Clinosoftresearch

Clinical Research:

Clinical Research is a branch of Healthcare science that determines the safety and effectiveness (efficacy) of the medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention treatment diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. The term clinical research refers to the entire bibliography of a drug/device/biologic, in fact, any test article from its inception in the lab to its introduction to the consumer market and beyond. Also referred to as Clinical trial management

Clinical Research is an attractive industry which foresees tremendous growth and job opportunities for trained medical, pharmaceutical and paramedical professionals, Life Science Graduates, regulatory authorities, government and the society at large. With the inflow of multinational players in research, the industry is poised to grow exponentially and open up new vistas of employment for a large number of people. Clinical Research is a quick getaway to jump start your career/get a job since the learning curve is minimal.

With Global joints like Quintiles IMS, Novartis, Paraxel, GSK, Inventive Healthcare much more such companies setting up their global or Asia pacific operations out of India which further augurs well with the growth potential in the Clinical Research sector within India as well. Clinical Research has many facets and the majority of them are CTM, PV, MW, SAS and RA departments. See pic.

Clinical Research Overview

Introduction to clinical research
Drug discovery process
Phases of clinical trials
Randomization
Different players involved
Different types of clinical trials
Clinical trial process
ICH-GCP
Schedule Y

Clinical Data management:

What is Clinical Data Management?

When new drugs or devices are tested in humans, the data generated by and related to these trials is known as clinical data.

Definition of Clinical Data Management:

Clinical data management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management assures collection, integration and availability of data at appropriate quality and cost.

CLINICAL DATA MANAGEMENT is a process of ensuring that data collected during a clinical trial is…

Accurate
Complete
Logical
Consisten

Objectives of CLINICAL DATA MANAGEMENT:

That collected data is complete & accurate so that results are correct.
That trial database is complete, accurate & a true representation of what took place in trial.
That trial database is sufficiently clean to support statistical analysis & its subsequent.

Clinical Data Management Overview

Clinical Trials and drug discovery introduction
Principles of Clinical trials
21CFR part 11 introduction
GCP (Good Clinical Practice Principles
Clinical Data Management introduction
Clinical Data Management phases
Start-up Phase introduction. Conduct Phase introduction
Discrepancy Management
Data set validation review
Offline Listing review
All third party vendor reconciliation
SAE reconciliation
Study close-out phase introduction and activities

Pharmacovigilance:

Drug safety or Pharmacovigilance is in the spotlight of new drug development. This carves a vital niche inside the expanding pharmaceutical business. It would be apt to say that as much as pharmaceutical business is evergreen, the pharmacovigilance is ever greener.

Objective of Pharmacovigilance

Proactive monitoring and reporting on the quality, safety and efficacy of drugs,
Assessment of the risks and benefits of marketed medicines,
Monitoring the impact of any corrective actions taken,
Providing information to consumers, practitioners and regulators on the effective use of drugs,
Designing programs and procedures for collecting and analysing reports from health care professionals (HCPs), patients, relatives, lawyers, journalists etc.
Early detection of unknown/unexpected safety problems,
Detection of increases in frequency of Adverse Drug Reactions (ADRs) to a drug, in patients/subjects treated with this medication,
Identification of risk factors for ADRs,
Risks Analysis & Mitigation
Benefit-Risk balance

Pharmacovigilance Module overview

Introduction to PV
Process of PV
The PV Jargons
GVP
Narrative Writing
A. E. Reporting
Pharmacovigilance in India
Medical Coding

Medical Writing

Medical writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research. A medical writer, working with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe research results, product use and other medical information. The medical writer also makes sure the documents comply with regulatory, journal, or other guidelines in terms of content, format and structure. Medical writing as a function became established in the pharmaceutical world because the industry recognized it requires special skill to produce well-structured documents that present information clearly and concisely. A growing number of new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This drives a demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly.

Medical Writing Course Contents :

Introduction to Medical Writing.

Clinical Trial Terminologies and Definitions.

Clinical:

Clinical Trial Protocol.

Clinical Study Reports.

Informed Consent Form, Case Record Form.

Regulatory/Labelling:

Preparation of PIL/PI/SmPC.

Clinical and Nonclinical Overviews and Summaries.

Justification document, Addendum, Bio-waiver Justification.

Core Data Sheet/ Core Safety Information.

Publication:

Journal/Abstract.

White Paper Presentation.

Medico-Marketing:

Continuous Medical Education, Physician Desk Reference

Regulatory Affairs

Pharma regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry.

The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:

pharmaceuticals
Medical devices
In vitro diagnostics
Biologics and biotechnology
Nutritional products
Cosmetics
Veterinary products

The regulatory professional’s roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and post market surveillance.

CDISC

SDTM (Study Data Tabulation Model)

CDISC overview and Standards
SDTM Introduction and SDTM IG
Explaining SDTM Controlled Terminology (code list)
Types of SDTM variables and core values
SDTM variable categorization and Importance
SDTM Domain Categorization and importance
Brief explanation on Special Purpose domains
Brief explanation on Events class domains
Brief explanation on Findings class domains
Brief explanation on Trial Design domains
Explanation on SDTM Standard Vs custom domains
Explanation on SDTM Standard Vs custom domains

SDTM Hands on Experience (Real time):

SDTM Mapping Specification
SDTM annotation
SDTM Domain creation by using SAS Programming

ADaM (Analysis Data Model)

Introduction to ADaM
Basic Idea about SAP and mock shells
Creation of ADaM datasets (ADSL) by SAS
Creation of Tables, listings and Graphs

SAS

Introduction about SAS
Getting into SAS windows environment
Base-SAS Products
Basic structure of SAS Programming
Reading of inline/external data in SAS
Handling of duplicates & nonstandard data
Creation of SAS Libraries
INFILE statement Options
INPUT Methods
Using of Informat and Format for non-standard data
Global and Local options
Customization of process by using options & statements
ODS (Output Delivery System) concept
Conditional Statements in SAS
Usage of Operators in SAS
Combining of SAS datasets
IF /ELSE statements and Do loop
MERGE / APPEND
Special Rules for Variable Names dataset names

SAS functions:

Data step functions
Arithmetic/Numeric functions
Aggregate functions
Character/string functions
Date & Time functions

Usage of Procedures in SAS:

PROC PRINT
PROC SORT
PROC IMPORT
PROC EXPORT
PROC FORMAT
PROC TRANSPOSE
PROC MEANS
PROC FREQ
PROC TABULATE
PROC REPORT
PROC SUMMARY
PROC UNIVARIATE & more...

Advanced – SAS:

PROC SQL
MACROS
GRAPHS

Medical Coding Course Syllabus:

Complete Anatomy and Physiology of the Human body systems
Medical Terminology
Comprehensive training on ICD-10-CM Guidelines with live examples
Current procedural Terminology (CPT)
Healthcare common procedural coding system (HCPCS)

Continued education
Willingness to learn new concepts.
Self-learner and self-motivated
Flexible to work in shifts
Basic computer skills
Organizational skills
Logical thinking
Patience to review and understand the medical records.
Should maintain HIPAA policy (confidentiality of patient’s records).

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