Open Source EDC

Clinovo EDC SoluMons  Regulatory  requirements  have  significantly  lengthened  and  complicated  clinical  trials,  resulMng  in  an  11%  annual  rise  in  clinical  tesMng expenses and delays in FDA submission.   As  a  result,  sponsors  are  looking  for  efficient  technology  soluMons,  such as EDC, to avoid human error during data collecMon and assess  clinical data quality at an earlier stage.  ImplemenMng  a  new  EDC  system  requires  in‐house  technology  experMse  that  can  prove  Mme‐consuming  and  expensive  to  acquire.  Your local Clinovo‐team will guide you through the enMre set‐up and  implementaMon process to help you significantly reduce your Mme to  market.

OUR EDC EXPERTISE    Experienced with all major EDC plaWorms

 21 CFR Part 11 compliance

  Expert in FDA standards and guidelines

 Helpdesk system for any EDC plaWorm

  Best‐of‐breed technology and unique domain experMse

 InnovaMve clinical systems developed in‐house

Clinovo  believes  in  innovaMon.  As  such,  we  have  been  a  strong  proponent  of  open  source  technologies.  To  help  sponsors  conduct  faster,  cost‐effecMve  clinical  trials,  we  offer  ClinCapture,  a  proven  web‐based  open  source  EDC  system.  Fully  customizable  to  your  study,  ClinCapture  delivers  the  same  benefits  as  proprietary  soluMons, but without the license fees.

HIGHER FUNCTIONALITY AT LOWER COSTS

OUR ENHANCEMENTS TO #1 OPEN SOURCE EDC

    No license fee

   Full system validaMon

    Based on #1 open source EDC plaWorm:

   IntuiMve plaWorm navigaMon

over 11,000 developers and users worldwide

   CustomizaMon to match your protocol

    User‐friendly and conﬁgurable web‐based interface

   Complex edit checks

    Vendor independent

   Password and account security

    Seamless access to your clinical data

   CRF design & layout

ABOUT CLINOVO Clinovo  is  your  leading  edge  Clinical  Data  SoluMons  Provider.  We  provide  local  medical  device,  biotechnology  and  pharmaceuMcal  companies  with  full  service  biometrics,  such  as  Clinical  Data  Management,  Electronic  Data  Capture,  BiostaMsMcs,  and  CDISC  mapping.  By  leveraging  best‐of‐breed  technology,  we  develop  and  customize  turn key soluMons 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  +1 800 987 6007

San Diego Oﬃce  +1 760 579 7352

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