Overview of AccelClinical

‘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.

What are the unique solution features available within AccelClinical?

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

Fast & Flexible Study Design
  • 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
Risk-based Source Data Verification
  • 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
Robust Discrepancy Management
  • 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
Study Data Management & Medical Coding
  • 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
Study Data Reporting
  • Oracle Clinical automatically create views corresponding to each CRF and extract data into SAS for analysis
  • Allows creation of custom views combining data from multiple CRFs
  • Facilitates creation of various data snapshots for interim analysis during normal data processing

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.

  • 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)
  • AccelClinical is pre-validated with IQ/OQ and is UAT ready
  • 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
  • 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

Business Benefits

  • Provides a single application and infrastructure for EDC and CDM
  • Supports flexible modeling studies with complex trial design scenarios
  • Defines multiple potential pathways a patient might take through a study
  • Enforces standards and consistency with global library
  • Delivers full integration with Oracle Remote Data Capture