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EDC

EDC
Efficient and compliant eCRF software

Ennov EDC is a comprehensive clinical data management solution that allows clinical research personnel to easily define EDC studies and collect subject data without worrying about missing or inaccurate data.

Ennov EDC is easy to use and supports the design, deployment and capture of multi-center clinical trial data within a single flexible and scalable solution.  Our software supports clinical trials of any size, including large global trials, post-marketing trials, cohort trials, health surveillance, Phase I-IV trials and epidemiological trials.  Ennov EDC facilitates complete and accurate data collection and improves communication within clinical teams

Why Ennov is Better

Efficient and compliant eCRF software

Creating EDC studies is easy with Ennov EDC.  Our graphical design tools take the complexity out of creating eCRFs.   All standard field formats are supported and a wide array of validation rules and edit checks ensure that subject data are entered correctly the first time. Computed fields, calculated intervals and a configurable library of allowable values (harmonized with CDISC, CDASH and STDM standards) provide Ennov EDC with the flexibility required to support even the most sophisticated and complex study designs.

In addition, Ennov EDC working in tandem with EnnovePRO, patients can record their own diaries and quality of life assessments. Our intuitive EDC software significantly streamlines study design, consistency tests, medical coding (MedDRA, WHO Drug), data import and export.

Streamline randomization and trial supply management with Ennov RTSM software

Ennov Clinical embeds a system for a direct patient randomization within our eCRF software. Our IWRS (Interactive Web Response Service) provides many options, such as controlling eligibility through consistency pre-tests, choosing strata and randomization methods (blocks, minimization), activating the ”Randomization Factor” and managing investigational product supply. Our software makes it easier to manage a double-blind study and prevents any anticipation of later allocations. With Ennov Randomization module, you can have a global view of the randomization among all patients (i.e., success or failure) or at the individual patient level (various randomization operations or drug allocations).

EnnovePRO

Directly capture electronic patient data without worry using Ennov's ePRO software

Self-reported patient data are an important part of measuring drug efficacy and assessing quality of life in clinical trial subjects. However, the use of paper-based assessments can be cumbersome and difficult to manage, especially in large, complex global clinical trials where patient compliance can pose a significant challenge. EnnovePRO software automates the capture of electronic patient data through the use of online questionnaires that patients can complete from the privacy of their own home. These questionnaires use the same easy-to-use form designer as Ennov EDC and make patient data available to investigators and trial sponsors immediately upon completion.

Core Capabilities

  • Quick and easy eCRFdesign
  • Support for all data field formats
  • Computed data fields and interval calculations
  • Defined data field groups
  • Dynamic data field activation
  • Support for optional eCRFpages
  • Configurable library of allowable values

Key Features

  • Streamlined clinical data capture
  • Requires no IT or programming skills
  • Increased data visibility and security
  • Medical coding for MedDRA and WHO Drug
  • CDISC, CDASH and SDTM compliant
  • Full web interface
  • 21 CFR Part 11 compliant
  • BioClever Barcelona
  • Rambla Catalunya, 135, 3º 1ª, 08008 Barcelona
  • 934086388
  • info@bioclever.com
  • BioClever Madrid
  • Ronda de Poniente, 10 28760 Tres Cantos - Madrid
  • 910888877
  • info@bioclever.com