Clinical trials constitute the single most expensive component of the entire drug development process. In particular, clinical trial operations represent one of the most resource-intensive areas within a biopharmaceutical company and often involve tedious, manual processes for collecting, aggregating and rationalizing information from a wide variety of data sources.
Pharmaceutical, Biotech and Contract Research Organizations (CRO) that implement integrated, electronic systems to manage their clinical trial processes gain the advantage of real-time tracking, effective control, and proven, repeatable processes. As a result, leading companies are implementing Clinical Trial Management Systems (CTMS) to improve the tracking and oversight of clinical trials processes. Visual Sparks Technologies in conjunction with industry leaders has developed a vtrial – Clinical Trial Management System (CTMS) that improves efficiency, integrity and quality across all levels of clinical trials.
vtrial – Clinical Trial Management System (CTMS):
vtrial automates and streamlines workflow processes and increases the visibility of related tasks and data in a clinical study.
vtrial provides organizations with a fully SaaS based solution that tracks, manages, and controls all clinical trials processes and tasks through a consolidated dashboard view. As a result, all shareholders, including sponsors, senior management, trial managers, finance, clinical operations and regulatory affairs, have complete visibility into the current status of all trials, and related actions that are critical to the success of the program.
In addition to reducing costs and accelerating time to market, vtrial improves compliance with clinical trial protocols, supports FDA’s compliences such as, HIPAA, Title 21 CFR Part 11 and Good Clinical Practices (GCP), and ensures deviations and problems are tracked and responded to.
- Web based system for unrivalled accessibility
- Study and protocol tracking
- Site status tracking
- Patient/CRF tracking, entry, and verification
- Site initiation visits, close-out visits, audits, and other visits
- Flexible data entry options
- Digital pen and paper technology enabled
- Double Data Entry
- Automated double data entry comparison and synchoronization
- Electronic and manual discrepancy identification and automated data queries (ADQ) generation
- Paper and electronic CRF and document management
- Protocol reviews
- Change control tracking
- Serious Adverse Event (SAE) collection, processing, reconciliation and reporting
- Robust query management capabilities
- Automated edit checks and validation for compliances
- Integrated medical coding references (MedDRA, WHO-Drug, WHOART, COSTART or Sponsor-developed)
- Customized Reporting for Sponsors, Project Manager, Investigators, Medical Monitors, CRA’s
- Compliance with HIPAA privacy and security guidelines including Title 21 CFR Part 11 and use of study-specific user roles and privileges, SSL encryption, de-identification of Protected Health Information (PHI), and auditing to monitor access and changes by users.
- Data import/export tools for migration of clinical datasets in SAS, SPSS, CSV, Excel spreadsheets, local databases and legacy data formats
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