clinical srat presentation

CONFIDENTIAL 104/11/23

Clinical Trial Management & Clinical Data Management Systems

Technical/Strategic Part - 1


CLINICAL DATA MANAGEMENT - INTEGRATION

LOCAL LAB/S DATA

SAS Drug Discovery(Operational Clinical

Database & Repository)

SAS Analytics(Tables, Listings &

Study Reports)

Medical Coding(MedDRA &WHODD)

Electronic transfer of Lab, ECG & Imaging

data per CDISCmodule

Electronic Data Capture

(EDC application)

TRIAL DATA

Web Access

Online real time access

through J-review

CDMSSubmissi

on by CDISC ADAM

Subm

issio

n by

CD

ISC S

DTM

CTMS(Planning, Recruitment, Budgeting & Tracking)

PROJECT MANAGEMENT

Aris/Argus Global(Pharmacovigilance)

DRUG SAFETY

IVRS

Crystal Reports/COGNOS/

INFORMATCA(Business Intelligence –Reporting)

Patient DiaryPaper/

Electronic/IVR

DATA

DSMB Reports

SMB Reports

CSMB Reports


Clinical Data Management – Resources RequiredIn-house - CDM

DatacenterHw + Sw

SponsorEDC+SAS+Medra

+WHO+MeDra+Costat

Staff

Pharmaco. Sw/Tools

Regulatory Sw/Tools

Pr.Mgt.

In-house – CDM Staffing

• Program Manager

• Study Data Manager

• Content Writer

• CRF Builder

• CRF designer

• Database Programmer

• Data Validation Associates

• Statistical Analyst/Programmer

• Clinical Data Analyst

• Medical Coder

• AE Reporting Specialist

• Quality Assurance


Clinical Data Management – Resources RequiredTechnology-Business Integration of CDM

DM SYSTEM

Sponsor EDC

Statistics

Pharmaco

Lab & External

Pr.Mgt.

Lab DataData Import to CDM Repository (Directory Structure)

SaS & SaS Tools

Imaging Data

Medical Coding

Data Import to SaS

Data Export from SaS

DatacenterDatacenter

Biomarkers & Others

Genetic Data

EDC SYSTEM

INTEGRATED DATA MANAGEMENT SYSTEM


Clinical Data Management System/ProcessCTMSCTMS CDMSCDMS

SpectrumSpectrum

CDMS standardsCDMS standards

CRF dev. & ApprovalCRF dev. & Approval

DM Plan & ApprovalDM Plan & Approval

EDC Application dev. & Appr.EDC Application dev. & Appr.

Study db struct. dev. & approvalStudy db struct. dev. & approval

Validation Verification of CRFs & D.EntryValidation Verification of CRFs & D.Entry

Discrepancy resolution & managementDiscrepancy resolution & management

Electronic File Transmission & ManagementElectronic File Transmission & Management

Medical Coding & ApprovalMedical Coding & Approval

Reconciliation of AE’s & SAE’s Reconciliation of AE’s & SAE’s

Quality Evaluation of Study databaseQuality Evaluation of Study database

Study Db Lock Statistical Analysis & ReportingStudy Db Lock Statistical Analysis & Reporting

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Clinical Trial Management System

Other Services

1. Clinical trial strategy and design development.2. Investigational plan creation.3. Analysis plan development.4. Investigator and site identification, recruitment, and

qualification.5. Study document development.6. Site initiation and training.7. Database development, including EDC options.8. Data and query management.9. CEC/DSMB management.10. Study monitoring.11. Site and sponsor auditing.13. Clinical report generation.14. Presentation and journal article preparation.15. SOP development.16. Comprehensive staff training.


Technical overview of a Clinical Trial Management System

Application Back-end DatabaseDatamart, Datawarehouse

Digital Dashboard for Trial Managers

Business Intelligence Interface

Data


Clinical Trial Management System/Software Integration with CDMS

CTMS Modules

• Project Mgmt.

• Budgeting & Finance

• Patient Management

• Investigator Mgmt.

• EC/IRB Approvals

• Compliance with FDA

• AE Reporting System

• eCTD (electronic Common Technical Document ) an interface for the pharmaceutical industry to agency transfer of regulatory information

CDM Modules

• Project Mgmt.

• EDC

• Pharmaco

• SAS

• Data Analytics

What is needed?A: Data integration with central lab, electronic patient diaries(ePro, IVRS, ECG and other third party applications and databases (including CDMS and CTMS) into one comprehensive software application


CTMS + CDMS + Pharmaco + Regulatory CDM + Pharmaco + Regulatory CTMS + Pharmaco + Regulatory

SpectrumPr.Mgt.

CTMS

Staff

DatacenterHw + Sw

SponsorEDC+SAS+Medra

+WHO+MeDra+Costat

Staff

Pharmaco. Sw/Tools

Regulatory Sw/Tools

Pr.Mgt.

1. Medical Monitor

2. Project manager

3. Chief Investigator

4. Principal Investigator

5. Clinical Research Coordinator

6. Clinical Research Associates

7. Associate Staff


1.1 CRF Design Specifications1.2 CRF Annotation Build1.3 CRF Database design build1.4 CRF Physical Screen Design1.5 CRF UAT Testing2.1 Edit Checks Specification2.2 Edit checks Specification programming2.3 Edit Checks UAT Testing2.4 Medical Coding Setup

DATA MANAGEMENT SERVICESFunctional

1.1 Lab Specifications1.2 Lab Specifications reconciliation checks1.3 Lab Reconciliations Checks programming1.4 Lab Reconciliations Checks programming UAT2.1 ECG Specifications2.2 ECG Specifications reconciliation checks2.3 ECG Checks Specification reconciliations checks programming2.4 ECG Checks Specification reconciliations checks programming UAT 3.1 Diary Specifications3.2 Diary Specifications reconciliation checks3.3 Diary Specifications reconciliation checks programming.3.4 Diary Specifications reconciliation checks programming UAT4.1 PK Specifications4.2 PK Specifications reconciliation checks 4.3 PK Specifications reconciliation checks programming4.4 PK Specifications reconciliation checks programming UAT

SET-UP ACTIVITIES

CRF

External


DATA MANAGEMENT SERVICES

1.1 Double Data Entry(Paper Only)1.2 External Data Vendor management1.3 Data Management Discrepancy Management1.4 SAE Reconciliation with Drug Safety / Pharmocovigilance1.5 Medical Coding [AE, Cocomitant Medication, Medical history]1.6 Investigator Discrepancy Data Management1.7 Monitors Discrepancy Data Management1.8 Clinical Review Discrepancy Management1.9 External Data Discrepany Management1.10 Clinical Review Report Management1.11 Data Mgmt. report Management1.12 Clinical/Data Mgmt. Metrics Report Management1.13 Statistical review Management

CONDUCT ACTIVITIES

DISCREPANCY MANAGEMENT(data entry/tracking, data cleaning, query resolution,

reconciliations, reviews etc.)



1.1 Quality Assurance of Data [Error Rate]1.2 Patients Listings reconciliation including visits1.3 SAE Reconciliation1.4 Medical Coding1.5 All queries resolved1.6 All Data Discrepancies resolved1.7 Lab Data Reconciled1.8 ECG Data Reconciled1.9 Diary data reconciled1.10 PK Data Reconciled

CLOSEOUT ACTIVITIES

Data handling, reviews and QA, QC



1.1 SAS dataset package/eCTD1.2 CRF data package/eCTD1.3 DM Document package/eCTD :

Data Management Plan Data Validation Plan CRF Completion guidelines CRF database annotations CRF Evident Corrections Self Checks Specification (CRF) Edit Checks Specifications (Lab, ECG, Diary, PK)

POST_LOCK ACTIVITIES

eCTD Management

THANK YOU

Satender SajwanGlobal Clinical Data Management / Integration Expert (Business)

Mobile: 732-910-9056

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