Traditional EDC is built on an outdated vision for clinical data collection.
Clinical activities for MedTech are as different as the devices are many.
Because of the EU MDR and IVDR, the need for an industry specific solution to reduce the workload and cost of clinical operations has never been greater.
Medical Device studies often require small adjustments in study designs depending on countries and EC approvals.
ISO 14155:2020 and MDR compliant AE reporting. Packed with ready to use customisable templates
Enables quick and validated study setup that empowers clinical teams to be in full control of their activities.
If your study subjects require one or many treatments with your device, you can use multiple activations for any visit event.
It's not only about features. As an EDC vendor we need to provide the right guidance on your clinical data strategy.
With over 7 years of experience working with Medical Device manufacturers, we possess valuable know-how that is mirrored in our services.See white papers »
Developed in close cooperation with clients and MedTech partners, the product team takes great pride in releasing four validated updates to SMART-TRIAL every year.
By implementing features that adhere to Medical Device manufacturers, we are building a long-term solution to fit the future of the MedTech industry and its regulatory framework.
SMART-TRIAL's goal is to become a part of the continuous clinical evaluation process and simplify the compliance part.
The platform, professional services and licensing is designed to fit medical devices.
We deliver ready-to-use templates and QA files that are designed to ensure that you can be compliant with industry requirements, such as ISO14155:2020, FDA CFR21 part 11, GDPR and more.