Clinovo EDC SoluOons Regulatory requirements have significantly lengthened and complicated clinical trials, resulOng in an 11% annual rise in clinical tesOng expenses and delays in FDA submission. As a result, sponsors are looking for efficient technology soluOons, such as EDC, to avoid human error during data collecOon and assess clinical data quality at an earlier stage. ImplemenOng a new EDC system requires in‐house technology experOse that can prove Ome consuming and expensive to acquire. Your local Clinovo team will guide you through the enOre set‐up and implementaOon process to help you significantly reduce your Ome to market.
OUR EDC EXPERTISE Best of breed technology and industry experOse
21 CFR Part 11 validaOon
Local dedicated team of experts
Excellent data accuracy and integrity
Expert in FDA standards and guidelines
Customized plaZorm design
MEDIDATA RAVE SERVICES When so much is at stake, you can only rely on a proven soluOon. Clinovo supports the EDC industry leader: Medidata Rave. Clinovo is able to tailor the Rave EDC plaZorm through custom funcOons to meet your specific protocol requirements and achieve faster study build.
AN EXPERIENCED TEAM
FULL CUSTOMIZATION
Medidata Rave cerOfied study builders
Global library set‐up
Agile implementaOon
Custom funcOons development
Back end integraOon
ConfiguraOon of user‐interface and workflow
Study migraOon
eCRF design and customizaOon
Industry standard based architecture
User‐controlled access to eCRFs/data entry
User acceptance tesOng
Complex edit checks configuraOon and verificaOon
ABOUT CLINOVO Clinovo is your leading edge Clinical Data SoluOons Provider. We provide local medical device, biotechnology and pharmaceuOcal companies with full service biometrics, such as Clinical Data Management, Electronic Data Capture, BiostaOsOcs, and CDISC mapping. By leveraging best‐of‐breed technology, we develop and customize turn key soluOons that accelerate the clinical trial process and speed up regulatory review.
Visit our website: www.clinovo.com Contact us today to accelerate your clinical trial: sales@clinovo.com Sunnyvale Office, CA +1 408 773 6254
San Diego Office, CA +1 760 579 7352