Clinical Trial Management System (CTMS) is a cloud based, highly configurable, end-to-end, Clinical Trial Management System (CTMS) helps manage all aspects of clinical trials including:
- Site Monitoring Visits
- Milestones – Planning and Tracking
- Activities – Tasks & Deviations
- Payments – Site & Investigator
- Investigational Product (IP) Tracking & Inventory (IWRS)
- Patient Recruitment & Randomization (IWRS)
- Patient Visits – Scheduling and Tracking
- Site Selection, Site Initiation, Investigator Selection
- Master Data Management (Sites, Investigators)
- Regulatory documents & Compliance Tracking
- Study Budgets & Training Management
- Adverse event tracking and many more.
Salient Features of CTMS
- End-to-end Clinical Trial Management System (CTMS) system with integration to eTMF, EDC, QMS and Training Management Systems
- System provides alerts for regulatory documents, milestones, site and subject visits, tasks / action items, trainings
- Easily configurable workflows to meet the Sponsor SOPs and every requirement of clinical trials
- Master Data Management module to manage Sites, Investigators and study personnel master data with higher level of reusability of the information in different clinical trials.
- Consists of documents, activities, contacts, schedules, payments, milestones and more.
- Complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.
- Powerful and actionable dashboards and reports for real time monitoring and tracking of study and site status
E-TRIALS (eTMF/eISF/rSDV)
- eTMF is an extendable (as eISF & RMS) electronic trial master file in electronic format for organizing and storing documents, images, and other digital content of clinical trials.
- Electronic Investigator Site File (eISF) is a platform for investigator sites involved in the clinical trial for full control over their investigator site files (ISF).
- Remote Monitoring Systems (RMS) enables companies to perform remote Source Data Verification (rSDV) / remote Source Data Review (rSDR) without having monitors travelling to the sites.
- Electronic Trial Master File (eTMF)/ electronic Investigator Site File (eISF) has inbuilt DIA reference model and meets regulatory guidelines including:
- Digital content archiving,
- Security and access control,
- Change controls,
- Audit trails, and
- System validation
Salient Features of eTrials
- Inbuilt DIA eTMF organization structure and configurable organization structure for any Organization needs
- File /Study Plan along with milestones at the study level, country level, and site level.
- Live Tracking of documents at different stages like completed, QC, pending, review missing documents etc.
- Robust document lifecycle with Author, Review, eSign/Approval workflow & Automated version controlling with robust Check-in and Check-out functionality
- Advanced analytics to track Completeness, Quality, Timeliness and TMF compliance of a study.
- Bulk / Quick upload with Dynamic Indexing options for documents
- Allows a user to invite external parties to upload and work collaboratively on documents system in a controlled method
- System complies with DIA, 21 CFR Part 11, ANNEX 11, GxP and GDPR guidelines.
- Can be used as a focused eTMF or as a general document management system for the clinical trials.
- Pre-built eISF reference model & also allows sites to define their own / Study / Site specific ISF structure
- Audit trail maintained for every operation
- RMS Tracks the remote Source Data Verification (rSDV) status at every level of a clinical trial
- Allows to create File Plan , milestones and placeholders at the Study / Site / Patient / Visit level for remote Source Data Verification (rSDV)
- RMS System provides options to redact sensitive information from the site / patient / visit documents.
ELECTRONIC DATA CAPTURE (EDC)/eCRF
- Manage all clinical data management aspects including Study Planning, Study build, Study Conduct, Discrepancy / Queries management, Medical Coding, Data Extract, etc.
- Integrated with Quality Management System (QMS) to manage CAPA, Change, Deviations, Audits, Compliance documents, Training etc of a Clinical Trial.
- Inbuilt medical coding feature to setup MedDRA and WHODD dictionaries and code the clinical data using these dictionaries seamlessly
- Complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.
- Powerful and actionable dashboards and reports for real time monitoring and tracking of study and site data and discrepancy / queries
- Inbuilt Metadata Repository (MDR) and Master data management (MDM) to manage Study Global libraries, Sites, Investigators, Products and other master data in a centralized repository and provides a higher level of reusability of the information in different clinical trials.
QUALITY MANAGEMENT SYSTEM
- QMS manages quality and compliance processes digitally by enabling organizations to manage documents, training, Change, CAPA, Deviation, audits in one place.
- Easily configurable workflows to meet any complex organization requirements for managing CAPA, CR, Deviations and Audits.
- Inbuilt Training Management System to efficiently manage organization’s training processes.
- Inbuilt Document Management System to efficiently manage organization’s SOPs, Documents, Work instructions, etc.
- Complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.
- Powerful and actionable dashboards and reports for real time monitoring and tracking of quality and compliance.
Training Management System
- TMS helps Organizations to Create, Assign, Assess, Track, Monitor and Report, Trainings seamlessly.
- Trainer can create trainings and upload the training documents / videos / files
- Trainer can assign the questions (evaluation) and answers and the passing score for the training
- Trainer can assign the created trainings to set of participants or to certain user groups / users
- System shall have the capabilities to send reminders for the pending trainings
- Dashboards and reports – organization level and project level training completion and compliance
- Audit reports for training records – At individual trainee level, or at some specific training level, etc.
- CTMS Integration – Trainings scheduled , tracked and managed in CTMS will be available for training