Clinimate (Labmate Clinical Trail Management System)

The System has been designed to work as per industry standard requirements. It has seamless integration with clinical laboratory management system. The main modules of the product are:

• Volunteer Management with registration
• Medical screening
• BA/BE Study Management
• Master Data management with master parameters
• MIS and Summary reports
• Laboratory information Management System
• Data Management and Archival of Reports
• Medical/ Protocol writing with automatic eCRF generation
• Clinical Study Report generation conforming to CDISC standards.
• Project (BABE study) management and monitoring module. Enabling client or sponsor wise/ study wise management for ensuring project or sponsor timelines.
• Clinical Study Inventory and stores management for various consumables at clinical and bioanalytical.
• Include "Pharmacy module" which includes Investigational Medicinal Product (IMP/ IP) management (IMP receipt, identification, accountability, usage for study and retention), IMP labeling (customizable) for study specific usage as per the labeling guidelines.
• Integration with SAS (ver9.3 or higher) and Winonlin softwares for statistical data incorporation into clinical study reports available.

The Standard features of the product are:

• Audit trail maintenance on Masters and transactional activities
• User security based on user level with security of all menu options and buttons
• Data export in various formats such as DOC, PDF and Excel
• Compliance as per 21CFR part 11 on data confidentiality and user security

These guidelines serve as reference point for designing CTMS. Their main objective is to act as a standard to facilitate acceptance and auditing of clinical trials by the regulatory authorities. We have drafted a subset of these guidelines that are desirable functionalities for the prospective system.

• Implement security measures and protocols that prohibit unauthorised access to the study and data.
• Provide adequate audit trail to ensure that all changes pertaining to the conduct of the trial are well documented.
• Incorporate features to encourage the consistent use of clinical terminology and to alert users that data is out of range.

 

• Provide suitable safeguards to isolate identifiable information from the study and ensure that retrieved data regarding each subject is only attributable to that subject.
• Provide satisfactory backup and recovery protocols to guard against data loss.
• Provide support for several data types such as dates, text, numerical values, and various image formats such as pdf, jpeg, png, BMP, video files, and Dicomimages..
• Facilitate data extraction and the ability to generate reports swiftly.
• Uphold the cost-effectiveness of the system.
• Endorse minimal development efforts
• Advocate an advantageous type of licensing.
• Promote adherence to industry standards, such as the Clinical Data Interchange Standards Consortium (CDISC).

Volunteer Management System

The salient features of the module are:

• VMS and cross participation software (OVIS) interfacing.
• Direct import of laboratory reports, ECG and X-ray(Complete paperless screening process).
• Enlisting of screening pass/ fail volunteers.

The system consists of volunteer access management and Volunteer data management system.

Volunteer Access Management System

Volunteer is tracked from the time of entry at the gate. System checks the purpose of the volunteer visit and issues a gate pass. The volunteer status is checked from the central database is directed for screening, volunteer registration or other activities such as payment.

Volunteer Data Management System

Volunteers are the significant features of clinical research. The software provides the selection procedure of volunteers as per regulatory requirements of the project or study, maintaining identity confidentiality.

Labmate-CTMS provides a platform for volunteer/patient registration. Biometric Registration uses Volunteer verification and identification. It provides complete volunteer details accession to ensure subject safety while conducting a study and ensures quality in the subject enrollment process.

Labmate-CTMS maintains a database of the registered volunteers and their information in the system. A unique Volunteer ID Number (VIN) is allotted automatically to the registered volunteer. VIN Number helps to search for all the volunteer information.

Volunteer Screening

Medical Screening of the volunteer is the most important starting step of clinical trial and BA/BE study. The volunteer or Patient are screened prior to the project starts as per project criteria. The volunteers clearing the screening process are enrolled into the project as subjects in adherence to the regulatory guidelines.

Labmate-CTMS provides a solution to conduct this screening process electronically. The screening records can be stored and easily retrieved whenever needed. Based on this screening the volunteer or patient is found eligible to enroll into the study.

Labmate-CTMS allows to generate the electronic screening records in printable format and also other reference documents can be attached along with the Screening records.

Volunteer Screening Features

• Management of screening
• Capture of Screening consent
• Allows to capture generic screening for each screening record
• Scan all basic examination information HME

Synopsis and Protocol Writing

Writing robust Synopsis is a clear roadmap for a clinical trial. The investigator needs to have a relevant outline so all the involved parties can review the required direction the clinical trial has to go. Investigators use a synopsis to check if the study is feasible and the resources required,and other support to undertake the study. It helps in designing a study protocol based on regulatory authority.

The process involves:

• Selecting a predefined template for the synopsis
• Filling the required parameters
• Saving the synopsis in defined document format
• Submitting the document to sponsor and related stake holders
• Allowing saving the multiple versions of the document
• Saving the required comments and changes by each stake holder
• Final approval of the synopsis
• Preparing of Clinical Trail Protocol Document

The synopsis and protocol writing helps to:

• Properly define the study goals and designs
• Quantitative measurements required (endpoints-outcomes) for each participant.
• Subjective endpoints by investigators
• Determine complexity of the trial
• Method for recruiting and enrolling participants
• Performing the study
• Gathering and analyzing the data
• Define the measurable objectives
• Develop the testable theory for the experiment
• Look for similar research experiments to help the project and research
• Helps to find the experiment subjects with inclusion and exclusion criteria

This module provides Synopsis writing on the basis of predefined reusable templates. These templates can be categorized on basis of regulatory authorities. The client-based synopsis and Protocol writing including initial protocol (draft) preparation and circulating for user/ technical inputs with thorough audit trail of user inputs and version control for both draft and as well as final versions. Complete paperless end to end module which supports automatic eCRF preparation by automatically extracting relevant information from final protocol with scope of QA review for protocol review and approval of Protocol and eCRFs.

The salient features are:

• Prepare Synopsis with Version control and parameters
• Protocol writing in line with ICH GCP (E6) requirements for various submissions.
• Built-in pre-defined templates or customizable templates.
• Complete Protocol version control and record of all protocol inputs from various departments during finalization of protocol.
• Automatic generation of eCRF from protocol.

eCRFs

• ICD with mandatory fields is auto generated taking key information from final protocol.
• CRFs are auto generated taking information from final protocol.
• Pop-ups to check for invalid data will be incorporated.
• Option to develop eCRFs using CRF databank with already validated pop ups
• UAT prior to launching the eCRFs for every study (by QA and CU, BA etc.).
• SDTM generation and integration into clinical study reports.

Study Management

Clinimate BABE Study management system manages all trial activities in a planned and effective manner and in regulatory compliance with GLP, GCP, ISO-15189 and 21CFR Part 11. Each user has to do the activities by accepting the same using biometric identification of finger prints. All the activities are audit trailed keeping record of user, date time and system on which the activity took place.

Clinimate can manage multiple sites involved in the clinical trial and the trial data as collected by the respective sites. It allows online data transcription which reduces the risk of data lost, wrong data entry

• Allow to create BABE/clinical trial Study
• Allows Volunteer call contact management
• Manages subject enrollment at different sites
• Generation of barcodes for dosing and sample collection
• Generation of worksheets for stations
• Reminder on work schedules
• Assign random subject numbers
• CRF and event management with printing
• Tracking of the study progress
• The station can record volunteer activities using barcode readers, including ambulatory mid-study tests and pre and post-dose timings.
• Discrepancy Management System
• Edit-check final summary reports on deviations
• Create Study and record parameters
• Volunteer enrollment in study, communication

Functions

Study Creation and Scheduling

• The main activities start from study creation and scheduling along with study parameters such as period details, ambulatories, Study specific tests required, Midstudy and EOS parameters
• All the study activates are also recorded using the study schedules created during study creation.
• This includes station wise pre-and post-dosing schedules, sample collection schedules, ECG schedules, Vitals Schedules.

Study IP Details

• The option shows the IP details as per Approved Protocol.
• The option records IP components for test and reference drugs.

Randomization Schedule

• The record contain reference to software and version number which created the randomization schedule.
• The record containsa reference to the software and version number, which created the randomization schedule.
• It records the actual randomization schedule for all the subjects.
• A scanned copy, excel, pdf, or Word document of the schedule for reference purposes is attached.

Volunteer Enrollment in Study

• This function allows the user to select available pool in volunteer data base as per the study parameters such as sex, age, BMI, rest period etc.
• It allows only the eligible volunteers to be added for the study
• The user can communicate with selected volunteer for willingness to participate. SMS or telephonic communication details can be recorded.
• On Arrival of the volunteer a volunteer is verified using finger print biometric.
• User can order special tests for volunteer.
• Consent forms can be issued to each volunteer for participation in the study for acceptance.
• Subjects are enrolled in study and subject number is allotted
• Subject identification card printing as per user specifications
• Subject registers, document printing.
• Video recording of informed consent for each individual subject

This module has following sub modules:

• Search Available pool and communication
• Volunteer call for study and (Order special tests)
• ICF and 1:1 Presentation
• Check vitals and drug of abuse
• Study enrollment and allotment of subject no.

Data Analysis and Reporting

The proposed system can export the data from database, CRF to excel, word using the various data fields. The data export option can provide the data export to SAS as well. The data can be exported on the basis of each subject. Special filters can be applied to selectively export the data. Labmate is capable of generating clinical study reports as format requirements to various regulators/ countries such as USFDA.

Pharmacy Module

The proposed module will have following application features. The IMP Management will be linked to study Number/ Protocol Number.

IMP Receipt

• Quantities received
• Expiry dates
• Manufacturing details
• Storage conditions
• How the package was received
• Temperature logger recordings import.
• For how many studies which studies
• Scan & store sponsors covering letter
• Scan and store COA
• Scan & store other relevant documents
• Record of damaged IPs
• Photograph of packaging
• Emailing discrepancies (if any)/ receipt to sponsor.
• Labelling of IP boxes for storage in pharmacy
• Record of which cupboard the IP is put into

Study Labelling

• Automatic preparation of Labels with Mfg., Storage, study No, subject number, Test or Reference, PI Name, Date of Dosing and Drug Name & strength, Tablet/ Syrup/ Capsule/ Powder/ others
• Label printing

Dispensing Activity

• Line Clearance by QA via Tab.
• What time the drug was retrieved from pharmacy cupboard
• Dispensing Start time and End time
• Dispensing what product (Test or Reference)
• Dispensing for which Study
• Dispensed for which period

• Quantities dispensed
• Quantities remaining
• QA Verification and approval via Tab

Accountability and Reconciliation

• Quantities left after study
• Quantities dispensed and used for study
• Quantities dispensed but NOT used for study
• Quantities dispensed for study as standby
• Quantities dispensed as standby and used for study.
• Study Completion date
• Packaging of remaining IPs and sealing date and time. With label print for seal

Pharmacy Room

• Room Temperature and Humidity monitoring
• Record of deviations

Clinical Study Management

This module works on clinical study-related activities. These activities involve:

Protocol Training and Study Duty Delegation

This sub-module is designed to assign roles and activities to all the related team members (Users) for the study. Each team member can be given specific training programs for conducting the study as per the delegated roles. Each delegated user has to accept the roles using a finger print biometric device.

Study Working and Followup

This sub-module records all the clinical study activities the current period. The activities record the timinings, deviations and reason of deviations if any. During each activity any dropout, withdrawal, compliance status, are also recorded along with time.

The activities in study working during the housing period includes:

Check-in

• Check in start
• Items received from volunteer
• Personal kit issued
• Printing of SID card
• Check in finish

IP Receive

• The pharmacy department issues stored IP dispensing box. This option helps in acknowledgement of the box received by the clinical study department for dispensing.

Meal Distribution

• Receipt of meal
• Subject wise weight and distribution of meals as per meal management software.
• Recording of meal start and end time.
• Recording of left-over meals
• Calculation of meal calories consumed as per the meal management setup during study

Predose Vital

• Recording of Predose vitals and deviations

Pre Dose ECG

• Recording of Predose ECG with function of directly capturing the recording or attaching ECG file, recording of deviation and reason of deviations.

Orthostatic Vitals

• Recording of vitals and deviations

Restrictions

• Recording of restrictions along with deviations if any

IP Dosing

• Recording of IP dosing as per randomization schedule along with details of deviations and reason of deviation.

Co-Admin

• Co dosing of other medicines.

Adverse Event Recording

• Records each adverse event type, date and time, resolution for any subject.

Postdose Vital

• Recording of post dose vitals and deviations

Post Dose ECG

• Recording of post dose ECG with function of directly capturing the recording or attaching ECG file, recording of deviation and reason of deviations.

Post Dose Sample

• Recording of Post Dose sample taking for each subject along with barcode printing. It records each timing and deviations if any.

Dropout/Withdrawl

• Recording of dropouts and withdraws of the subjects including reason of doing so.

Check Out

• Check out start for the period
• Items are returned to volunteer
• Personal kit issued is taken back
• Check out finish

Ambulatory

• Ambulatory Sample collection at each station and point wise
• Pasting the barcode
• Recording of drug of abuse, Alcohol breath analysis, pregnancy test, vitals check, physical examination
• Clearing the Subject fit for study

Return Back IP

• This option is for returning back the IP unsed during each period dosing activity.
• It also records the user details to whom it was handed over.

EOS Test Registration

• This option records the subjects for EOS test registration in case if the study requires.

MID Study Test Registration

• This option records the subjects for Mid study test registration in case if the study requires.

Study Completion Status

• This sub-module records the final status of study completion of each subject for a period in a study. This data is the final step and helps to include the subject data in MIS and report writing.

Bio Analytical

This module is for bioanalytical related activities. The planned software involves following modules.

Operations

Material Management

• Matrix
• Columns
• Working Standards
• Solvents & Reagents
• Other Consumables

Operations

• All transaction of In/Out handling of material
• Temperature Logging
• Weighing Activity
• Generate and Export Injection sequence (Batch) to LC-MS/MS
• Method Development
• PRE-MV
• Partial Validation
• Full Validation
• Subject Analysis
• Deviations
• Incident Management

Inventory

• Barcoding of instruments
• Calibrations
• Preventive maintenance
• Breakdown & Malfunctions & Repairs

Reports

• Import of data (from software)
• Chromatograms Import(from Software)
• Interpretation of values & results
• Pre-MV report
• Partial MV report
• MV Report
• Study Report
• Addendums to reports
• QC and QA Review of report
• Export to Medical report
• writing module.
• Archival of data.
• Auditor Mode

Material Management

Matrix

• Receipt(Quantity received/ Type of matrix received/ Expiry Date/ Documents upload (CoA etc)/ Aliquoting)
• Storage (-20°C or -80°C/ Location/ alarms on expiry/ alarms on deviations)
• Usage (Deduct upon consumption during “Operations”)
• Accountability/ Discard

Columns

• Receipt(Types/ Document uploads)
• Storage (Barcoding)
• Usage (Deduct upon consumption during "Operations")
• Accountability/ Discard

 

Working Standards

• Receipt(Types/ Quantities/ Document Upload/ Expiries/ Re-Test/ Alerts for Precaution/ Photo of CS)
• Storage (Barcoding)
• Usage (Deduct upon consumption during “Operations”)
• Accountability/ Discard/ Controlled Substance (CS) monthly usage statements)

Solvents & Reagents

• Receipt(Types/ Expiries/ Document uploads/ MSDS/)
• Storage (Barcoding)
• Usage (Deduct upon consumption during "Operations")
• Accountability

Other Consumables

• Receipt(Types)
• Storage (Barcoding)
• Usage (Deduct upon consumption during "Operations")
• Accountability

All transaction of In/Out

• Samples/ Columns/ Matrix/ WS/ Calibration Kits
• Deep Freezer/ Refrigerator/ storage location usage with reason for In and / or Out.
• Identifying and storage location allocation of for specific projects

Temperature Logging

• Integration with Eurotherm/Radix | Import of temperature at below stages or for "Material Management"

Weighing Activity

• Integrate weighing balance for Import of data from WB to Busysoft

Generate and Export Injection sequence (Batch) to LC-MS/MS

• For MV/Pre-MV/Partial MV/ Sample Analysis

Method Development

• MD Number allocation | MD Personnel Selection | MD Preparation (Stocks/ Reagents/ Solutions/)
• MD Experiments | MD Results | MD Finalisation report and transfer to Pre-MV or Full MV | Literature Upload

PRE-MV

• Pre-MV Personnel Selection | Pre-MV Preparation (Stocks/ Reagents/ Solutions/)
• Pre-MV Experiments | Pre-MV Results | Pre-MV Finalisation report.

Partial Validation

• Par-MV Personnel Selection | Par-MV Preparation (Stocks/ Reagents/ Solutions/)
• Par-MV Experiments | Par-MV Results | Par-MV Finalisation report.

Full Validation

• MV Number allocation | MV Personnel Selection | MV Preparation (Stocks/ Reagents/ Solutions/)
• MV Experiments | MV Results | MV Finalisation report.

Subject Analysis

• Study Number import/ allocation | Study Personnel Selection | Study Preparation (Stocks/ Reagents/ Solutions/)
• Study Experiments | Study Results | Study Finalisation report | Termination

Deviations

• Study/ NTF/ SOP/ Investigations

Incident Management

• Recording of incidents during working

Labmate.net ERP LIMS

The Labmate LIMS is integrated with the volunteer data management system, screening and study management system. All the orders generated at various levels, flows into Labmate. The system takes care of sample collection, Laboratory analyzer interface, result reporting and authorization. The results can be accessed at various departments as soon as the Laboratory releases the results. Additional options are available for booking of patients such as staff and other organization work.

The system also provides linking with various analyzers mainly, Laboratory analyzers, ECG machines and Radiology equipment's such as digital x-ray.

The Labmate LIMS salient features include:

• Good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality and integrity of all kind of tests.
• Maintain ISO Standards and Accreditations
• Keep Non-conformance (NC) in check and keep its record
• Keep audit trail
• Keep record of corrective actions and preventive actions (CAPA)
• Lowest level of inventory without expiry
• Proper training to Employees for competency

This can be achieved only by integrated planned software covering all aspects of Laboratory Management. Labmate.net ERP LIMS integrates all data and processes of an organization into one.

 

Customization and Development of Modules

Busysoft can provide customization regulatory guidelines and CRO. The scope of the same can be discussed during our URS discussions.

Validation and Documentation

Busysoft will provide qualification documents for validation of system (IQ, OQ and PQ) with proper documentation as per regulatory guidelines. Specialized templates can also be used as per guidelines of CRO.

• IQ-Installation Qualification - This document is written as per the hardware and software environment provided by CRO. This will ensure that the procured and installed components are as per required specifications. The document will help in recovery and reinstallation of system.


• OQ-Operational Qualification - This document will test all the intended activities and functions of the system. All the menus, functions, buttons, reports will be tested as per the roles and responsibility set for various users. This will also test business logic. Special care is given to security levels allotted to users.