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CLINI INDIA

Welcome .

In an era when exponential growth of clinical research industry is providing the platform for the life science students, it becomes increasingly important to select an academy that offers the courses relevant to both the current and future employment in the globalization world.

CliniIndia is dedicated to providing its student with a competitive advantage and the capacity for the advancement in the highly growing business of clinical research.

Our vision is to provide the excellence in education for professions, strategic and applied research and flexible delivery of learning and teaching methodology. Our mission is to enhance communities with national and international scholars and institutions with whom our staff and students are linked.

CliniIndia places a strong emphasis on input from industry and professional group to ensure our students have the right combination of theory and practice to be competitive in the global standard in clinical research. Through well developed and proactive links with these groups , our students can confidently embark upon their professional career with the knowledge that they will be well received by employers in clinical research around the world.

The academic benefits offered by the CLINI-INDIA are supported by rich learning experience that our industry faculty provides. We would be delighted to welcome you as a student in this exciting learning…… Team CLINI INDIA

Why Choose CLINI

INDIA? Clini-India is a progressive and premier academy in clinical research that has rapidly gaining a good reputation for excellence through its innovative approach in clinical research. Clini-India is an academy with a good reputation in clinical research industry. CliniIndia is a premier institution of CR education in clinical research domain. CliniIndia delivers Full time, Part time and e-learning training in Clinical research education.

Clinical Research Clinical Data Management Pharmacovigilance Medical writing Medical monitoring

Clini-India aims to train students and industry professional by providing training in clinical research and management. It advances the research in pharmaceutical industry, life science and medical products by developing collaboration with industry and academia. The academy’s sponsors rely on its scientific training to add professional value to the design for the students.

CliniIndia and India India has numerous players in clinical research industry with a global standard infrastructure and manpower. The no of player in CR industry has risen to over hundred from less than 8, three years ago. India has one of the largest patient populations for most of the diseases with genetic diversity. Availability of highly qualified medical practitioners is attracting conduct of global clinical trials in Indian hospitals and clinical sites since India has implemented GCP as per ICH global standards. It is now possible that the data from conduct of trials in India as per GCP guidelines maybe submitted for approval of the drug in USA, Europe, Japan, etc along with submission to authorities in India.

Why Study at Clini

India?

Placement Cell CliniIndia provides you a Pre Placement training, which makes you ready for industry. Our dedicated placement cellworks for corporate training ,industry visit, soft skill development and Resume development. Students Completed courses at Clini India are successfully working in various India and Multinational Companies. Management Curriculum CliniIndia provides the management training to the students to make them ready for the industry. Our

courses are developed in collaboration with industry representative to ensure that the skills of our students acquire meet industry need. Industry Professional Clini-India dedicated to excellence in the delivery of higher education in clinical research. Our academics are supported by well researched curriculum and teaching methodologies that maintains a high level of satisfaction among all the students, employees and academy partners. Your Future All students are encouraged to look their studies from a global perspective, considering social and ethical factors. This in turn will help them make informed decision throughout their life. Industry faculty We at Clini India ensures you to meet and interact with industry professionals, will help you to understand the Clinical Research IndustryScenario

Clinical

Research

Clinical Research

Clinical research is a branch of medical sciences that

determines the safety and effectiveness of medicines,

devices, diagnostic products and treatment regimens

intended for human use. These may be use for for

prevention, Treatment, Diagnosis or for relief of symptoms

in a disease.

The New Beginning

The fats evolving world offers new business processes and novel job

opportunities, but not all can expect to provide a promising future, though

market in clinical research is certain to grow forever, making clinical research

a wise decision for rewarding future.

Improving Life & Enhancing career

As a clinical research professional you will be a part of various drug

development process designed for improving health for society. This

emerging career also offers a lucrative career and fast track growth. The

perfect balance of self growth as well as service towards society makes a

career in clinical research more attractive.

Due to some alarming episode raises concerns about drug safety all over the

world. It triggered continued efforts attempting to balance the risk faced by

the subjects participating in a drug trail and the benefits that mankind would

accure by the new drug under scrutiny.

Clinical Trail: an organized Trial Clinical Research is an organized trial of a new drug conducted on the human being to determine the safety and efficacy of a new drug.

A Phase One Study: Phase I studies are primarily concerned with assessing the drug's safety. This initial phase of testing in humans is done in a small number of healthy volunteers (20 to 100), who are usually paid for participating in the study. The study is designed to determine what happens to the drug in the human body--how it is absorbed, metabolized, and excreted. A phase I study will investigate side effects that occur as dosage levels are increased. This initial phase of testing typically takes several months. About 70 percent of experimental drugs pass this initial phase of testing.

A Phase Two Study: Once a drug has been shown to be safe, it must be tested for efficacy. This second phase of testing may last from several months to two years, and involve up to several hundred patients. Most phase II studies are randomized trials. One group of patients will receive the experimental drug, while a second "control" group will receive a standard treatment or placebo. Often these studies are "blinded"--neither the patients nor the researchers know who is getting the experimental drug. In this manner, the study can provide the pharmaceutical company and the FDA comparative information about the relative safety of the new drug, and its effectiveness. Only about one-third of experimental drugs successfully complete both phase I and phase II studies.

A Phase Three Study: In a phase III study, a drug is tested in several hundred to several thousand patients. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the drug's effectiveness, benefits, and the range of possible adverse reactions. Most phase III studies are randomized and blinded trials. Phase III studies typically last several years. Seventy to 90 percent of drugs that enter phase III studies successfully complete this phase of testing. Once a phase III study is successfully completed, a pharmaceutical company can request FDA approval for marketing the drug. Post-Marketing -- Late Phase Three/Phase Four Studies

In late phase III/phase IV studies, pharmaceutical companies have several objectives: (1) studies often compare a drug with other drugs already in the market; (2) studies are often designed to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) many studies are designed to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies.

Why India? A fast growing destination

India is home for vast reserve of knowledge and resources based and strategically located in the arena of global clinical research and trails .India’s potential as a favorites outsourcing destination has led many pharma companies to set up clinical research business here.

Advantage India

Career Development

Courses Full Time and Part Time Advanced Program in Clinical Data Management Introduction

Strong knowledge of CR & CDM, familiarity with system development processes and general computing as relates to pharmaceutical development. The data management and database design principles and exposure to requirements for statistical computation regarding layout and presentation of data which exposure to principles of computer validation, testing, and system integration concepts.

Course Goals: Apply project management concept to the work Recognize and implement strategies for effective CRO management Describe the rationale for FDA standardization & recognize what impact it has on daily work Apply better medical coding practices to your projects

Eligibility Criteria: B.sc/M.sc Life Science (Microbiology, Genetics, Biotechnology, Zoology, Chemistry, Botany, Biochemistry), BPharm, MPharm, MBBS, BDS, BAMS, BHMS, Pharma & Clinical Research Professionals, IT or Statistics background.

Note: The Manager of Clinical Data Management manages CDM activities to ensure the successful completion of projects and achievement of departmental goals. This includes: • Providing technical guidance to the data management staff. • Prioritizing responsibilities and supervising employee development. • Serving as a primary resource and point of contact for departmental staff, project managers, line managers, executive staff and clients.

Course Content: --------------

Clinical Trial Process Clinical Trial Design Ethics & Good Clinical Practice Clinical Data Management CRF Design Data Entry Data Collection Data Load Data Storage Data Validation Query Management Data Archiving Quality Systems, Sops & Audits Regulatory Affairs & Compliance Safety Management and Pharmacovigilance Statistical Analysis & Reporting Data Management Systems & Tools CDMS AERS EDC Analytical Tools Documentation & Document Management System Medical coding and medical dictionaries Project Management Security systems

Practical Clinical Data Management System Study Set-Up Database Creation CRF Creation Data Entry Data Validations Query Management Database lock Statistical Software

ADVANCED PROGRAM IN CLINICAL RESEARCH AND PHARMACOVIGILANCE: ------------------------------------------------------------------ Designing of Clinical Trials:

----------------------------

Investigators and sites Selection of investigators and sites, visits, initiation and close out.

Statistical Elements Sample size, randomization, coding

Trial subjects Recruitments, withdrawal drops out

Pharmacokinetics & Drug Interactions: -------------------------------------

Overview Definitions and Concepts

Pharmacokinetics Selection of volunteers, planning and design of studies

Study conduct Inclusion/exclusion criteria, sampling and analysis

Quality and Responsibility QA & QC, responsibilities of staff, drug accountability

Drug Safety & Pharmacovigilance: --------------------------------

Overview Definitions and Concepts, DSMBs

Pharmacovigilance SAE, safety, Guidelines, Methods, Forms

Managements of Clinical Trails : ------------------------------

Drug Safety Post Marketing studies, PSUR, package inserts

Overview Project managements, objectives, task network

Project Resource Resource and supplies, drug supplies, distribution

Finances Budgeting, Costing, Over Runs, Insurance

Non Compliance Misconduct and fraud, detection and management

Trial monitoring Objectives, Procedures, Reporting

Audits and Inspection: --------------------- Overview Quality systems, SOPs

Audits & Inspections Audits, conduction and reports

Regulations Study repots, trails, electronic signatures

Clinical Research Process Outsourcing:

-------------------------------------

Overview Concepts, economics

CROs Roles, responsibilities, advantages

Outsourcing Project managements, agreements, partnership, future trends.

Drug Discovery & Development: ---------------------------

Preclinical Evaluation Drugs Screening, HT screening, animal pharrnacology

Biometrics Dose response. relationships, bioassays, MIC and. FIC

BAIBE Studies Design sampling, analysis and parameters

Evolution of New Drugs Pre clinical and clinical development, drug development process,

regulatory controls, marketing

Regulatory Requirements: -----------------------

Good Manufacturing Practices GMP, quality assurance and quality management

Quality, adulteration, misbranding

Laws Drugs and Cosmetics Act, Patent laws, regulatory environment in US and EU

New Drug Law Schedule Y

Clinical Research Process: -------------------------

Overview Definitions, Clinical trials introduction

Ethics in clinical research Principles of ethics. IRB, Nuremberg Code, declaration of Helsinki, ICMR Guidelines

Stakeholder in CR Roles and responsibilities

Guidelines ICH- GCP, Indian - GCP

Clinical Trials Objectives, goals, strategies and tactics

Regulatory Trials Phases of Clinical Trials

Documentation in Clinical Research: -----------------------------------

Protocol Development, review, amendments

Informed Consent Forms Development, review, amendments

Brochures Investigator & Patients Development, review, amendments

Case Record Form Development, filling, datac1arification

Admission

Procedure

Eligibility Minimum eligibility criteria for application to the course would be either of the following:

Applicants are recommended to have one of the following life Science degrees: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics)

Selection Procedure To maintain high academic standard, the Institute gives due importance to the quality of students enrolled. To ensure this, the selection of individual student will undergo the following procedure:

Personal interview

Screening and selection of students

CONTACT US: CLINI INDIA Swathi Plaza, Rajbhavan Road, Somajiguda, Hyderabad 500 082 040- 65550643 077 99400500