CTIS – Capital Technology Information Services, Inc. Proprietary Information

Information technology and informatics enhancement of

clinical trial programs

Presented byMatthew Seguin, Director of Clinical Knowledge Management

Capital Technology Information Services, Inc.

Shaw Pittman - HealthCare Technology Network Meeting Meeting Topic: Technology for Clinical Trials

on November 19, 2004 in Washington, DC

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Material that will be covered today

CTIS general background information

Critical parts of a IT enabled Clinical Trial Informatics solution

Integration of lessons learned and industry best practice into a

customized working solution

Review of IT enabled ROI in Clinical Trials program performance

Summary

Questions

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Capital Technology Information Services, Inc. (CTIS)

Background Information

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Why was CTIS invited here today?

CTIS provides information technology and informatics support

services for the largest Clinical Trial Networks in the US and abroad. Cancer Therapy Evaluation Program (CTEP)

Division of AIDS Program (DAIDS)

Mr. Seguin is the Director of Clinical Knowledge Management

Systems for CTIS. His principal clients are NIH’s DAIDS and CTEP

programs. He is responsible for providing clinical trial  informatics and

clinical trial management subject matter expertise in the development

of their enterprise-wide information management systems, decision

support strategies, and good clinical practice implementation.

CTIS – Capital Technology Information Services, Inc. Proprietary Information

CTIS’ History and Mission

Contribute to….patients’ well-being….economic benefits….saving patients’ lives

1999 to

2004

•Clinical Informatics•Information Assurance•Data Curation•CTM Consulting •Customized Enterprise System Development•Business Intelligence

• Other Diseases, NIH institutes: NHLBI, NIAID

• AMI, CROs, SMOs

• Pharma Companies

• TrialBridge Components

1993

to 1998

•Health Informatics•Clinical Trials Mgmt.•Data Warehousing•Enterprise Architecture•Decision Support Services

• Cancer, NCI and NIH

• Information for Protocol, Audit, Site, Regulations, Sponsor Physician, patients.

• Safety, Efficacy and Efficiency

1985 to

1992

•IT Services•IT Integration•Application Develop•Industry Consulting

• Energy, Environment, Health and R&D

• Data Management & Decision Support

• Int’l Development

• Financial Engineering

1969 to

1984

•Information Science •Communication Plans•Mgmt Consulting •Technical Services

• Clearinghouse & Outreach

• Policy and Strategy Development

• Event Management

• Documentation & Publishing

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Critical parts of a IT enabled Clinical Trial Informatics solution

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Web enabled Data Warehouses

An agile and flexible Operational framework

Evaluation and Implementation framework

Web enabled Digital Dashboards

Configurable components

Electronic Data Capture for patient encounter information

Tools to facilitate tasks such as Protocol development and

approval

The most frequently requested Modules for a CRN Integrated Informatics solution are:

CTIS – Capital Technology Information Services, Inc. Proprietary Information

More INDs and Agents are processed through the CT process

Efficient and effective use of available resources

Open communication practices

Workflow improvement without re-engineering the process

Reduce resource duplication and enhance throughput

Empower the people to manage change

Embed quality measures

Standardized compliance frameworks

Share information across infrastructures

Hospitals and resource poor clinics trial participation

These Clinical Research management Modules need to address key business realities or desires

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Rapid exchange of concepts and protocols

Avoid service fragmentation

Manage strategic direction implementation

Facilitate workflow

Enhance information sharing

Reuse existing infrastructure

Enable oversight, monitoring, and measurement capabilities

Dynamic maintenance of Standardized Operating Procedures

Demonstrate a measurable ROI soon after implementation

These key business realities or desires are enabled through IT solutions that are highly efficient and effective

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Many Clinical Trial Informatics driven programs have 12 objectives, which are:

Optimization of the clinical research process Building of awareness and outreach Capacity building and training Information flow and management processes Resource allocation and optimization Regulatory compliance Standards management Safety management and reporting Oversight and monitoring framework SOP framework Interface with Support organizations Stable and Standardized IT infrastructure backbone

These solutions will to map to key CT program objectives and will help drive Informatics solution

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Integration of lessons learned and industry best practice into a customized working

solution

National Cancer Institute, Cancer Therapy and Evaluation Program

and

National Institute of Allergy and Infectious Disease, Division of AIDS Program

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Informatics experts work with Clinical Trial professionals to baseline business requirements

Regulations &Standards

Protocol

Electronic Data

CRFs

Patient CRFs

Laboratories

ImageWorkflowData Capture

Dictionaries Coding

Validation/Derivation Rules

TRIAL DESIGN

Trial Plan Administration

TRIAL SETUP

Trial Design

Trial DataDefinition

TRIAL CONDUCT

SOAP/ DISCO

Tracking

TRIAL ANALYSIS

Snapshots Monitoring

GlobalLibrary

DataCollection

DataValidation

Reporting

LabSystemXML

SAEs

ICFs

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Implement IT industry best practices into each informatics solution

developing better ways to diagnose, treat and prevent the many infectious,

immunologic and allergic diseasesDataset

DefinitionsCTRM

Workflow

CTRM Enterprise

Models

BusinessRules

Web

Database DesignSoftware Modules

Client

Web

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Current IT implemented Informatics solutions are assessed & aligned with CIO’s strategic plan

CTRM - Enterprise Database

AdEERSOutcomes

SystemGrants

Management

100111010010

100111010010

100111010010

100111010010

100111010010

ClinicalData System

100111010010

100111010010

100111010010

Accrual AER Treatment Grants

PublicationsDatabase Drug Repository

DSMB FDAIRB

International Research

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Devise Informatics solutions that empower Clinical Trial and Program Management professionals

CTRM - Enterprise Database

How many grade III or higher SAE's have been reported in the past year, for subjects enrolled in clinical trials of anti-retroviral drugs in the US vs. Sub-Saharan Africa, what were they and how were they distributed by SAE type and across gender and race? 

Query Analyzer

EIS

011011001100

SQL

Query in English

Output in Multiple output formats

Aligned with CIO strategic plan

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Review of IT enabled ROI in Clinical Trials Performance

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Cancer Therapy Evaluation Program (CTEP) Informatics driven - Performance History

Performance element 2003 1999 Five yearsNumber of IND - Annual 172 117 47%Number of agents - Annual 950 734 29%Level 1 38%Number of patients - Annual 567,854 290,472 95%Number of drug orders - Annual 55,197 26,837 106%Number of treatment courses - Annual 18,658 4,262 338%Level 2 180%Number of active organizations (sites) - Annual 7,717 4,297 80%Number of active investigators - Annual 12,822 10,641 20%Number of protocol increases - Annual 8,308 2,500 232%Number of adverse events reported - Annual 5,000 2,960 69%Level 3 100%Processing time from LOI to protocol activation-days 240 550 56%Time to submit FDA annual report-days 40 120 67%Level 4 62%Time from when AE occurred to Reported-days 67 130 48%Clinical data upload time-days 10 45 78%Level 5 63%

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Summary

Customized IT CT systems can help professionals manage change

Identification business process restrictions opens up IT options

Work in partnership to target problem areas and devise solutions

Align current systems with CIO strategic plan

Implement proven & applicable Industry Best Practice solutions

Link business process vital signs to Digital Dashboards

Implement modular configurable components

Create and standardize interoperable enterprise IT architecture

Guarantee data accuracy throughout a secure chain of custody

CTIS – Capital Technology Information Services, Inc. Proprietary Information

CTIS Contact Information

Matthew Seguin

Director of Clinical Knowledge

Management

One Research Court Suite 200

Rockville, MD 20850

Office: (301) 948-3033

Chris Stathes

Executive Vice President

One Research Court Suite 200

Rockville, MD 20850

Office: (301) 948-3033

CTIS – Capital Technology Information Services, Inc. Proprietary Information

Questions