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Leverage a Robust EDC Solution for Phase I to IV Clinical Trials Data Management and Medical Coding

‘AccelClinical’ is a fully-managed, cloud-based integrated clinical data management solution offered by Techsol using Oracle Clinical, Oracle Remote Data Capture (RDC) and Oracle Thesaurus Management System (TMS) applications.

Using AccelClinical, emerging biopharma companies, device manufacturers, and service providers can easily manage Case Report Form (CRF) design, study data collection, discrepancy management, medical coding and study data reporting across Phase 1 to Phase IV clinical trials. Our unified solution allows customers to conduct both paper-based and electronic data capture (EDC) clinical trials seamlessly with built-in edit checks for facilitating faster data cleansing and generating high quality data sets for statistical analysis.

Key Solution Capabilities

Following are the feature functionalities available with AccelClinical for both paper-based and EDC clinical studies:

Fast and Flexible Study Design

For Early phase to Late-phase Clinical Trials

  • Facilitates rapid study design with reusable study objects
  • Supports complex trial design multiple treatment arms with different assessment schedules, multiple randomization points, and repeating treatment cycles
  • Allows the customization of electronic Case Report Forms (eCRF)
  • Auto-generates CRF annotation for study documentation

Robust Discrepancy and Query Management

To Optimize Clinical Trials Data Quality

  • Has programmable edit checks to generate both online and offline queries
  • Intuitive CRF icons with distinct color status codes facilitate easy study data review and discrepancy management
  • Paper based clinical studies can leverage Data Clarification Forms (DCF) for discrepancy management
  • Has comprehensive metrics and reports to track study data capture, query resolution, data quality, etc.

Risk-based Source Data Verification

Across different Treatment Arms

  • Allows the creation of a risk-based source data verification (SDV) plan
  • Automated patient selection occurs when SDV plan is published
  • Allows setup of Critical Case Report Forms which require 100% SDV verification
  • Track outcomes of SDV with built-in reports

Comprehensive Study Data Management and Medical Coding

Supports faster database lock

  • Track all clinical study data statuses with robust querying and reporting
  • Perform automated medical coding of Adverse Events, Medical History and Concomitant Medication terms using MedDRA and WHO Drug dictionaries
  • Close all data discrepancies with built-in quality review cycle as per process SOPs
  • Has flexible options to perform database lock, freeze and unlock

How is the ‘AccelClinical’ solution delivered?

AccelClinical is delivered on a GxP compliant fully-managed cloud platform where all ongoing systems validation and preventive maintenance of Oracle Clinical, RDC, TMS and associated add-on applications will be managed by Techsol throughout the business lifecycle. As an Oracle Gold Partner, we have the required resources to complete timely application upgrades and patch deployments.

Rapid Cloud Onboarding Model

  • Fast track implementation with phased approach for global roll-outs
  • Continuance guidance from SMEs for business process design
  • Business-user training (Train the trainer, Classroom, Remote)

Solution Validation Readiness

  • AccelClinical is UAT ready for clients
  • Offered with 4 system environments (DEV, VAL, PROD and DR)
  • Solution is certified for regulatory compliance (21 CFR Part 11, EU Annex 11)
  • Continuous support from SMEs for PQ/UAT execution

Service Desk and Disaster Recovery

  • 24×7 Oracle Clinical, RDC and Oracle TMS support (Requests, Incidents, Change)
  • Preventive Maintenance & Cloud Monitoring
  • Technical support for ongoing configurations management
  • Functional support for troubleshooting business workflows
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