Streamline MDR and IVDR Clinical Operations with the First European MedTech eClinical Suite

March 2, 2021
in
 - written by 
Jón
Bergsteinsson

SMART-TRIAL (DK) and BSI Life Sciences (CH) today announce a unique strategic partnership to help MedTech companies streamline their clinical operations. Together, the two eClinical software vendors offer the first European-based eClinical software suite, tailored to the MedTech industry. This new interoperable eClinical suite will enable all Medical Device manufacturers to have the overview and control needed to run efficient clinical operations to comply with the EU MDR and IVDR.

Seamless integration of SMART-TRIAL & BSI Life Sciences platforms

With increased requirements for clinical data under the EU MDR and IVDR, MedTech companies find themselves forced to re-evaluate their clinical strategy. The sudden influx of new clinical activities places an immense pressure on existing operations - especially for organizations who had minimal or no clinical operations before.

In the coming years, the number of both pre and post market clinical investigations is expected to increase considerably. With an increasing number of clinical activities the need for better overview and control of clinical operations is vital to ensure compliance and optimal use of existing resources.

MedTech Clinical Operations are Different

Traditional eClinical solutions are built on an outdated vision for clinical trials in the life science industry. As medical technology advances and becomes more sophisticated, the need for data to demonstrate efficacy and safety increases. Clinical trials are no longer a unique process for pharmaceutical products. They are becoming a standard across all areas of the life science industry.

While pharmaceutical trials are often similar in design, medical device investigations can highly differ from one device to another. Disregarding the difference in clinical endpoints or statistical testing between devices and medicinal products - the application of devices and medicine in practice is also vastly different. This places a unique challenge on eClinical vendors, because most of the traditional eClinical solutions have been designed to solve a problem for pharmaceutical trials. Thus, the flexibility and dynamic operability needed to support MedTech clinical operations is non-existent.

Around 95% of the EU MedTech industry are SMEs with considerably lower budgets than many of the big-pharma companies. But pricing of existing eClinical solutions is designed to adhere to pharmaceutical budgets. As such, medical device companies have found it difficult to transition to complete digital clinical operations, due to the tremendous high startup costs.

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.

Five Ways a MedTech eClinical Suite Helps with MDR/IVDR Compliance

The need for electronic data capture and eClinical Suite solutions is vastly increasing as the MDR & IVDR compliance deadlines are approaching. But how can an eClinical Suite help MedTech companies ensure simplified and compliant clinical data gathering and management?

Read more  in our new whitepaper:

Five Ways a MedTech eClinical Suite Helps with MDR/IVDR Compliance


Electronic Data Capture (EDC) Made for Medical Devices

With over eight years of experience supporting Medical Device manufacturers, SMART-TRIAL offers the MedTech industry’s leading EDC platform. SMART-TRIAL’s data collection tools range from electronic Case Report Forms (eCRF) to electronic Patient Reported Outcomes (ePRO), Surveys and Case-series for PMCF.

Being the first and only tailor-made EDC for MedTech, SMART-TRIAL has gained a strong foothold within the MedTech industry on both sides across the Atlantic. Today, SMART-TRIAL is used by both large and small enterprises to collect and manage data in all types of clinical operations around the world. By working closely with all clients, experience gained from supporting MedTech studies for the past eight years, is mirrored in all its services and the company’s innovative approach towards data collection.

With a validated and user-friendly platform all MedTech companies can set up and manage clinical studies by themselves, to collect high quality data in compliance with industry regulations. By now integrating with the CTMS and eTMF from BSI Life Sciences, all SMART-TRIAL clients can now implement a complete eClinical Suite to further enhance their operations.

Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) with Swiss-Grade Quality

BSI has created software for 25 years. With its roots in Switzerland and international presence across Europe and USA, BSI Life Sciences offers a modern CTMS and eTMF solution for the MedTech industry. Both the CTMS and eTMF are feature rich platforms that are used by both traditional and diagnostic device manufacturers across Europe and North America.

From study design and trial management to monitoring, trial supply and financials, the CTMS from BSI Life Sciences can offer everything you need to manage your clinical operations through a user-friendly interface. The eTMF is an integral part of the CTMS and offers sponsors the possibility to manage and keep control of all study documents in one digital universe.

Together with SMART-TRIAL, the CTMS from BSI Life Sciences can streamline overview and reporting through live data integration. The need for manual reporting processes and migration of data between platforms is no longer an issue.

Learn How to Get Access to the Complete MedTech eClinical Suite

SMART-TRIAL and BSI Life Sciences offer a free consultation meeting to help identify challenges in your clinical operations.

Contact us today and learn more about how the MedTech eClinical Suite from SMART-TRIAL and BSI Life Sciences can help you streamline your clinical operations.