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Oasis-CTMS, Clinical Trials Management System

Oasis CTMS is specifically designed to manage the entire cycle of clinical trials processes and studies, bio-analysis starting from schedules, registration of sample to the final results, it automates the complete process workflow of laboratory with regulatory compliance…

  • • Protocols/study designs and Projects Management
  • • Lab process across all sites
  • • Increase efficiency by automating data handling and reporting task
  • • Compliance throughout the process for data integrity
  • • Track study, sample history from receipt to disposition, summaries

Master Database – Volunteer’s/Subjects
Provision to maintain subjects/volunteer’s demographic and physical parameter data such as name, age / sex, address, phone etc. Provision for reports on subject’s demographics, consents, clinical notes and testing results Entry of doctor / consultant / customer master with name, address, phone etc
Test Management
• Type of tests

• Test library for laboratory tests

• Test profiles

• Test Details - Test Limits / formats

Study Design and Protocols
Model flexible study designs and protocols, apply amend protocols during study with integrated change management module of Oasis-QMS … integrated electronic signatures at all levels
Define key elements of research / trail protocols
Comprehensive projects management module with study timelines / TCD’s Study types, blinded / un-blinded with encoding / decoding Track down study progress through project management graphical interface Gantt charts Study lock, close-out and archival
Protocol and Study management
Provision for study protocols logins with the facility of amendment with revisions history Protocols amendments to be handled by integrated change management module of QMS Integrated electronic signatures at all levels of protocol approvals Study Tracking with projects management Study report tracking with graphical interface Study lock, close-out and archrivals
Regulatory Submissions
Design various user defined forms as pre-requisites for clinical/non clinical studies and trials such as …
  • • Contracts
  • • Negotiations
  • • Volunteer's / subject consent forms …
  • • Demographic data, physical parameters etc.
  • • CRA appointments
  • • Subject allocation
  • • IRB and Ethical submissions
  • • Registrations
Regulatory Submissions and compliance
Upload and maintain various Forms / Formats such as Customer Contracts Negotiations CRA appointments Subject allocation IRB and Ethical submissions Registrations Controlled system access to authorized users, role bases access to ensure authorized actions can be performed by users in accordance with GLP. Provision for audit trails of all events performed in system, create, change and delete Electronic Signatures with user identity and password, time/date stamp and reason for change / delete as required by 21 CFR Part 11 International Regulatory Compliance (US FDA/ GCP)
LIMS and Bio-Analytical Module
Path lab software design to support BE/clinical trials Provision for entering schedules for sample collection Sample receipts with barcodes to identify and track samples on labels; software driven barcode label printing Provision for sample logins with on-line selection of tests to be performed on sample Provision for work allocation of sample tests and Generation of worksheets, department wise – bio-chemistry, haematology, microbiology Provision for test-wise results entry Generation of ‘Final Test Reports’ and other sample reports, test reports approvals with electronic signatures, QA reviews and re-assay management Provision for handling of adverse events / serious Adverse Reactions to be integrated with QMS for investigation and further action with CAPA Reports and Data Transfers
Test definitions / Sample Receipts and Management
Management of tests and limits, group tests / profiles Create fixed and flexible schedules for sample collection, sample receipts (create new or imports existing barcodes to identify and track samples. Provision for samples dispatch to central clinical / Bio-Analytical Lab with Transportation / logistics details … and receipts confirmations at Central Clinical / Bio-Analytical Lab followed by registration / login’s of samples with test/profiles allocations. Define sample locations, track down to shelf positions
Reading / Observations – Results Entry
Work allocations and worksheets, department wise – bio-chemistry, hematology, microbiology to conduct and analyze a wide range of routine and customize test with the provision to enter raw data, observations/readings and results in electronic form etc. Data Acquisitions, OasisLIMS / O-Link module integrates with various instruments having data acquisition interface to capture data directly which helps preserve data integrity. Provision for samples dispatch to central clinical / Bio-Analytical Lab with Transportation / logistics details Generation of Final Test Reports and other sample reports Adverse Events / Serious Adverse Reactions
QA Reviews and Re-assay management
Test reports review and approvals with electronic signatures Review the history and attributable changes in Audit Trails pertaining to execution of sample life-cycle. Identify re-assays and decision on sample repeats
Reports and Data Transfers
Customize data export to client requirements and report in industry standard formats, secure the reports under document management system.

Some reports at a glance …

Master data … Protocols, Study Reports, Project, Gantt Charts, CRF, case report form, SOPs / STPs, Volunteer's/ Subject Data, all pre-requisites forms - RA, Schedules, Sample registers, Barcode Labels, Work sheets, Test Reports / Certificate of analysis, Pending Schedules, Samples pending for registration, Samples under analysis, Samples pending for analysis, Test Reports pending for reviews, Sample status – track from receipt to disposition, Re-assay – repeat samples, Deviations - Adverse Reactions, Lab performance data, ... automatically flashed and directed to concerned users by issuing alerts and reminders in the logon screen home window User Administration Multiple – lab / satellite lab setup User Profiles User role / rights Report Approvals / authorizations etc.
…multi Labs / sites access, client access across the globe
... Ideal solution for Clinical Trials having wide range of clinical services and networked with hospitals connected to central clinical / bio-analytical lab. Using centrally deployed Oasis-CTMS, helps coordinate studies in a timely and efficient manner by making data available enterprise wide.

Regulatory and Other functional Requirements

Compliance throughout the entire process
Built-in DMS, assists users to comply with SOP’s, reduce risk of non-compliance Automatic pre-configured workflow allows users to follow standard workflow, without any deviations System access controlled, access granted to authorized users, role bases access ensures authorized actions can be performed by users in accordance with GLP. Audit Trails are stored in database, readily retrievable for review for all events performed in system, create, change and delete. Electronic Signatures record user identity, time/date stamp and reason for change / delete as required by 21 CFR Part 11.
Oasis LIMS provides highest level of system and data integrity, enabling fool proof security systems in place and also controlled system access. System Administrator has complete control in defining users, user roles and access privileges to use specific functionality of the system and right to authorize actions of other users. There is provision to implement electronic signatures with time stamps and unique user IDs and passwords are allocated to individuals
Audit Trails
LIMS includes one of the most comprehensive computer generated date and time-stamped audit trail and trace logs. This enables systems to maintain audit logs for all operators entries, to check who did what and when and why and where. All changes are recorded instantaneously and subsequently stored for future use during auditing and inspections, or QA reviews

Integrated Oasis CTMS Modules (Optional)

Integrated Document Management System
Define folders/sub folders to efficiently manage documents / raw data Prepare, edit and maintain STP’ and SOP’s, create/ apply amendment with full revision control and review dates Quickly built study report , incorporate documents, tables and graphs with full word processing capabilities with the facility to import or attach existing documents/files in a flexible manner. All reports and data is held in database which is controlled securely by user access and system roles.
Oasis-QMS – Integrated Quality Management Module …
a comprehensive web based tool that enables organization to effectively manage quality processes and record deviations pertaining to documents, STPs /SOPs / Procedures, protocols and other areas. • Change Control Management • Deviation Management • Incident Management (Lab / Environment) • Corrective and Preventive Actions
Add-on modules that empowers basic LIMS functions
LIMS has various add-on modules to work in conjunction with main LIMS activities, for better management and control of quality assurance operations • Trend Analysis • Equipment calibration management • Standards management • Samples retention management • Training records management

General Requirements

Reminders of overdue tasks and activities, pending for review, pending for approvals, due calibrations/AMC, due training, due sample collections etc
Data Integrity, Data security and access restrictions
Ensure subject data and sample privacy using multi level authentication for user-role based access control.
Audit Trail
Keep track of all user activities performed in your lab with a comprehensive audit trail.
Statutory guidelines
Work in a regulatory compliant environment by using electronic signatures and by maintaining audit trails. Follow 21 CFR Part 11 regulatory standards with ease.
Query Capabilities
Identify and locate specimens of interest for clinical research purposes with flexible and easy-to-use query templates through the system’s seamless graphic interface.
Easy configurable workflow to fits in unique environment and eliminate tedious manual entry
Back-up and Restore
Provision for system data backup with disaster recovery procedures