Clinical Trial Management System(CTMS)

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

  1. Manage all clinical data management aspects including Study Planning, Study build, Study Conduct, Discrepancy / Queries management, Medical Coding, Data Extract, etc.
  2. Integrated with Quality Management System (QMS) to manage CAPA, Change, Deviations, Audits, Compliance documents, Training etc of a Clinical Trial.
  3. Inbuilt medical coding feature to setup MedDRA and WHODD dictionaries and code the clinical data using these dictionaries seamlessly
  4. Complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR.
  5. Powerful and actionable dashboards and reports for real time monitoring and tracking of study and site data and discrepancy / queries
  6. 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













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