Case Study: MCRA Assists Evaheart’s Pivotal COMPETENCE Trial in Support of the EVAHEART®2 LVAS

Components

Client Need

Evaheart approached MCRA to provide ad hoc clinical consulting and monitoring services to serve as an extension of the Evaheart team. Through the initial scope of work, Evaheart invited MCRA to provide a more full-service approach to the pivotal study, including data management, CEC and DSMB administrative support. 

A 3D image of an anatomical red heart with a pink-purple background.

MCRA provided full-service support for Evaheart's pivotal study including data management, CEC and DSMB administrative support.

MCRA Approach

MCRA’s integrated teams across clinical affairs, data management, site management, monitoring, and safety committee management collaborate closely together to manage the clinical study.    

 

MCRA THERAPY: Cardiovascular

 

MCRA SERVICES: Global CRO Services, including Ad hoc Monitoring, Clinical Management, Data Management, Safety Meeting Committee -DSMB and CEC 

Outcome

MCRA successfully joined the Evaheart clinical team to conduct interim monitoring visits, ongoing data management /data cleaning activities, and conduct safety meetings efficiently.  

 

 

Our team initially contracted with MCRA for consulting work then went on to contract with MCRA as a CRO. MCRA consultants are knowledgeable, reliable and consistent. The team has been a pleasure to work with and has really guided our team to become more structured and confident.

Lizatte Martinez
Clinical Trial Lead, Evaheart

Meet Our Team

View Contact
Lisa Beck, BSN, M.S.

Lisa Beck, BSN, M.S.

Senior Director, Clinical Affairs