gains. For example, learning to use Climedo requires just 2-3 hours on average.
With the industry’s accelerated shift towards digital transformation, it is crucial to train one’s workforce in the usage of cloud-based solutions. Not only does this help develop personnel, it also shows prospective talent that a company invests in its employees to equip them for the digital age.
5. You’ll offer patients more support and empowerment
A holistic EDC can significantly improve patient care and empower trial subjects to have a say in devices’ efficacy. Seriously ill patients often miss site visits or forget to use a device if they are only communicated with “offline”. Integrated ePRO / eDiaries with scheduled reminders allow patients to report comfortably via email or SMS, thus resulting in a better recall rate.
If doctors can cut the time spent on data entry, they are able to take better care of patients. Studies show that when healthcare providers make patients feel understood, patients are more likely to follow their advice, thus improving therapy outcomes.
6. You’ll get completely new data insights
Data virtualization can offer unprecedented insights when it comes to clinical trial data, and help companies make informed business decisions. For example, combining and integrating clinical data from different sources can help highlight potential new abilities of medical products, develop new marketing claims and alert firms of safety risks more quickly.
Companies will also be able to see in real time which clinical trial sites are potentially underperforming, performing particularly well and/or require action.
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Want to see a cloud-based EDC solution in action? Contact us for a free software demo!
Additional downloads to get you ready for the EU MDR
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