Compier Clinical Adjudication

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Clinical Adjudication

Solution Overview

  • Centralized adjudication portal that automates and streamlines following processes:
    • Adjudication methodology set-up
    • Data collection from sites
    • Online adjudication process (including reconciliations)
    • Integrated Ad-hoc reports and publishing
  • Interfaces directly with various EDC systems using web services as well as programmed SAS input.
  • A secure electronic platform that ensures 21 CFR Part 11 compliance.
  • Integrated access to imaging applications.
  • Offered as Software as a Service (hosted) along with set-up services and 24X7 – 365 days help desk support.

Features:

  • On-line Data Collection From Sites
  • Centralized Adjudication Workflow
  • Tracking and Management
  • Interactive Dashboards and Reports

Key Advantages

  • Bringing efficiency in costing by eliminating traveling of CEC members.
  • Allows onboarding of international review committees using best physicians per therapeutic area.
  • Flexible design allows for use in any event type.
  • Collection of data from different organizations, if needed.
  • Cutting down the cycle time for adjudication committee to perform assessments.
  • Improves data quality through use of eCRFs and online edit checks.
  • Can accommodate any number of users and adjudicators.
  • User privileges can be assigned based on specific and customizable roles.

Techsol Adjudication Services Capabilities

  • Identification of chair and members for adjudication committee
  • Contract with and management of members
  • Preparation of the Charter of Operations document
    • Events to be adjudicated/identification/alert
    • Source documents to support event
    • Review process
    • Adjudication questions
  • Preparing Operational Procedures and Data Entry Guidelines
  • Preparing and distributing event dossiers/profiles with Compier Clinical Adjudication Sloution
    • AS – Translation, review for subject de-identification
    • Manage review rounds, final results
  • Project management / report events status
  • Meeting management: Orientation and Consensus
  • Build/Configure the Virtual Clinical Adjudication System – Data transfer and end-of-study file transfer

How Techsol Adjudication Services Simplify Your Clinical Trials

  • A single solution for end-to-end adjudication package that combines in-depth expertise across all critical areas:
    • Medical
    • Clinical
    • Regulatory
  • Our services are integrated with Clinical Services, allowing our assessment professionals to address patient event issues quickly and directly, with more efficient regulatory compliance and proactive client reports.
  • Delivering services with flexibility to customizable for trials by size, scope, event types, patient, eligibility, therapeutic area, duration, budget, and geographic specificity.
  • Compier Clinical Adjudication Solution is a secure cloud program that operates in a hosted environment, can accommodate any number of users and events, and can be accessed by adjudicators wherever they are, worldwide.
  • Clinical Committee members can participate from anywhere – worldwide. This reduces time delays and costs, with no compromise in quality of reviews or analysis.

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