ABOUT US AIMS & OBJECTIVES

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2 ABOUT US THE ALCHEMY INSTITUTE provides a transformational experience to its students who are expected to maintain the highest standard of personal integrity, professional commitment and business ethics. Life at the institute is a fantastic social experience which develops a sense of belongingness to the community among students and makes cross-cultural interaction easier in their future lives. We take care to inculcate these values among our students while shaping and sharpening their mindsets by the academic rigor of our programs. Due emphasis is placed on exposing our students to real-life situations of the corporate world and facilitating interaction with the best minds in the industry and with those who have helped achieve their missions with strong ethical undertones. Our Professional Courses emphasizes on the combination of core business subjects and soft skill courses which lead to total personality development of the students. Our Institute represents a unique educational setting to encourage students to meet the complex scientific, technological, and ethical challenges we face as we head into the 21st century. At Alchemy we provide the perfect environment for developing and nurturing a scientific career. We're constantly working to ensure our research services provide the clients with the best scientific support required. The mission of the Institute is to promote cross-disciplinary ethical research and education encompassing the biological, chemical, and engineering disciplines. I hope you find the information within this website/prospectus both interesting and informative and if you would like any further information please do not hesitate to get in touch with any of the members of Alchemy team. New fields are emerging that focus our curiosity, creativity, and interconnections. Join us in their innovation! AIMS & OBJECTIVES Aims & Objectives To bring remunerative, more affordable, high quality and skill based education for all human beings. To simultaneously spread this kind of education to all parts of the globe at a rapid pace. To constantly monitor, manage and upgrade the programmes. Expansion of Higher education opportunity To produce energetic, effective, employable, efficient and ethically driven graduates and post graduates to serve the society To provide quality education and training in Paramedical Allied Health fields and Super Specialties. To pursue excellence in the fields of Medical and Natural Sciences and in life itself. To promote and encourage biotech education and research by training future teachers, research scientists and managers for the industry. Vision To be a premier, world-class center for higher education and research in life sciences. Recognizing the need for skilled man power in the exponentially growing clinical research and allied service industries, our tailor made training course include both hands on and classroom based instructions and are customized to the individual needs of each client. Mission Alchemy's mission is to improve health and quality of life by collaborating with academic and industry partners to conduct high quality clinical research in a professionally nurturing and worldclass academic environment. To provide postgraduate education. To carry out research and development in various domains of science and engineering. To create centers of excellence to foster cutting edge research. Quality Policy It is the policy of Alchemy to provide our students the superior quality knowledge and meet the highest standards of performance. We provide the satisfaction and exceptional values to our students 2

3 CLINICAL RESEARCH OVERVIEW The term clinical research refers to the entire biography of a drug from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the drug (including its efficacy and toxicity) are studied. Phase 1 trials Phase 1 trials usually deal with investigating the studied drug in a minor number of research subjects who are healthy volunteers. This phase is mainly targeted at identifying the safety, tolerability, and the general mechanism of the action of the drug in humans. Phase 2 trials The goal of phase 2 trials is to grasp additional understanding of the studied drug's safety and efficacy. It also determines the appropriate dose to be administered to deliver the desired treatment effect while minimizing the safety risk of future research subjects. This usually requires more than 100 patients to demonstrate relevant results, Phase 3 trials This phase often exposes more than 1000 research subjects with the disease, and is usually performed at many clinics (sometimes well over 100) to enroll the trial (or trials). There is a focus on the effectiveness of the study drug in a variety of demographic and socioeconomic subjects with variants of the disease under study. A comparison is usually made with standard drugs available on the market. It is imperative that the drug is shown to be effective and safe in this phase. Phase 4 trials In phase 4, the aim is to further characterize the safety of the drug through the identification of unknown adverse reactions and to potentially research new therapeutic indications. Companies often use this phase to gain exposure to different physicians and clinics, which aids in the marketing of their product. Further trials Clinical research continues throughout the lifetime of the drug to include post marketing surveillance where a periodic 'progress report' is submitted to the regulatory authorities once every 2 years after the drug is released into the market, and Pharmacovigilance where the safety of marketed drugs, biologics or medical devices are monitored. The focus of clinical research is wide enough to include important items such as data management, medical writing, regulatory consultation, and biostatistics. 3

4 INDIAN SCENARIO India is today poised as one of the favorable destination for conducting global clinical trials due to the availability of large patient populations, skilled manpower, cost effectiveness, favorable economic & IP environment etc. Clinical research is a highly specialized field that requires specific training to carry out various job functions. The need and complexity of the specific training at the level of CRA(s)/Monitor(s)/QA Auditor(s) increases as they move up the professional ladder thereby shifting the focus from trouble shooting to planning & forecasting. Increasing disease awareness and research to find newer & novel solutions to the maladies experienced by the mankind has opened up wide vistas for a relatively new field in the healthcare management Industry Clinical Research. All major pharmaceutical companies and clinical research organizations will need the services of professionally trained clinical research professionals. All these factors indicate a huge demand for professionally well-trained clinical research professionals in India and abroad. Clinical Research Organizations (CROs) which have been active internationally are now making a beeline towards India which offers a wide & varied genetic pool along with skilled professionals. The fast expanding operations of CROs has given rise to a huge demand for bio-science graduates with an understanding about the industry and its operations. THE ALCHEMY INSTITUTE is aimed at imparting basic to advance level skills on various clinical research topics (such as Drug development & clinical trial process, GCP guidelines, Clinical trial monitoring, Drug regulatory affairs etc.) in order to train & develop clinical research professionals by imparting quality education to them. Program Objective(s) To provide an in-depth training & opportunity for skills development on Clinical Trial Processes. To uncover the hidden pitfalls of clinical study process for a sound milestone planning and execution of the study in a time bound & flawless manner. To nurture the culture of 100% GCP & regulatory compliance at any time-point. Competency development. Courses at Alchemy 1. PG Diploma in Clinical Research 2. PG Diploma in Clinical Data Management 3. PG Diploma in Pharmacovigilance 4. PG Diploma in Clinical research - Cosmeceuticals 5. PG Diploma in Clinical research - AYUSH 6. Certificate Programs : ICH GCP, Monitoring 7. Corporate Training Programs 8. Ethics Committee Training on GCP, SoP 9. Seminars and conferences 4

5 P G Diploma in Clinical Research (PGDCR) About the course: The PGDCR course at THE ALCHEMY INSTITUTE is a 6 months weekend course. It focuses on the essential principles of Clinical Research and standard regulatory controls necessary to study the safety and efficacy of a drug. The course content has been reviewed and approved by Clinical research experts and academicians where more emphasis is laid on Planning, conducting, monitoring and generating information as per global standards and regulatory requirements. Students are not only trained in Clinical Research but there is a special focus given to Management & Soft Skill learning. Duration: 6 months Mode of Training: Classroom & Distance / Online Eligibility: Graduate or Postgraduate in Life sciences/ Microbiology/ Biotechnology/ Pharmacy/ Medicine/ Nursing/ Physiotherapy/ Dentistry/ Homoeopathy/ Ayurvedic and Veterinary Science, Interns and Working Professionals. Contents: Module 1 Module 2 Module 3 Module 4 Module 5 Introduction to Anatomy, Physiology & Pharmacology Introduction to Clinical Research Regulatory Affairs and Quality Assurance Data Management and Project Management Project Total Fees: 1. Classroom Rs. 35,000/- 2. Distance Rs. 10,000 ( Fees includes Admission fee, Study Material & Exam fee) Exam and Evaluation: Based upon assignments after each module and Final written exam Career prospects Career prospects include a professional career in the Clinical Research Industry. Companies are appointing qualified professionals for the various designations given below. Clinical Operations CRO s/pharma Companies Site Management Organizations Data Management CR Training Institutes Clinical Trial Assistant(CTA), Clinical Research Associates(CRA), Clinical Team Leader, Project Manager, Medical & Regulatory Manager, Quality Assurance Manager, Medical Director, Associate Director, Director-Business Development, Director/Head (Clinical Operations), General Manager/CEO/ President Clinical Research Coordinators(CRC), Principle Investigators/Co-Investigators, Medical Monitors, Project Manager, Medical & Regulatory Manager, Quality Assurance Manager, Manager-Business development, Medical Director, Associate Director, Director/Head(Clinical Operations), General Manager/CEO/President Data Entry Operator, Data Manager, QA Executive, QA Manager, Statistical Programmer, Bio-Statistician, Data Reviewer, Medical Writer, Head-Data Management Trainer-Clinical Trial Management, Trainer-Data Management, Trainer- Biostatistics, Trainer-GCP Regulations, Trainer-Project Management, Training Coordinator, Training Director 5

6 About the course: Post Graduate Diploma in Clinical Data Management (PGDCDM) Clinical Data Management is a branch of Clinical Research concerned with managing and processing the data gathered during clinical trials. It includes hands-on training on SAS, Data Management, Coding, Database Designing & Validation Procedure Writing. Clinical Data Management (CDM) is recognized as the crux of Drug Development process. It satisfies the specialized needs of the critically important Drug Development in terms of quality, accuracy, verifiability, consistency and above all, conformity to local regulations, and GCP. CDM plays a vital role in Drug Development and Clinical Trials. It assures integrity & quality of data being transformed from trial CRF to database system. Duration: 6 months Mode of Training: Distance/ Online Eligibility: Graduate or Postgraduate in Life sciences/ Microbiology/ Biotechnology/ Pharmacy/ Medicine/ Nursing/ Physiotherapy/ Dentistry/ Homoeopathy/ Ayurvedic/ Veterinary Science/ Statistics and IT, Interns and Working Professionals. Contents: Module 1 Fundamentals of Clinical Research and GCP Guidelines& Other Regulatory Guidelines Module 2 Essential documents and documentation in Clinical Research Module 3 Clinical Data Management, Data Storage & Archival, Quality Systems, SOP S & Audits Module 4 Project Total Fees: Rs. 10,000/ Exam and Evaluation: Based upon assignments after each module and Final written exam 6

7 About the course: Post Graduate Diploma in Pharmacovigilance (PGDPV) Pharmacovigilance in concerned with the development of science and regulation in the area of drug safety. It aims at detection, assessment and prevention of adverse effects and other medication related problems. The PGDPV course at THE ALCHEMY INSTITUTE covers entire array of topics that are related to pharmacovigilance: Clinical research and ethics, basics of adverse drug reactions, principles of pharmacovigilance and the regulatory perspectives. Duration: 6 months Mode of Training: Distance Eligibility: Graduate or Postgraduate in Life sciences/ Microbiology/ Biotechnology/ Pharmacy/ Medicine/ Nursing/ Physiotherapy/ Dentistry/ Homeopathy/ Ayurvedic/ Veterinary Science/ Statistics and IT, Interns and Working Professionals. Contents: Module 1 Module 2 Module 3 Module 4 Historical Perspectives, Basic Principles of Pharmacovigilance Regulations in Pharmacovigilance in Clinical Research Setting up a Pharmacovigilance Center in Industry Management of Pharmacovigilance Data, Risk Management in Pharmacovigilance, Pharmacoepidemiology Project Total Fees: Rs. 10,000/ Exam and Evaluation: Based upon assignments after each module and Final written exam 7

8 Course Objectives: Post Graduate Diploma in Clinical Research Cosmeceuticals PGDCR Cosmeceuticals is skill development program of 6 months duration with a primary focus on Clinical research and its application in Cosmetics and Dermatology. The course is specially designed to prepare aspirants for a career in clinical research and enhance ability & effectiveness of working professionals already in the field. DCR would help students to get technically sound knowledge with respect to US, Canada, UK, Europe, Indian and Australian regulatory requirements for clinical research. By the end of the course, participants would have: To understand the role and opportunities in clinical research Developed a strong foundation of issues and challenges in clinical research Acquired a strong foundation in the use of various tools used by industries and government in clinical research Gained a high level of confidence working with regulatory bodies of US, UK, Canada, Europe, India Programme Duration: Training program of 6 months duration. Mode of Learning: Distance Learning / E learning ( 1 weak contact programme at Nagpur) Course Contents: Module 1 Introduction to Anatomy, Physiology & Pharmacology Module 2 Introduction to Clinical Research Module 3 Regulatory Affairs and Quality Assurance Module 4 Data Management and Project Management Module 5 Research Procedures in Cosmeceutical and dermatology Module 5 Cosmeceuticals and Dermatology Section A Research Procedures in Cosmeceuticals and Dermatology Section B Regulations in cosmetics and Cosmeceuticals clinical trials Section C Cosmetovigilance 1. Cosmetics and cosmeceuticals 2. Skin and Dermatology 3. Basic Research Methods 4. Research designs in cosmeceuticals 1. Regulatory affairs in cosmetics and Cosmeceuticals clinical trials 2. Global Regulatory requirements 3. Indian perspective 1. Cosmetovigilance & Cosmetic Safety Assessment 2. Cosmetic Toxicology 3. Global Cosmetovigilance schemes Eligibility: B.Sc., B.Tech. M.Tech Cosmetic Sciences B.Pharm, M.Pharm, Ph.D Biotechnology Final year students may also apply Fees: Rs. 10,600/- ( For contact programme an extra amount of Rs. 2500/- will be charged) Exam and Evaluation: Based upon assignments after each module and Final written exam 8

9 About the course: P G Diploma in Clinical Research (PGDCR) - AYUSH The PGDCR-AYUSH course at THE ALCHEMY INSTITUTE is a 6 months online or distance learning course. It focuses on the essential principles of Clinical Research and standard regulatory controls necessary to study the safety and efficacy of AYUSH drugs. The course content has been reviewed and approved by Clinical research experts and academicians where more emphasis is laid on Planning, conducting, monitoring and generating information as per global standards and regulatory requirements. Students are not only trained in Clinical Research but there is a special focus given to Management & Soft Skill learning. It also includes Pharmacovigilance of ASU drugs and various government pharmacovigilance schemes. Duration: 6 months (24 Weeks) Mode of Training: Online & Distance Eligibility: Final year students of AYUSH Interns Graduate or Postgraduate in AYUSH Working Professionals. Contents: Module 1 Module 2 Module 3 Module 4 Module 5 Total Fees: Introduction to Anatomy, Physiology & Pharmacology Introduction to Clinical Research Regulatory Affairs and Quality Assurance Data Management and Project Management Clinical Research Methodologies AYUSH Rs. 9,600 (includes Study material and exam fees) Exam and Evaluation: Based upon assignments after each module and Final written exam 9

10 SCHEME OF EXAMINATION Sr. No. Module Assignment Marks Final Exam Total Marks Passing Marks 1. Module I % 2. Module II % 3. Module III % 4. Module IV % 5. Module V * % 6. Project % *Wherever applicable Assignment & Examination Instructions ASSIGNMENTS 30 marks each FINAL EXAM 100 marks each paper Passing criteria: -Students will have to score at-least 50% marks in each assignment & final paper 1) Assignments will be sent to students by e mails only 2) Student will have to forward either handwritten or computerized printed assignments. Only online students can forward assignments by e mails, in Microsoft Word Format. 3) Write your name, Roll number and subject of the assignments on the first page of each assignment. 4) Write assignment on foolscap or A4 size paper. Leave sufficient margin on each side 5) Each module of assignment should be sent in separate file / folder as they go to different examiners for evaluation. Please try to submit all the modules of 1 set of assignment whenever it is due) 6) Each page of the assignment should be correctly numbered. 7) Retain a duplicate copy of each assignment with you. In case the original assignment is lost in transit or misplaced, you will be required to submit that assignment again. 8) Instructions for Long Questions and short notes: a. Answers should be to the point and crisp b. Please describe only required information 9) Figure to the right indicates full marks 10) Answer all the questions At the end of the course duration Students have to appear for Written Examination. Online students can submit their assignments online by sending attachments at clinicalresearch@alchemyinstitute.in 10

11 ADMISSION PROCEDURE 1. Online Admission a. Go to web site - b. Click on the Courses Tab c. Choose the appropriate course d. Click on the Apply Online tab on the left side on course page e. Fill the online application form completely as directed f. Click on Submit tab at the end of the page 2. Offline Admission a. Go to web site - b. Click on the Courses Tab c. Choose the appropriate course d. Click on the Download Admission Form tab on the left sidebar on course page e. Print the form and Fill the application form completely as directed f. Scan and Send with your scanned copy of Last attempted examination Mark sheet and Passport sized photograph to info@alchemyinstitute.in OR Send the hard copy of filled application along with copy of Last attempted examination Mark sheet and Passport sized photograph to the following address via Post or Courier : To, The Course Coordinator, Alchemy Clinical Research Services 507, C-Wing, Shanti Heights, SBI Building Beltarodi Road, Manish Nagar, Besa At. Po. PIPLA, Nagpur Cell: , info@alchemyinstitute.in Fee Payment Details: For Online Admission: 1. Fill in the mode of payment in the online form 2. Transfer the amount whichever applicable in the A/c (Details of the A/c are given in the form) through Net banking, NEFT or green channel. OR Deposit the amount whichever applicable at the nearest IDBI Bank in the A/c (Details of the A/c are mentioned in the form itself) 3. Call us for confirmation of deposit For Offline Admission: 1. Deposit the amount whichever applicable at the nearest IDBI Bank in the A/c (Details of the A/c are given in the form) through Direct deposit, or NEFT. (Call us for confirmation of deposit) OR Make a D.D. or Cheque of the amount whichever applicable in the name of Alchemy Clinical Research Services payable at Nagpur and send it along with the application form to the same address. 11

12 w w w. a l c h e m y i n s t i t u t e. i n Centers Nagpur - Corporate Office Alchemy Clinical Research Services 507, Shanti heights, Beltarodi Road, Besa, Nagpur 34 Cell: info@alchemyinstitute.in GOA The Alchemy Institute T-6, Vinayaki Bldg. Opp Fire Station, Varkhande, Ponda, Goa Cell: , goa@alchemyinstitute.in