clini india-academy of clinical research & management +919231739412;

Clinical Research & Management I Medical Writing I Pharmacovigilance Regulatory Affairs I Clinical Data Management

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Hyderabad I Lucknow I Kolkata I New Delhi www.cliniindia.com

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 globaliza-tion world.

Welcome

CLINI INDIA advances the research of pharma industry, Life science and medical products by developing collaborations between industry and academia. The Institute’s sponsors rely upon its scientific training to add professional value to the design of their studies, oversight of their research and analysis of their study data. As a leading provider of clinical trial services, CLINI-INDIA plays an important role in assessing new products that improve the quality of peoples’ lives. strong relationship with the Pharmaceutical, Healthcare & the Medical fraternity helps us provide intellectual resource to serve the needs of both students and the industry.

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

CLINI INDIA aims to train students and industry professionals by providing training in Clinical Research and Management. We at CLINI INDIA are committed towards developing India as a hub for global CLINICAL RESEARCH by catering to the ever-growing training and compliance needs of the profession, through specialized training courses . Our extensive classroom training with on site practical training in live projects provides you to enter into the Clinical Research Industry. CLINI INDIA team consists of full time professionals from the industry and visiting specialized consultants.


The Drug Development Industry

The Indian pharmaceutical industry is growing at an annual rate of 11 % while the clinical research industry is growing an annual rate of whopping 84 %.

McKinsey estimated that clinical research in the country would be a $1bn ($1000m or €800,000m) industry by 2010 whereas Ernest & Young indicates around $1.5 -2 billion by 2010. Market value for clinical trials outsourced to India is estimated at around $300 million, having increased by 65% in 2006, it is expected to touch $1.5-2 billion by 2010. By 2010, the industry will spend $300million on clinical trials in India.

New chemical entity (NCE) innovation is costly. The average cost of each NCE bringing to market to become a medicine range from $800 million to $2 billion. Cost increases if the NCE causing late stage failures in phase II & phase III. So, it is important conducting trial phases more efficiently with respect to safety, efficacy & quality to reduce late stage attrition cost. The US pharmaceutical market value still 40% of the global mar-ket, expected to grow annually 3% over coming 4 years.


The Drug Development Industry……..Contd.

To make it more economically trial operations from MNC are focusing more on the lower cost countries where qualified physician & patients are available on low cost. Companies reduce their cost per patient by 40-60% and speed up the patient recruitment by 20-30%. As a result Pfizer, Eli-Lilly, Novartis, AstraZeneca, GlaxoSmithKline, Abbott, Wyeth, Bristol- Myer Squibb (potential multinational clinical research sponsor) are significantly increasing their efforts to recruit potential trial investigator (physician) and patients in Eastern Europe, India, and China.

Clinical trials, which represent 40-50% of a new drug’s development cost, take place mostly in the USA, Europe, and other parts of globe. Extending these trials globally offers a huge opportunity not only for cost savings but also for improving productivity, since more than 60% of clinical trials fails their deadlines because they can’t recruit patients quickly enough.

Number of Clinical Trials globally 2013

Sponsors can also afford to hire intellectual capital of lower-wage regions, like trial counselors, clinical research coordinator, nurses to check up on trial participants and encourage them to make trial more compliance. It helps to detect non- compliance at the early stage of trials to make trial more efficient.


The Drug Development Industry –Indian Scenario

Career Opportunities


CLINI INDIA is a integrated platform which provides practical training and resources for Global Life Science industry. Our integrated program comprises of:-

Practical training delivered by industrial experts Program designed to meet current industrial demands Corporate collaborations for best global life science practises. Technology partners and provision of quality resources. Success rate [batches/placements]

Why CLINI INDIA?


Teaching Methodology:

Active learning Literature review Journals study Case Studies Power Point Presentation Poster Presentation Module wise evaluation Assignments Project work Hand on training

Faculty:

Permanent Faculty Industry Visiting Faculty Expert Consultant from Top MNC’s & Global Consulting Services Domain Leaders from IT-Life Science and Healthcare firms

Flexibility:

Classroom E-Learning support Cloud Computing support

Our dedicated placement cell is providing placement assistance to our students for the last 3-4 years. We have successfully placed majority of our past students in to the top MNC’s, CRO, IT companies as well as reputed healthcare organization in INDIA. Our placement cell spontaneously works with students for developing communication skills, analytical capability. We provide importance over personality development & mock interviews.

Placement Cell:

Courses:-


Advanced Program in Pharmacovigilance (APP)

Introduction to clinical research History of clinical research Overview of Drug Development Process Good Clinical Practice, Schedule Y Global Regulatory Environment-Overview. FDA, EMA, ICH Proof of concept, trial design & methodology Clinical Operations Clinical Trial Management, Essential research documents and Regulatory submissions

Advanced Program in Clinical Research & Management (APCRM)

Introduction to clinical research Overview of Drug Development Process Good Clinical Practice, Schedule Y Introduction to Pharmacovigilance Individual Case Safety Reports Periodic Safety Update Reporting Pharmacovigilance Regulatory Environment Safety Data Collection & Systems Safety Reporting System-WHO, FDA, EMA, CDSCO, ICH Post-Marketing Surveillance Signal Generation, Detection & Analysis

A. 3 months class room + 3 months internship for hands on practical experience B. Placement cell Activity– Communication skill, Personality Development, Analytical Capability Development, Mock Interview


Courses:-


Advanced Program in Regulatory Affairs (APRA)

Overview of Drug Development Process Proof of Concept, Trial Design & Methodology Protocol Writing, Case Report Form Designing, Inform Consent Form Clinical Study Reports (CSR) & web synopsis Pre-Marketing Safety Reports - IND ARs, EU ASRs Post-Marketing Periodic Safety Reports - PSURs, NDA PRs/PADERs, Summary Bridging Safety Case Narratives Company Core Data Sheets (CCDS)

Summary of Product Characteristics (SmPC) Patient Information Leaflets Nonclinical & Clinical writing inputs (Modules 2.4 & 2.5 of CTD) Bio-waivers Picketing insert Monograph Abstracts & Manuscripts Proofreading Editing Research Web content Writing

·

Advanced Program in Medical Writing (APMW)

Introduction to clinical research Overview of Drug Development Process I. Drug Regulatory (USA,CDSCO & EMA)

Overview of FDA,CDSCO, EMA Details study of DMF & Dossier Role of Regulatory in Drug Development Types of application and submissions Detailed study of DMF & Dossier Types of registration procedure Difference between US & Europe

Regulatory

II. Devices Regulatory (USA,CDSCO & EMA)

Overview of medical devices & their classification Overview of device master file Procedure of device registration 510(k) & PMA Detailed study of 510(k) & PMA Detailed study of technical master file Procedure of device registration Detailed study of QMS system



Courses:-


Bio- Science/Science/ Pharma/Medical/Nursing graduates ,Post Graduates, students appearing for the final semester or year examination are also eligible .

Potential Participants

Overview of Drug Development Process Good Clinical Practice, 21CFR 11, ICH e-CRF Design Study Set Up Database Creation Data Entry Data Validation Query Management Database lock CDMS AERS EDC CDISC STDM DCF Management

Advanced Program in Clinical Data Management (APCDM)

A. 3 months class room + 3 months hands on practical experience B. Placement cell Activity– Communication skill, Personality Development, Analytical Capability Development, Mock Interview

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 of student will undergo following procedure:

Academic Track Record Personal Interview Screening Test

Testimonial


CLINI INDIA Academy for Clinical Research & Pharma Management Swathi Plaza, Behind Honda Showroom Near Yashoda Hospital, Somajiguda Hyderabad - 500082 Phone - 040- 6555 0643 Cell - +91 7799400500 [email protected] www.cliniindia.com

Hyderabad I Lucknow I Kolkata I New Delhi

Contact Us:

clini india-academy of clinical research & management +919231739412;

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