The proven, flexible, and scalable Intranet/cloud-based solution that can help Pharmaceutical Companies, Life Sciences, CROs and other research organization in many ways:

Clinical Trial Management System is a complete digital solution that helps a Contract Research Organization (CRO), life sciences, Pharmaceutical and healthcare industries to plan, track and maintain all its activities related to their clinical operations and volunteer data in conducting Clinical Trials. This solution would definitely help users cut down the time in data recording by digitizing the processes, quick accessible reports shall help project investigators and project managers take decisions.

Provision of study setup at one place enables many other modules to prepare record fields as per the planned time points. A fully configurable eCTMS solution enables the easy management of clinical trial records in a digital form.

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Regulatory Compliant

Intranet/Cloud Application

Data Standard Capability

Secure

Volunteer Visit Record
Kiosk (Volunteer Entry-Exit)
Protocol Training
Barcode Management
Volunteer Database Management
Staff Management
Study Management
Check In
Subject Management
Sensitive Data Approval
Audit Trail
Check Out
Supply Management
Finance
External Interface
Data Transcribe
Monitoring
Activity Management
Reports
Sample Processing
Study Activities
MEdical Screening
Project Management
CDISC (SDTM & ADaM)

Core Features

Clinical Operations

  • Real time available reports for quick decisions
  • End-to-end transparency
  • Inspection ready data availability
  • Higher compliance
  • Enables multiple users to access data for their specific roles
  • Role rights based access to users
  • Provides sponsors, CROs, and sites access to recorded data via a view-only study portal

IT

  • Easy to configure
  • Comprehensive auditable data
  • Faster deployment with simple setup and implementation
  • Easy to maintain
  • Easy device integration
  • Complete system validation with reports

Data Management

  • Centralized administration based on role based access
  • Single platform to capture, manage and access with custom listing and groupings
  • Faster study set up and operations
  • Dynamic report is also possible, enabling the users to create their own print ready reports with custom logics

Real time Authentication

  • Faster Fingerprint verification of volunteers
  • Data recording and updates authentication via fingerprint, credentials and barcode
  • Approval level to allow any modification in record through sensitive data handling
  • Mode of authentication by username-password, barcode and fingerprint for data entry and updates

About Us

Cloudester Software, is helping businesses that includes industries from life sciences, CROs, healthcare, clinical etc., so that they can harness the power of the internet and digital technology at the fullest and fulfil their every IT requirement which can vitally help them in migrating and automating their existing workflow and even make it more efficient with digital solutions. We create such type of products which help businesses to take their existing systems to a whole new level and effectively reduce costs and increase productivity. We firmly believe that every process can be carried out in a way more better way than it is usually carried out and we work in that prospect to make sure that our clients stay ahead of the competition and inside the wall of next generation business community. So let’s join our hands, design the future together and make it a reality.

At Cloudester we are highly concerned about the client’s confidential data and we consider it to be our utmost duty to keep it safe and isolated. We are always ready to sign a Non-Disclosure agreement to make sure that the client’s data is safe and secured with us. We also offer annual maintenance services for our products which are basically charged with respect to the services chosen by the clients. Annual Maintenance Cost i.e. AMC is negotiable and optional but we highly recommend you to give it a go if you wish to have the betterment of your business.

Our Support

Software Validation

Support & Services

Gap Analysis

Digitizing Clinical & Project Operations

Easy integration with key systems

Solutions

Electronic Clinical Trial Management System (e-CTMS)
  • Dashboard showcases the available modules to the user as per the rights and role matrix
  • Easy and fast access to various modules and sub modules
  • Easy department and division categorization of the activities to help user select required activity module and sub module

  • Addition of staffs into the system with roles and rights and user type privilege
  • Management of add, edit and view rights for modules and sub modules
  • Activation and deactivation of the staffs
  • Password management in terms of resetting the password at admin and user level

  • Provides a platform where subject registration can be done with demographic details and other details
  • Provision to capture complete biographic details
  • Identity & Address proof attachment provision
  • Fingerprints are captured for both the hands
  • Direct photograph capture into the system
  • Volunteer identification before registration
  • Volunteers are selected as per project criteria or generic screening processes can also be performed and selected in study on basis of Screening Eligibility Criteria

  • Availability of details for searched volunteer of past study participation, screening history, next eligible screening date etc.
  • Volunteers are selected as per project criteria or generic screening processes can also be performed to later select volunteers in study on basis of Screening Eligibility Criteria.
  • Allocation of projects based on the system check for, data verification, status declaration.
  • Allows allocate project to a screened and fit volunteer and based on the system check for, data verification, status declaration.

  • Screening of subjects and declaration of fitness status
  • Categorization of MSR into 3 parts, MSR1, MSR2 and MSR3
  • Medical Screening Record part 1 records the demographics and other general information.
  • Medical Screening Record part 2 is used to collect medical information of volunteers.
  • Medical Screening Record part 3 is used to take final decision on fitness and eligibility of the volunteer based on MSR2 and MSR1.
  • All details like general information, past history, general examination, systemic examination, clinical examination, for female subject different examination details are to be entered Verification of entered MSR details by another user
  • In conclusion for fitness status, is subject eligible or not should be entered by PI/Responsible User with Rights
  • Under screening history if user wants to edit the screening details, it can be done via sensitive data approval

  • Manage protocol specific trainings within the system
  • Manage other trainings like SOP and other process related trainings
  • Easy duty delegation to the trained users that allows users to work on project specific data recordings
  • System checks the project specific training records of users before allowing them to perform activities into the system
  • Generation of training reports for submissions

  • Generate Volunteer ID card with name and Volunteer ID
  • Generate subject ID card for the enrolled volunteer under study project with subject no.
  • Subject Id is generated for a Volunteer for the particular project with details as ID No, Initial, Age, Project No, Subject No, Signature box, Dosing Dates and barcode.

  • Perform examination based on the set checklist

  • Perform Urine drug test based on the selection of, By project details, By screening Date or By Volunteer ID
  • View history of the activities based on the filters

  • Perform Breath alcohol test based on the selection of, By project details, By screening Date or By Volunteer ID
  • View history of the activities based on the filters

  • Allows uploading of the hard records wherever required
  • Allows uploading of the identity proof
  • Upload relevant documents with no limits

  • Enter details for inclusion and exclusion as set under study project
  • This module describes all the inclusion and exclusion criteria of the project for a volunteer.
  • The volunteer should fulfil the listed, inclusion criteria to be considered for inclusion into the study. The volunteer will be excluded based on the listed exclusion criteria

  • Enrollment of the subjects into the project by assigning a unique subject ID
  • Authentication by the user enrolling subject into the project

  • Physician can access details to assess the data and clinical signs for the subjects
  • Details that physician can access are (Inclusion/Exclusion criteria, Clinical examination, Adverse Event, Treatment sheet, ECG evaluation, Sample evaluation and CRF verification)

  • Subjects are identified by fingerprint or barcode on the basis of screening eligibility report on specified date.
  • Subject Attendance in selected project is entered on first come first selected basis on the basis of eligible Screening
  • Attendance sheet keeps track of volunteers when they are enrolled in a study and can be tracked here

  • This module has many sub modules to perform on activities like, ECG recording, Meal, Dosing, Cannulation, Vital, Pre-Post Dose, Discontinuation Form, and Last Sample Date.
  • ECG Recording: Integrated ECG allows user to directly record wave and the values into the system.
  • Meal: Capture meal details and left over of the meals, if any with remark
  • Dosing: With the use of barcode and other technology, it enables to conduct important activities like IP Administration and time point wise sample collection with minimal manual intervention, real-time validations and real-time data collections
  • Cannulation: Captures the details of the Cannula insertion and removal
  • Vital: Captures detail and record for vitals of the subjects
  • Pre & Post Dose: Captures detail of the pre and post dose requirement conditions in set questionnaire form
  • Discontinuation Form: Form allows to discontinue any of the subject in case found not meeting the conditions or fitness or due to any other reason
  • Last Sample Date: Captures detail of the last sample drawn
  • Concomitant medicine: Manage the dosing details of all concomitant medicines as planned

  • Enter details for protocol compliance check as set under study project

  • Facility to do check-in and check-out of the subjects into the project
  • Check-In activities includes many activities that are performed by the respective users as per their roles and rights.
  • Captures detail of the Check-out activities and time into the system

  • Account Set up: provision to manage account set up
  • Transactions: this maintains transaction details between two accounts
  • Milestone setup: is to set up milestones for projects
  • Project milestone setup: module is for setting milestones mapping for particular project period
  • Volunteer Payment: maintains the payment information and history of the payments, payments process happens in this sub module
  • Payment approval: maintains approvals for screening and project payments before making out of set maximum amount criteria. Once approved, then only the extra amount can be paid

  • Centrifugation: Captures the detail of the centrifugation time, who performed and item details based on the barcode
  • Separation: Captures the detail of the sample separation and who performed and item details based on the barcode
  • Sample Storage: Captures the detail of the sample storage in deep freezers with user and sample details
  • Segregation: Captures the detail of the sample segregation with user and sample details
  • Segregation & Storage: Captures the detail of the sample in and out with user and sample (bags) details

  • Allows to generate and print barcodes generated by users
  • Also allows to track the barcode
  • Barcode can be generated for (Staff, Machine, Group barcode, IP, Concomitant, Volunteer, Material and Bags etc.)

  • This module handles the sensitive data change in the system
  • Changes would need approval in order to modify details in the system, so the change request can be approved or rejected once seen by the authorized user

  • Create CDISC(SDTM and ADaM) compliant datasets ready for reporting, analysis and submission
  • Easy setup of SUPPQUAL domains
  • Creation of SDTM-annotated CRF
  • Intuitive graphical user interface
  • Properties and Domain selection of CDISC standards
  • Data submission archive module
  • User interface for SDTM and ADaM data review
  • XPT file generation of clinical data

  • Management of Investigational Product
  • Inventory management of incoming products
  • Tracking and allocation of the products to protocols/projects
  • Accountability reports based on the transactions

  • Project/study creation is done through study setup
  • Project Management helps to manage the projects that are active or inactive at your facility
  • Tracking of scheduling and actual start date of project
  • Activities creation through respective masters
  • Based on the CRF design, sample CRF can be viewed

  • Designing of Informed Consent Form (ICF) as per the need
  • Protocol specific designing of the ICF

  • Volunteer Entry and Exit tracking in premise
  • Accountability report based on the entry and purpose
  • Generation of quick gate pass for identified and unidentified volunteers
  • Provision of tagging into the system before performing operation on Volunteers

  • Provision of raising query within the system by reviewers
  • Track of all changes and closing of queries upon acceptance
  • Independent and project specific accountability reports

Report module helps in pulling out detailed reports and logs based on multiple input parameters and individual reports. Readily available reports but not limited to, based on the real time entries into application.

  • Dynamic & very fast Subject database search feature is provided by the system
  • Subject Database Report (date-wise, quarterly, total, yearly etc.) can be viewed in the system
  • User can search the subjects by biometrics and can access the basic information, habit details, contact details etc.
  • The Details of the subject can be exported to pdf or can be printed directly from the system

  • In case of any downtime, the hard data can always be transcribed and stored into the system
  • Data Transcribe module helps to maintain the recording of hard copy to electronic record
  • It allows to transcribe the data for (ECG, meal, dosing, attendance, breath alcohol test, urine drug test, sample collection, vital, centrifugation, clinical examination and check-in/out.

  • All the user activity is logged in the Audit Trail which is accessible to the all users except Normal User.
  • User can generate full audit trial report, also can export and can generate print
  • View and export audit trail based on the date selection
  • Any change can be easily back tracked
  • Audit trail also maintains the old value to new value logs for easy review

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