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CTMS Features
New Subject Initiation
Initiate Subjects for Pre-Evaluation to determine preliminary medical conditions and eligibility for a Study
- Register Walk-in subjects
- Record demography & contact information
- Upload registration forms and signed consents
- Schedule pre evaluation visit
- Create appointment
- Assign responsible staff
- Cancel or reschedule, as required
- Record pre evaluation tests done on subject, and their results
- Move subject to Principal Investigator for review
- Record evaluation notes and flag subject as eligible to move ahead
Pre Screening
Carry out the process of obtaining full medical records of preliminary eligible subject
- Log all actions taken to obtain subject's medical records & medication data from their PCP, other doctors, pharmacy & labs
- ETA based alerts & escalation for effective follow-up, ensuring that medical records are completely and timely received
- Upload all received records
- Review of medical records and charts by PI to establish that subject does not meet any exclusion criteria
- Auto-text assisted note templates to enable PI quickly write review notes
- Pre Screen Fail subjects having exclusions
- Mark subject as eligible to screen for a specified study, if no exclusions found
Pre Enrollment
Begin the process of Enrollment of subjects meeting preliminary eligibility for a study
- Skip pre evaluation & pre screening stages to take subject directly in pre enrollment
- Schedule subject's first visit for signing of ICF
- Schedule other screening procedures on first visit
- Subject auto-enrolled on signing of ICF
- Facility to handle ICF declined & first visit cancellation cases
- CMTS auto-removes pending appointments when subject declines to sign ICF or cancels ICF visit
- Facility to handle case where subject declines to sign ICF for study A and agrees to sign ICF for study B
Subject Enrollment
Manage subject enrollment flexibly through extensive interfaces seamlessly connected to auto scheduler
- Auto-enrollment of subject moving through normal process route of pre enrollment, after they sign ICF
- Facility to provisionally enroll subject and schedule visits, auto conversion to full enrollment as soon as subject signs ICF
- Auto removal of all scheduled visits if subject declines to sign ICF
- Direct enrollment of subject who is already mid-way in study when you started using the CTMS
- Facility to enroll subject in a 2nd study while he is active in one study
- Historical data entry interface to record all enrollment data of past studies
- Screen fail or early terminate subjects, with auto removal of all pending visit appointments
Auto-Scheduler & Calendar
Quickly schedule subject visits via a smart scheduler, adhering to protocol timelines and available window
- Scheduler takes care of availability of resources, namely - staff, equipment and time, and creates a no-clash schedule
- Auto-excludes holidays, off hours, weekends & staff leaves, with facility to force schedule on these days as well
- Option to schedule visit-by-visit, or auto-schedule all or a specified number of visits
- Visit appointments are auto-posted on Calendar
- Various calendar views available - day view, week view, month view, upcoming view - filter calendar views by study, subject and staff
- Facility to manually adjust date and time of auto generated visit appointments
- Facility to auto re-schedule on protocol changes
Post Enrollment Activities
Effectively handle all activities and situations arising during the study process
- Log & track lab-works to ensure timely delivery of lab reports
- Report adverse events and schedule visits to handle them
- Create & manage other unscheduled visits
- Handle protocol amendments, version changes and associated staff training
- Automatic re-consent enforced on every protocol amendment, in immediate next visit of each subject
- Reschedule visits of active subjects, every time there are changes in visits and timelines - changes are instantly applied through automatic scheduler engine, thereby creating error-free schedules without deviating from permitted window
Receivables & Payables
Comprehensive mechanism for auto generation of all receivables and payables, ensuring accuracy in financial data
- Flexibly setup all study receivables and payables
- Set visit and procedure level receivables
- Set triggers for fixed cost receivables and target based incentives
- Set global holdback, with overrides at visit & procedure level
- Define all financial values & triggers during study protocol setup and you are done
- Easy re-conciliation of money received from sponsors
- Facility to handle subject and provider payments
Regulatory Compliance
Carry out quality audit of subject Binders & ensure that they comply with regulatory requirements
- Log audit findings and report discrepancies to concerned study coordinator
- Alert based to-and-fro communication between regulatory specialist and study coordinator until a binder is set in order
- Maintain record of all company credentials - licenses, certificates & registrations. Assign responsible staff and set reminder to remind staff when renewal is due
- Maintain record of all staff licenses & certificates. Specify their renewal schedule and associated staff is auto reminded when renewal is due
Document Storage & Tracking
Store all study documents, medical records, forms and other company documents on the cloud in encrypted form
- Categorize documents as per document types
- Restrict access to documents by document category
- Record all status changes and version changes
- Store all versions of a document on the server
- Quickly retrieve documents as and when needed
Subject EMR & Management
Manage subjects through extensive interfaces provided to record subject data, attach medical records, charts & medication data
- Capture all subject data & files - store securely on server for easy access
- Subject dashboard to enable investigators to conveniently review subject's medical information and charts, and write notes
- Maintain date-wise record of observations of investigators
- Flag subjects into various categories such as - Interested in Study, Future Subject, Not Interested, Not a Candidate
- Smart filter to quickly obtain a list of potential subjects that fit a specified demographic criteria
Doctors Directory & Communication
Create a database of all primary care physicians and other specialist doctors that your subjects would be consulting
- Manage directory of doctors associated with your subjects - smart filter to quickly locate primary care physician of subject
- Communication facility to enable easy communication with PCPs, keeping them informed about status of their referred subjects
- Letter templates to enable auto-generation of customized letters which can be emailed or printed
Study Setup & Management
Setup various types of studies comprehensively through versatile and easy to understand interfaces
- Smart study setup interface that allows to setup various types of studies you conduct
- Record basic study information
- Assign list of staff engaged in the study, along with their roles
- Define protocol of visits and procedures - specify timelines and available window for each visit, assign responsible staff, allocate equipment resource
- Specify all visit level and procedure level receivables
- Define trigger based fixed cost receivables and incentives
- Attach all study related documents
- Setup various types of studies such as - regular, multi-arm, observational & extensions
- Create custom study types and define your own study process flow
- Protocol sanity checker in-built - Helps run basic checks to ensure that study is fully setup before you begin to enroll subjects
- Maintain a master list of all procedures and draw from it while setting up visits protocol
- Facility to mark certain procedures as optional, such as - pregnancy test
- Facility to drop mandatory procedures at appointment interface, such as an MRI not required to be repeated
Staff Management
Create staff and maintain all relevant records needed for them to access the CTMS to effectively operate your clinical trial site
- Maintain a comprehensive database of staff - their qualifications, experience, skills & salary
- Auto computation of staff cost based on defined salary structure
- Staff leave administration - scheduler takes into account availability of staff when creating appointments
- Auto generation of time-sheets & computation of study wise staff time
Users & Access Control
Multi-user system enabling multiple users to simultaneously work on the system
- Role based access permissions, study-wise restricted access
- Multi-level access control ensuring user is given restricted access to subject information and other site information only to the extent they need
- Critical actions such as process reversals and deletions are restricted only to users with administrative level access
Realtime Reports
CTMS generates numerous useful reports, enabling day-to-day monitoring and tracking of research activities
- High level and detailed reporting capabilities, enabling you to identify trends and inconsistencies
- Real-time comprehensive data reporting, helping in smart decision making
- Track study progress in real time
- Get increased recruitment visibility
- Track staff effort, time utilization and costs
CRM & Communication
Communicate conveniently with subjects, caregivers, doctors, staff, providers, sponsors and CROs
- Mass communication mechanism to facilitate email communication with these entities
- Define multiple sender identities
- Create multiple recipient lists using smart filters
- Auto email appointment reminder to subjects and their caregiver
- Auto email birthday and anniversary wishes
- Auto send season's greetings
- Email opt-out facility for recipients
Security, Reliability & Scalability
Deployed on highly reliable, highly secure and highly available cloud architecture on Amazon's AWS infrastructure
- Cloud based scalable architecture - quickly scales up to your needs
- Deployed on multiple servers in multiple availability zones, interacting with each other within a private cloud protected by strong firewall, thereby providing a highly secure and highly available system
- Full encryption of data at rest and in transit, in compliance with HIPAA
- Adheres to regulatory requirements & guidelines through user access controls, enforced processes, and behind-the-scenes tracking through audit trails
Designed by clinical trial experts, our CTMS implements time-tested proven work-flows. It has been designed by principal investigators & study coordinators engaged in clinical trials for years, and developed by IT experts with years of experience in ERP software.
The SAAS based deployment of our CTMS will help you get rid of your own expensive IT infrastructure and move all your processes and documents to a better and secure cloud infrastructure maintained by experts.
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