EDC/ePRO System Implementation

CAC Croit helps with the implementation of electronic data capture (EDC) and electronic patient-reported outcome (ePRO) systems, as well as providing solutions for effective usage. We can also provide support with communication and document preparation in English during global studies.

 

Are you facing any of these issues?

  • You need to increase the efficiency of EDC system set up before going live.
  • You need to streamline EDC preparation and usage.
  • You need to accommodate substantial changes in your schedule.

Croit’s solutions:

  • We provide simplified procedures for efficient system setup which work in accordance with your plans.
    *We finished an EDC system within a month of the request.
  • Our technical team supports preparation and usage of the EDC system.
  • We can partner with you in a number of flexible ways. A multi study partnership is the best way to guarantee access to sufficient staff during transitional phases.

Service flow

01: EDC/ePRO implementation consultation,02: EDC/ePRO preparation,03: EDC/ePRO usage,04: Data provisioning and trial close-out procedures

 

EDC/ePRO implementation consultation

  • We propose and create customized workflows which mesh with your operations.
  • We ensure smooth end-to-end clinical study operations for drug applications, standardizing eCRFs and complying with CDISC standards from the early stages.
  • We help you clarify operational roles and responsibilities for seamless coordination between departments.

Example of consultation process:

Example of consultation process

Optional services

  • SOP creation support
  • eCRF standardization for drug applications

EDC system preparation

  • Quick and high-quality EDC system preparation built on the knowledge gained from our previous service offerings
  • Logical checks and custom forms available

EDC system preparation

Optional services

  • Compliance with CDISC taking applications into account
  • Linking with external systems (including a progress management system and an IWRS)
  • Creation of SAS logical check programs for logical checks outside of the EDC system
  • Support for computerized system validation (CSV)
  • Creation of EDC operating manual and CRF instructions

EDC system use

  • We ensure smooth operation using the EDC system. Our personnel handle communication with the EDC vendor.

Optional services

  • Creation of data management (DM) support tools
  • Data visualization and analysis with Spotfire®
  • Support for centralized monitoring of risk-based monitoring (RBM)
  • Support, checking, and processing of external EDC data capture
  • Training for site users, your DM team, monitors, and other personnel
  • Help desk
  • Technical support for EDC

Data provision and trial close-out procedures

  • Trial close-out procedures designed to ensure you meet requirements and industry best practices. (PDF format)
  • Prompt delivery of datasets for analysis

Optional services

  • Creation of storage media for sites and sponsors

ePRO system setup and operation

PROs have been receiving considerable attention as patient-centricity has increasingly become the focus in drug development.
Croit will provide the following ePRO solutions with optional services based on your requirements and our experience in data management and IT/CSV support:

 

  • Full support from preparation of ePRO questionnaires through to system vendor management.
  • Proposals of a suitable CSV plan. We also provide support and advice for clients new to ePRO products.

Optional services

  • Support for obtaining authorization to use questionnaires
  • Procurement, management, and retrieval of devices for ePRO entry
  • Training for site users, monitors, and personnel in charge of the questionnaires
  • Helpdesk

Multi-study contracts

Croit has worked with both individual and multi-study contracts.

Benefits

  • Swift and flexible changes in design to reflect protocol revisions
  • Reduce man-hours by standardizing logical checks and tools
  • Automate operations with RPA and other tools
  • Customized services by combining optional EDC services with consultations to increase efficiency of EDC system preparation and implementation.
  • Flexible with significant schedule changes
  • By taking into account EDC trial design from the drafting stage, the period from fixing protocol to going live can be shortened.

EDC/CDMS/ePRO systems

Experience:

 

  • Rave EDC/Classic Rave
    • 140 studies since 2010
  • Rave Coder
  • Edge Targeted SDV
  • DATATRAK ONE™
  • Viedoc™/ViedocMe

* Other EDC, ePRO, eCOA (electronic clinical outcome assessment) systems are also available. Please contact us for details.

Benefits

  • Short implementation time and streamlined procedures according to workflow.
  • Standardize the first study to shorten the time required to set up the EDC for subsequent studies.
  • We handle inquiries from sites, monitors, and MRs to reduce your workload.

Experiences

Therapeutic category of drugs

Clinical trials
  • Agents affecting nervous system and sensory organs
  • Agents affecting metabolism
  • Agents affecting cellular function
  • Agents affecting central nervous system
  • Agents affecting sensory organs
  • Agents affecting cardiovascular function
  • Agents affecting respiratory organs
  • Agents affecting digestive organs
  • Hormone preparations (including anti-hormone preparations)
  • Agents for urogenital and anal organs
  • Agents for epidermis
  • Agents relating to blood and body fluids
  • Antineoplastic agents
  • Antiallergic agents
  • Antibiotic preparations
  • Biological preparations
Postmarketing
  • Agents affecting central nervous system
  • Agents affecting sensory organs
  • Agents affecting cardiovascular function
  • Agents affecting respiratory organs
  • Agents for urogenital and anal organs
  • Agents for epidermis
  • Agents relating to blood and body fluids
  • Agents for artificial dialysis
  • Agents affecting metabolism
  • Antineoplastic agents
  • Antibiotic preparations
  • Biological preparations
  • Agents against parasites
  • Agents against pathogenic organisms and parasites
  • Hormone preparations (including ant-ihormone preparations)

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