Leverage a Robust EDC Solution for Phase I to IV Clinical Trials Data Management and Medical Coding
Techsol specializes in providing integrated GxP compliant, ready-to-use software platforms for sponsors to streamline data collection, stakeholder collaboration, oversee business processes and gain insights across the clinical development lifecycle.
‘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.
Key Solution Capabilities
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. Following are the feature functionalities available with AccelClinical for both paper-based and EDC clinical studies:
> 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
> 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
> 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.
> 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
‘AccelStudy’ is delivered on a GxP compliant fully-managed cloud platform hosted on Amazon Web Services (AWS) which has security and quality certifications such as ISO 9001, ISO 27001, ISO 27017 and ISO 27018.
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 Partner, we have the required resources to complete timely application upgrades and patch deployments.
AccelClinical is UAT ready for clients. It is offered with 4 system environments (DEV, VAL, PROD and DR). The Solution is certified for regulatory compliance (21 CFR Part 11, EU Annex 11). Business users will receieve continuous support from our SMEs for PQ/UAT execution.
Our 24×7 Service Desk is always available
- 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