Clinimate is a Clinical Trial Management System(CTMS) for Clinical Research Organizations (CRO) for BA/BE study management. It is 21CFR part 11 compliant software with an audit trail ensuring data integrity with views based on date, user, item or activity, and study participant.
Clinimate is a Commercial off-the-shelf or commercially available off-the-shelf (COTS) product. It is a packaged solution that is then adapted to satisfy the needs of the purchasing organization. The customers can do a user acceptance test after selecting the product to check its condition.
The Clinimate CTMS software consists of following software modules and submodules:
The VMS keeps track of volunteer entry, volunteer's registration, screening and participation in studies related to Clinical Research.
The Synopsis and Protocol system creates template-based synopsis and protocol and helps in creating ICF and eCRF document.
The pharmacy module records all the pharmacy activity of receiving the IP with documents, IP Storage, dispensing and Reconciliation. The stores management is in an inventory management software.
The Clinical module is a paperless clinical study management for recording all clinical activities such as study management, protocol training, duty delegation, ICF presentation, check-in, dispensing, meals management, sample collection and storage, subject data recording using online forms, recording events, checkout and all study data related works.
Labmate.net ERP LIMS is Laboratory information management system. The samples sent from VMS, screening and clinical modules are tested and reported using Labmate LIMS software. It keeps all the tests to be done under study and helps to tabulate all the laboratory related reports for report writing.
The Dimager® (Radiological information system) is a RIS and PACS software and keeps all the volunteer X-ray and reports.
This document outlines the features, usability, benefits and implementation. Busysoft is original developer of the products and features. We can also alter features as per User requirement specifications (URS) document. The document also showcases the basic software Key modules and features, complete implementation, resources required, Architecture and implementation scenarios depending upon the type of CRO.
This document is intended for directors and mangers in the field of Clinical research management and helps in record management, daily work planning, management and control of CRO.
The Inventory Man system is an inventory management tool for Indenting.
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:
The Standard features of the product are:
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.
The salient features of the module are:
The system consists of volunteer access management and Volunteer data 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.
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.
Labmate-CTMS allows user to manage volunteer selection based on different category including age, male, female, smoking non-smoking, diet, literacy, BMI, demographic, ethnicity etc.
The system will record all the payment structure depending upon activities in the project. The project milestones achieved are recorded and compensation will be calculated. Receipts and summary reports will be generated by the system.
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.
Detailed screening record search and data analysis functions are available to check data. Searching is the essential function of this module. The module helps in searching for eligible volunteers for specific study requirements based on various parameters.
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:
The synopsis and protocol writing helps to:
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:
eCRFs
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
This module has following sub modules:
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.
The proposed module will have following application features. The IMP Management will be linked to study Number/ Protocol Number.
This module works on clinical study-related activities. These activities involve:
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.
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:
This module is for bioanalytical related activities. The planned software involves following modules.
Material Management
Operations
Inventory
Reports
Matrix
Columns
Working Standards
Solvents & Reagents
Other Consumables
All transaction of In/Out
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
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:
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.
Busysoft can provide customization regulatory guidelines and CRO. The scope of the same can be discussed during our URS discussions.
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.
We will provide the facility of importing of existing volunteer data. This will include