RWE CLINICAL STUDY

As more and more anonymous real-world data sources become available, the capacity to ingest, standardize, and then connect the heterogeneous datasets collected is critical to creating insightful analytical results.

A COMPREHENSIVE OFFER

Our RWE solutions cover your needs from creating the Clinical Evaluation Report to identifying and executing the right RWE study for your post-market clinical follow-up.

REQUEST FOR QUOTE

Plan your RWE clinical studies with Eclevar and benefit from our network and expertise in data strategy.

Hospital

EVOLVING REGULATORY PROCESSES

New evidence requirements for medical devices are being implemented from May 2021, particularly in the EU. The introduction of the MDR significantly increases the level of regulatory requirements when collecting clinical data and generating medical evidence.

Producing more robust and clinically meaningful medical evidence requires access to richer data sources along with an expertise and understanding of real-world data.

OUR ADDED-VALUE

Controlled trials are a key factor in demonstrating the effectiveness of a new medical device at the experimental stage, with current approval processes reaching more and more their limits.
The consideration of RWE in regulatory decisions is growing beyond post-approval requirements.

Eclevar builds a scalable infrastructure and benefits from dynamic, long-term relationships with hospitals. This approach enables the creation of curated portfolios of high quality data in different geographical and therapeutic areas, tailored to your medical device.

Partnership with a network of hospitals

20+M non-identified patient records​​

6-8 months for Real World Trials​​

3 weeks for data extraction​​

"Controlled trials will continue to form the evidence backbone for regulatory decisions; however, RWE has the potential and is destined to play a more widespread role in medical device approval processes.”
Chems Hachani
CHEMS HACHANI
CEO, Eclevar

A STRUCTURED ECOSYSTEM