WO2014033747A4

WO2014033747A4 - Method and system for integrated clinical trial management

Info

Publication number: WO2014033747A4
Application number: PCT/IN2013/000485
Authority: WO
Inventors: Nidhi SAXENA
Original assignee: Karmic Life Sciences, Llp
Priority date: 2012-08-06
Filing date: 2013-08-06
Publication date: 2014-12-11
Also published as: WO2014033747A2; WO2014033747A3

Abstract

Accordingly it is a principle object of the present invention to overcome the disadvantages and limitations of prior art methods and systems and provide an integrated method and system for Clinical trial management. In accordance with the principles of the present invention wherein the system will carry associative functions of the method for Integral clinical trial management. It is yet another object of the present invention to provide common platform for various clinical trials.

Claims

AMENDED CLAIMS received by the International Bureau on 08 September 2014(08.09.2014)

1. A method of integral clinical trial system comprising the steps of:

receiving user identification inputs;

authenticating the user for secured access;

profiling each unique user through analyzing and processing data;

capturing and storing user defined inputs on various user platforms;

generating and maintaining the study masters;

generating and maintaining the site masters;

generating and maintaining the sponsor masters;

generating and maintaining the vendor masters;

generating and maintaining the Partner CRO masters;

generating and maintaining the SMO masters;

extracting and searching the electronic trial master fife based on the user input defining the test from the masters;

creating pre-feasibility search to finalize the site investigator list;

building and administering the site study feasibility to obtain final study feasibility report; creating clinical project plan by selecting clinical project activities in scope from listing of clinical project plans;

creating site strategy and visit plan;

creating IP plan;

creating QA and study audit plan;

creating communication plan;

creating escalation setup;

creating role management plan;

creating and managing budget;

creating monitoring plan for monitoring site;

capturing the patient trial data from the study sites respective to the study plan

storing received input data from the plurality of testing sites synchronizing the processed input data with patient / sites profile of the plurality of patient / sites to formulate synchronized data packet carrying patient trial data

constituting any new study specific IVRS / IWRS requirements transmitting the entire trial master file in an electronic format in structural folders with a directory structure for updating the missing document from electronic from master file to the site master file monitoring project budget;

reporting plan decision;

reporting budget decision;

reporting portfolio or tracer view;

maintaining the repository for storing and management of study documents; and

creating, maintaining and establishing the dashboards for various reports.

2. The method as claimed in claim 1 wherein the user identification inputs are received through the user Interface terminals.

3. The method as claimed in the claim 1, wherein the authentication of the user for secured access is through user interface module.

4. The method as claimed in the claim 1 wherein the administrator module is configured for profiling each unique user.

5. The method as claimed in the claim 1 wherein the step of generating and maintaining study master comprising steps of constituting and integrating various sub masters such as listing of studies, Define Sponsor Team, Define Karmic Team, Define CRO Team, Select Vendor & Update Vendor Contacts, Define Task Ownership Matrix, Select Sites / Investigators) / Support Staff / IEC, Define Procedures (Lab Procedures / Study Procedures), Define Approval Matrix, Define Study Manual (Start-up Plan, IP Plan, Comm Plan &

Annexures), Define Monitoring Plan (Monitoring, Site Plan, Select Visit Schedule)

6. The method as claimed in the claim 1, wherein the extraction of the electronic trial master file based on the user inputs defining the test is through electronic trial master file module.

7. The method as claimed in the claim 1 wherein the step of generating and maintaining site master comprising steps of constituting and integrating various sub masters such as Listing of Sites, Define

Therapeutic Area for Area, Define Site Contact, Define EC Languages, Define Investigator, Define Support Staff, Define SMO.

8. The method as claimed in the claim 1 wherein the method comprising steps of receiving user identification data from a plurality of users, each of the plurality of users providing Input at a user interface module through a secured user access, receiving the input from the user interface module, mapping the input with a plurality of master templates at a master unit, selectively fetching preferred master templates from the plurality of master templates, the master templates fetched based upon pre-determined rules embedded in the master unit and request from at least one of the plurality of users displaying the preferred master templates to the user at the user interface module, storing received input data from the plurality of users for the displayed preferred master templates, processing the received input to convert the received input into a compatible format, receiving the feasibility search request from the plurality of users wherein each of the plurality of users provide plurality of parameters for filtering the site, investigation data, preparing the site feasibility questionnaire based on the plurality of parameters, short list a plurality of sites, add feasibility scoring, generation feasibility matrix; Select clinical priority plan based on the plurality of user inputs, creating the scope of the study based on plurality of details fetched from the respective master, creating site strategy plan based on the study plan, creating quality assurance study audit plan, scheduling study audit for internal customer deliverables and SLA, storing country wise regulatory bodies and regulatory details, receiving inputs for the clinical trial from the user, extracting required regulation details, further extracting masters from the master module as per the study plan based on the user Inputs and the respective regulatory details, receiving study plan and respective site details at EDC/CDMS Module, capturing the patient trial data at EDC/CDMS from the study sites respective to the study plan by mapping the input with a plurality of master templates as configured in the study plan by selectively fetching the master templates from the master units, displaying the preferred master templates to the sites to capture patent trial data, storing received input data from the plurality of testing sites for the displayed preferred master templates, processing the received inputs to convert the received input Into a compatible format, synchronizing the processed input data with patient / sites profile of the plurality of patient / sites to formulate synchronized data packet carrying patient trial data, updating the synchronized data at a memory unit of the data capture unit, constituting any new study specific IVRS / IWRS requirements including study design, sample size, study period, treatment arms/cohorts, visit schedule, dose calculation/modification schedule, IP Plan etc. pertaining to Randomization Schedule Generation and IP Management activities for the said study, receiving from the eTMF module the entire trial master file in an electronic format in structural folders with a directory structure as per the ICH-GCP clauses and guidelines, creating and reporting plan based on inputs from the eTMF module and study plan; creating budget plan based on the plurality of inputs such as user sponsoring defined budget inputs, updating the plurality of payment data, creating risk management plan based on plurality of parameters described through the study plan, site strategy plan, ETMF inputs, budget inputs, creating monitoring plan based on the plurality of inputs such as user defined inputs for the start and end date, budget, etc., review and compare the site master file against the electronic trial master file during monitoring visits and update and reconcile the two on the fly by updating the missing file from site master file onto the electronic trial master file or updating the missing document from electronic from master file to the site master file, transporting and updating trial master file respective to the site master file in a plurality of electronic format, storing user profiles of the plurality of users, periodically updating the received input data and generated report, generating and maintaining dashboards as per the user defined inputs and the study plan configuration and report generation as per the study plan configuration.

9. The method as claimed in the claim 8 wherein the steps of capturing the patient trial data from the study sites respective to the study plan comprising step of mapping the input with a plurality of master templates as configured in the study plan by selectively fetching the master templates from the master units, displaying the preferred master templates to the sites to capture patent trial data, storing received input data from the plurality of testing sites for the displayed preferred master templates, processing the received inputs to convert the received input Into a compatible format, synchronizing the processed input data with patient / sites profile of the plurality of patient / sites to formulate synchronized data packet carrying patient trial data, updating the synchronized data at a memory unit of the data capture unit.

10. The method as claimed In the claim 1 and claim 8 wherein the step of constituting any new study specific IVRS / IWRS requirements pertaining to Randomization Schedule Generation and IP Management activities comprising steps of processing the input received to create Central Depots(s) and Site Entities, set-up the entire Inventory Plan for the study pertaining to Randomization Schedule Generation and set-up the entire Inventory Plan for the study pertaining to IP Management activities for the said study, provide access of Randomization Schedule, IP Management activities to allow authorized users to review and approve respective plans, logs and schedules at each step of the randomization and IP management process.

11. A system for integral clinical trial, the system comprising:

a user interface module, the user interface module configured for receiving user identification data for identification of plurality of users and authenticating secured access to the user; an admin module, the admin module configured to create roles, to assign permissions to roles, to manage features based on roles, to manage actions based on roles, to configure menu items, create a new trial/study wherein Trial Name and unique protocol id may be mandatory parameters for every trial; a master module, the master unit configured for allotting at least one of a plurality of master templates to each of the plurality of users and mapping the received input data with a plurality of master templates;

a CTMS module, the CTMS module comprising of

a feasibility module, the feasibility module to generate site feasibility study and report plan;

a CPP module, the CPP module to generate study plan; a Budget module, the Budget module to generate Budget plan;

a Monitoring module, the Monitoring module to generate monitoring plan; and

a synchronisation unit to control and synchronise the functioning of the CTMS module.

The EDC/CDMS Module comprising of a communication module configured for receiving data input from the site; a memory unit configured for storing and updating the received input at the Electronic/Paper Hybrid Data Management unit; a processor comprising Study Builder module, Electronic/Paper Data Capture & Verification Module, Query management module, Medical Coding module, Data Loader module, Quality Check, DB Lock, SDTM Mapper, and Data Extraction module an Interactive Voice / Web Response module, the Interactive Voice / Web Response module comprising of voice and data communication module and a display module constituting user input -output interface, memory constituting the database to store, maintain and update study specific IVRS / IWRS requirements and Randomization

Sub-Module processor an electronic trial master module, electronic trial master module configured for transporting and updating trial master file respective to the site master file in a plurality of electronic format. a Repository module, the repository module comprising of server, the server configured for storing user profiles of the plurality of users, periodically updating the received input data and generated report; a Dashboard and report module, the Dashboard and report module to generate and maintain dashboards as per the user defined inputs and the study plan configuration and report generation as per the study plan configuration; and a Regdex module, the Regdex module to store country wise regulatory bodies and regulatory details;

12. The system according to claim 11 wherein the user interface module comprise of user I/O module for receiving inputs from the user and user authentication module wherein the user authentication module receives input from the user I/O module, fetches the identification details from the administration module and provide secured access when user inputs results in to valid inputs. For invalid entries the module prompts user for the predefined times and then locks the user account.

13. The system according to daim 11 wherein the administration module configures the system and controls overall operation of the systems to create roles, to assign permissions to roles, to manage features based on roles, to manage actions based on roles, to configure menu items, create a new trial/study wherein Trial Name and unique protocol id may be mandatory parameters for every trial,

14. The system according to claim 11 wherein the master Module comprise of Lookup stacks for storing master templates and LUS configuration and extraction logic to configure and extract the master templates in accordance to the requirement.

15. The master module of the system as claimed in the claim 11 , wherein the master module is configured for allotting at least one of a plurality of master templates to each of the plurality of users and mapping the received input data with a plurality of master templates.

16. The system according to claim 11 wherein the feasibility module of the CTMS module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data - master mapping and integration logic to map the data to the respective sub-masters , constituting the Master.

17. The system according to claim 11 wherein the CPP module of the CTMS module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data - master mapping and integration logic to map the data to the respective sub-masters , constituting the Master.

18. The system according to claim 11 wherein the Budget module of the CTMS module comprise of an Input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data - master mapping and integration logic to map the data to the respective sub-masters , constituting the Master.

19. The system according to claim 11 wherein the Monitoring module of the CTMS module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data - master mapping and integration logic to map the data to the respective sub-masters , constituting the Master.

20. The system as claimed in the claim 11 wherein EDC/CDMS Module is comprising of a communication module configured for receiving data input from the site; a memory unit configured for storing and updating the received input at the Electronic/Paper Hybrid Data Management unit; a processor comprising Study Builder module, Electronic/Paper Data Capture & Verification Module, Query management module, Medical Coding module, Data Loader module, Quality Check, DB Lock, SDTM Mapper, and Data Extraction module configured for processing the received input to convert the received input into a format compatible with the Electronic/Paper Hybrid Data Management unit, processing further to maintain and update the data at the memory in compatible format to that of the other interacting modules; and a synchronization unit configured for synchronizing the processed input data with user profiles of the plurality of users to formulate the synchronized data packet carrying user defined data.

21. The system as claimed in the claim 11 , wherein the Interactive Voice / Web Response module comprising of voice and data communication module and a display module constituting user input -output interface, memory constituting the database to store, maintain and update study specific IVRS / IWRS requirements and Randomization Sub-Module processor configured for processing the input received to create Central Depots(s) and Site Entities as well as set-up the entire Inventory Plan for the study pertaining to Randomization Schedule Generation and IP Management activities for the said study to allow authorized users to review and approve respective plans, logs and schedules at each step of the randomization and IP management process.

22. The system according to claim 11 wherein the electronic trial master module comprise of optical reader interface to capture data and communication module to communicate to the site.

23. The system according to claim 11 wherein the Dashboard and report module comprise of lookup stacks to store the dashboard and report templates and the final generated dashboard and reports.