This document provides an overview of drugs, medical devices, clinical trials, healthcare IT, and regulations. It discusses the types and administration of drugs. It describes medical devices and their types. It explains the objectives, design, and types of clinical trials. It discusses the role of IT in clinical trials and healthcare, including clinical trial management systems and electronic health records. It provides information on the healthcare and clinical trial management systems market. Finally, it lists some key regulating bodies and regulations.

1. Introduction to Pharma and Healthcare IT- Drug, Device, Systems- The era of Human technology
Dr. Anirban Mukherjee. Phd

2. 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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3.  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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4. Medical Device
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5. Medical Device - Types
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6. • 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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7. Clinical Trial – Objective
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8. Pharmacokineticc Studies
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9. Pharmacodynamic Studies
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10. Psychomotor Studies
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11.  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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12.  CTMS
 CDMS
 CDARS
 CDS
 eCRF
 eCTD
 Medical Device Software
 Clinical Trial Measure Software
 Telemedicine
 Could medicine
Clinical trial and IT
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13. Design of a CTMS
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14. Architecture of a CTMS
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15. Architecture of a CTMS Component
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16. Clin. Trial Measure Tools, Games Software
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17.  Test time ~2-3 minutes
 349 straight variable out puts
 140 derived statistical variable
Typical –STM-Measure Output
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18.  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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19.  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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20.  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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21.  EHR
 EMR
 HMS
 HIS
 PMS
 PHRs
 E-prescribing
 Telemedicine
 Telehealth
HealthCare IT
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22. Simplest eHealthcare
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23. Hospital information System
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24. 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

25. EHR Flow
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26. EHR-Module Design
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27. EMR
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28. LIMS
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29. Medical Imaging Software
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30. HIT Interoperability
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31. HealthCare Mosaic- India
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33. • 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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34. • 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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