What are the needs of medical device companies when it comes to eCRF and EDC systems?
At the end of 2013, the European Union passed legislation for a new approval process of medical devices going to market that mirrors the process in place by the FDA. The European Union has responded to recent medical device scandals, for example the breast implant incident in France which claimed several patient lives, and is pushing for regulations that increase patient safety. ARITHMOS discusses an eCRF solution to support medical device companies.
To give a brief outline of the changes:
(1) The equivalence principle will no longer be admissible. Companies can no longer simple demonstrate that a device is equivalent to another device already on the market. Medical device companies will need to perform more sophisticated trials and collect additional data to demonstrate efficacy and safety.
(2) The EU is proposing more post-market follow up studies and safety surveillance
(3) Similar to drug trials, the EU is also pushing for greater data transparency meaning trial data needs to be available in a clear, reliable and traceable way.
For medical device companies, this proposed legislation means more trials and additional costs.
Which technology solutions can help medical device companies stay within budget and still obtain high quality data results in real time?
Technologies such as EDC and ePRO can help keep costs under control, especially if there are low-cost options. Incorporating an EDC solution into your medical device trial can provide immediate feedback, more accessible trial information, and higher data quality. It can facilitate an adaptive approach, or in the case of a trial that is showing a negative trend, it can allow for early termination, thereby reducing the risk to patients and reducing the cost of the trial.
An EDC solution provided in Software as a Service (SaaS) cloud computing mode can improve the medical device development process in terms of greater efficiency, a better decision-making process and cost-cutting measures. Health Sciences applications allow users to only pay for functions they use and to re-use certain applications for various projects.
How can a SaaS solution benefit medical device trials?
– Sponsors can resolve discrepancies faster and reduce time and costs with immediate feedback from patients. Data can be transferred in real time during the study and query management is accelerated.
– A cloud solution can organize multi-language, global study data into a single database. This is especially beneficial to statisticians who need up-to-date study metrics.
– Improves the quality of data through automated edit and discrepancy checks, faster data cleaning, audit trails and compliance with GCP and regulatory guidelines.
The ARITHMOS Solution
ARITHMOS has a SaaS, cloud based platform called Symphony EDC, who possesses the basic functions of an EDC system that satisfy the normal requirements of Investigators. Symphony is a customizable Life Sciences Application which provides the following advantages for medical device companies:
– Paying for the functionalities needed and not paying for those not applicable to your study
– Ability to reuse the application with slight modifications
– Reuse of documentation
– Training effort kept to a minimum due to high usability
– Sponsor and site personnel use the same application for different projects
ARITHMOS to Host eCRF Symposium in Italy
ARITHMOS is hosting a symposium on eCRF requirements for institutions such as medical device companies, academic research organizations and hospitals. The symposium will present affordable and reliable eCRF solutions as Software as a Service.
The event will take place on Thursday, 10th of April at the University of Milan-Bicocca in Milan, Italy.
For more information, visit our website.
Medical Device eCRF Needs Focus Group
ARITHMOS is currently looking for professionals in the medical device sector to participate in a focus group on the current eCRF and EDC needs in medical device trials. We are looking for professionals in Europe or the United States who are involved in the CRF design and implementation for medical device trials. Participants can connect to the focus group remotely. If you meet the criteria and are interested, please send an email to email@example.com.