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  1. 1. Advance Certificate Program(s) v-2 Advance Certificate Program(s) in Clinical Research Training Clinical Research Professionals: An Unmet Need 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’. Advance Certificate Program(s) 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. Target Audience • Students from Pharmacy, Medicine and Life-sciences disciplines. • Clinical research professionals employed in Pharmaceutical companies, Contract research organizations (CROs), Research & Academic Institutions etc. • Allied professionals with basic level knowledge on clinical trial processes who aspire to pursue active clinical research stream. • Clinical study coordinators employed at investigator sites. About the Company Catalyst Clinical Services Pvt. Ltd. is a clinical development organization with a prime focus on clinical research training & development activities. With regards to clinical research training it has made pioneering initiatives in terms of, Catalyst Clinical Services Pvt. Ltd. Page 1 of 7
  2. 2. Advance Certificate Program(s) v-2 • Professional Diploma in Clinical Research (PDCR TM ); • ACCR TM • Workshop(s) on Clinical Trials Management; • Oncology Clinical Trials Training; • Training Program for Clinical Investigator & Site Personnel; • Training Program for Ethics Committee Members; • Training Program on 21 CFR Part 11; • Clinical Quest TM ; • Orientation lectures on clinical research etc. More than 2900 personnel (individual & corporate) from 146 cities across 6 countries have participated in various training programs offered by Catalyst Program Director Sanjay Gupta, Director-Clinical Operations with Catalyst Clinical Services Pvt. Ltd has over 10 years of exclusive clinical research experience. He has personally conducted and supervised over 60 clinical trials (Global registration, Phase II CTNRs, IITs etc.) across a wide range of therapeutic areas including oncology, endocrinology, CNS, critical care, andrology etc. He has presented his research work in various International Journals & Conferences including American Society of Clinical Oncology (ASCO), British Journal of Cancer (BJC), British Journal of Radiology (BJR) and Seminars in Oncology etc. He is the network coordinator for a Cancer Research Network setup by University of Oxford, U. K. He has authored 5 books and has been instrumental in taking various clinical research-training initiatives such as, • Chief Editor, Clinical Quest TM • Course Director, Professional Diploma in Clinical Research (PDCR TM ) • Convener, Workshop(s) on Clinical Trials Methodology & Management • Mentor, Orientation lectures on clinical research to various stakeholders (Investigators, ERBs, Students etc.) across the country. Advance Certificate Program(s) Overview Advance Certificate Program(s) consists of multi-disciplinary approach of skills enhancement including Induction, Self-reading, Assignment, Project Work & Award of Credits. Catalyst Clinical Services Pvt. Ltd. Page 2 of 7
  3. 3. Advance Certificate Program(s) v-2 Program Element Duration Mode Description Induction 1 hour Telephone 1:1 interaction between the program director and the participant in order to ascertain the developmental needs, focus area and intensity of training. Self-Reading 80 days Study Material Customized study material holistically covering the program curriculum. Assignment 10 days Paper Based Participant’s perception & opinion on pre- designed case studies. Project Work 60 days Dissertation Dissertation submission on a relevant topic that has been mutually agreed between the participant & the program co-ordinator. Award of Credits 30 days Certification Evaluation of project work by experts, compilation of credits & certification. Catalyst Clinical Services Pvt. Ltd. Page 3 of 7
  4. 4. Advance Certificate Program(s) v-2 Curriculum: Course – 1. Advance Certificate in Clinical Trial Project Management Program Elements: • Introduction to Clinical Research, Guidelines and Standards Governing Clinical Research • Project Milestones Planning & Forecasting • Cost Estimate & Financial Planning • Logistics Planning, Vendor Selection & Management • Clinical Study Process (multi-centric) & Creation of Trial Master File(s) • Management of Regulatory Document Submission • Co-ordination of Individual Site Set-up Activities • Import/ Export Authorization • Organization of Investigator Training Meeting • Study Initiation, Conduct & Milestones Tracking • Audit(s) & Quality Assurance • Study Closeout (trial completion, suspension, termination etc.) Enrolment: Offered throughout the year Program Duration: 6 months Program Fee: Rs. 9600/- Course – 2. Advance Certificate in Clinical Trial Monitoring Program Elements: • Introduction to Clinical Research, Guidelines and Standards Governing Clinical Research • Site Initiation, Review of Essential Trial Documents, Delegation of Duties & Responsibilities at Individual Site • Inventory Planning & Tracking Catalyst Clinical Services Pvt. Ltd. Page 4 of 7
  5. 5. Advance Certificate Program(s) v-2 • Clinical Trial Monitoring • Source Document Verification (SDV) • CRF Review, Collection & Co-ordination of Data Management Activities • Serious Adverse Event (SAE) Review & Regulatory Compliance • Investigational Product Accountability & Management • Escalation, Management & Prevention of Violations/Deviations • Tracking of Enrolments, Payments & Ongoing Correspondence • Site Closure Enrolment: Offered throughout the year Program Duration: 6 months Program Fee: Rs. 9600/- Catalyst Clinical Services Pvt. Ltd. Page 5 of 7
  6. 6. Advance Certificate Program(s) v-2 Course – 3. Advance Certificate in Scientific Writing & Creation of Essential Documents Program Elements: • Introduction to Clinical Research, Guidelines and Standards Governing Clinical Research • Development of Standard Operating Procedures (SOPs) • Protocol • Informed Consent Document (ICD) • Clinical Report Form (CRF) • Data Validation Plan (DVP) • Clinical Study Report (CSR) Enrolment: Offered throughout the year Program Duration: 6 months Program Fee: Rs. 9600/- Eligibility • B.Pharm, M.Pharm, Ph.D • M.B.B.S, M.D, M.S, D.N.B, D.M • B.D.S, M.D.S, B.P.T, B.Tech • B.A.M.S, B.H.M.S, B.U.M.S • B.Sc, M.Sc, Ph.D • Working Professionals with relevant qualifications Third year students are also eligible for enrolment in the program. Candidates are required to send their completed applications along with a Demand Draft of ‘requisite program fee’ drawn in favor of “Catalyst Clinical Services Pvt. Ltd.” payable at Delhi. Evaluation System Advance Certificate Program(s) follows a credit system. Credits would be awarded at two levels: Level Total Credits Minimum Qualifying Credits Catalyst Clinical Services Pvt. Ltd. Page 6 of 7 Candidates can enroll for more than one Program at the same time
  7. 7. Advance Certificate Program(s) v-2 Assignment 60 36 Project Work 40 24 The grading system for overall credits is as follows: ≥ 80 credits 70-79 credits 60-69 credits < 60 credits Excellent Good Satisfactory Unsatisfactory Participants are required to secure minimum qualifying credits at individual level and an overall 60 (and above) cumulative credits for the successful completion of the respective program. Participants unable to secure minimum qualifying credits would be given one more chance to attempt the assignment and/or project work. A fee of Rs.5000/ would be applicable for all reappearing participants. Failure to qualify the repeat chance would require a fresh enrolment (if desired by the participant). Applications completed in all respects should be sent to Program Director: Advance Certificate Program(s), Catalyst Clinical Services Pvt. Ltd., 119, State Bank Colony, G.T. Karnal Road, Delhi – 110 009 (India), Ph: 011-42384005, Telefax: 011-27466248 Email: Catalyst Clinical Services Pvt. Ltd. Page 7 of 7