Introduction to Pharma and Healthcare IT- Drug, Device, Systems- The era of Human technology

Dr. Anirban Mukherjee. Phd

Agenda in Sequential Order

Our Body – Back to school

Drug, Medical Device, Clinical Trial

Clinical Trial Design and Types

IT in Clinical Trial

Healthcare

It in Healthcare

Regulation

Ideas

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A substance recognized by an official pharmacopoeia or formulary. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance (other than food) intended to affect the structure or any function of the body.

Drugs can be of different types Medication – Pharmaceutical

Spiritual/religious – Etheogenic

Self-improvement – Nootropic

Recreational

Administration: Bolus

Inhalation

Injection

Insufflation

Oral

Suppository

Sublingually

Topically

Drug

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Medical Device

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Medical Device - Types

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• Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people

• The study can be biomedical or behavioral designed to answer specific questions about interventions (novel vaccines, drugs, treatments, functional foods, dietary supplements, devices or new ways of using known interventions), generating safety and efficacy data.

• • Clinical trials can vary in size, and can involve a single research entity in one country or

multiple entities in multiple countries.

• A full series of trials may cost hundreds of millions of dollars. The sponsor could be a governmental organization or pharmaceutical, biotechnology or medical device company.

• When the required support exceeds the sponsor's capacity, the trial may be managed by an outsourced partner, such as a contract research organization or an academic clinical trials unit.

Clinical Trials

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Clinical Trial – Objective

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Pharmacokineticc Studies

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Pharmacodynamic Studies

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Psychomotor Studies

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Customizable software systems to manage large amount of data involving the clinical trial operation

The clinical trial includes but not exclusive of following data:

Scientific data

Administrative data

Regulatory data

Demographic data

Marketing data

Trial configuration data

……………………..

Software to aid in planning, preparation, performance, and reporting (AE data), keeping up-to-date contact information for participants and tracking deadlines and milestones such as those for regulatory approval or the issue of progress reports of Clinical Trial

Clinical Trial also need to be connected to a business intelligence system, which may acts as a digital dashboard for trial managers

Need of IT in Clinical Trial

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CTMS

CDMS

CDARS

CDS

eCRF

eCTD

Medical Device Software

Clinical Trial Measure Software

Telemedicine

Could medicine

Clinical trial and IT

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Design of a CTMS

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Architecture of a CTMS

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eCTMS Log Ins

Study Mgt

Create

Create Like Create New

Report

Audit TrailSearch Study Report

User Mgt

Study Users

Available Users

Current Users

Permissions

GeneralSchedules

Subject Mgt. Product Mgt. Site Mgt. Financial

Mgt.

Trip report mgt and review functions

Architecture of a CTMS Component

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Accounts Views and Payment Tracking

Overall Project/Study/ Session Expenditure

Tracking

Correspondence Tracking and field Updates

Subjects

Investigators

Fiancial Calculations and Tracking

Financial Mgt.

Clin. Trial Measure Tools, Games Software

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Test time ~2-3 minutes

349 straight variable out puts

140 derived statistical variable

Typical –STM-Measure Output

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The worldwide revenue of the pharmaceutical market in 2001 was around 390.2 billion U.S. dollars. Ten years later, this figure stood at almost one trillion U.S. dollars. And it is ever growing.

Global Clinical Trial Management Systems’ Market valuation is predicted to be $1300.4 Million by 2016.

The global CTMS market is estimated to grow at a CAGR of 14.53% during period (2011-2016).

North America is leading the global CTMS market with around 62% share in 2010, as majority of the global clinical trials are conducted in North America, especially in the U.S. (around 58.5% share).

The second largest market is Europe, while growth in the Asia-Pacific region is also expected to take greater curves in the near future.

Major players in the Clinical Trial Management Systems Market include Oracle Corporation (U.S.), Perceptive Informatics (a subsidiary of Parexel International Corporation) (U.S.), Medidata Solutions (U.S.), eResearch Technology Inc. (U.S.), and BioClinica Inc. (U.S.).

Clinical Trial Management Systems (CTMS) Market: Global Trends, Opportunities, Challenge and Forecasts (2011 - 2016)

The CTMS Market

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Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in human beings.

Health care is delivered by healthcare practitioners, associates and related service providers.

Healthcare services can be extended to primary care, secondary care, and tertiary care, as well as in public health.

Total health care spending in the United States is expected to reach $4.8 trillion in 2021, up from $2.6 trillion in 2010 and $75 billion in 1970. To put it in context, this means that health care spending will account for nearly 20 percent of gross domestic product (GDP), or one-fifth of the U.S. economy, by 2021.

HealthCare

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Health information technology (HIT) provides the umbrella framework to describe the comprehensive management of health information across computerized systems and its secure exchange between consumers, providers, government and quality entities, and insurers.

Broad and consistent utilization of HIT will: Improve health care quality or effectiveness;

Increase health care productivity or efficiency;

Prevent medical errors and increase health care accuracy and procedural correctness;

Reduce health care costs;

Increase administrative efficiencies and healthcare work processes;

Decrease paperwork and unproductive or idle work time;

Extend real-time communications of health informatics among health care professionals; and

Expand access to affordable care

Examples of health IT include the following: Clinical decision support.

Computerized disease registries.

Computerized provider order entry.

Consumer health IT applications.

HealthCare IT

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EHR

EMR

HMS

HIS

PMS

PHRs

E-prescribing

Telemedicine

Telehealth

HealthCare IT

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Simplest eHealthcare

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Hospital information System

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EHR

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EHR Should Contain: Health information and data,

Result management,

Order entry/order management,

Decision support,

Electronic communication and connectivity,

Patient support,

Administrative processes,

Reporting and population health.

EHR is utilized for: Patient Care Delivery

Patient Care Management

Patient Care Support Processes

Financial and Other Administrative Processes

Patient Self-Management

Education

Regulation

Research

Public Health and Homeland Security

Policy Support

EHR Flow

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EHR-Module Design

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EMR

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LIMS

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Medical Imaging Software

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HIT Interoperability

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HealthCare Mosaic- India

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• European Federation of Pharmaceutical Industries and Associations (EFPIA)

• Ministry of Health, Labor and Welfare, Japan (MHLW)

• Japan Pharmaceutical Manufacturers Association (JPMA)

• US Food and Drug Administration (FDA)

• Therapeutic Products Directorate (TPD)

• Pharmaceutical Research and Manufacturers of America (PhRMA)

• --------------------------- (many more)

Controlling bodies

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• 21 CFR (Part11, Part210 and 211, Part820 or Quality System Regulation, Part 807, Part 814 etc.)

• 520(k)/PMA

• GDMP, GMP, CAPA

• The Hazard Analysis and Critical Control Points (HCCP)

• ASTM D1585, ASTM F2097, EN 868, ISO 11607, CE Marking

• HIPAA , ARRA, HITECH Act, EDI transaction and code sets

• HCP Aggregate Spend Reporting, PPACA, Physician’s Sunshine Legislation, US State and Federal regulations.

• CDISC (SDTM and ODM)

• PhRMA regulations

• CRF 42

• ISO 9001, ISO 14971, ISO 13485,

• IEC 62304

Regulations

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