Clinical Research, Pharma Research, Pharmacovigilance & Clinical Data Management - CDM |
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- MBBS, MD,BDS, BHMS, BUMS, BAMS, BPT
- M.Sc. , (Microbiology/ Biochemistry/ Biotechnology/ Bio-informatics/ Chemistry/ Genetics/ Botany/ Zoology/ Life Sciences/ Nursing)
- B.Pharmacy, M.Pharmacy, B.Tech.(Biotechnology)
Clinical Research
A new blockbuster drug takes around $850 million to be developed by an international giant. Nearly 70% of which goes towards clinical trials. In the area of clinical trials, India, with its vast and diverse, disease patient population, is now showing competence at nearly a third for the costs compare to the west.
The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, or other interventions to patients in strictly scientifically controlled settings, and are required for regulatory authority (in the USA, the Food and Drug Administration) approval of new therapies. Trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions. The trial objectives and design are usually documented in a Clinical trial protocol.
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Pharmacovigilance
Pharmacovigilance is a discipline which is concerned with identifying, validating, quantifying, evaluating and minimizing the adverse effects of medicine thereby increasing the safety of drugs in use. It is a study of drug related adverse effect carried out by pharmaceutical industries to suggest warnings and recommendation for product withdrawal.
Pharmacovigilance plays an important role in the use of medicines by providing information about ADRs in the general population. Knowledge of the adverse effects of drugs is important for effective treatment. Communicating the potential harm of drug-use to patients is a matter of high priority and should be carried out by every prescriber. Information collected during the pre-marketing phase of drug development may not detect rare ADRs. The use of a drug during a clinical trial is under controlled conditions. Clinical trials generally enroll a selected, limited number of patients and may not include certain sections of the population. Drug use in special situations or drug interactions may not be studied. Therefore, the post-marketing surveillance of drugs is important. The use of traditional and complementary drugs (e.g. herbal remedies) may also pose specific toxicological problems, when used alone or in combination with other drugs. Therefore, Pharmacovigilance is needed for detecting ADRs and specifically to combat counterfeit and substandard quality products. ADR monitoring ensures that patients obtain safe and efficacious products. Pharmacovigilance plays an important role in ensuring drug safety.
Pharamcovigilance improves patient care and safety in relation to the use of medicines and all medical and paramedical interventions. It also contributes to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging safety and more effective use.
CDM - Clinical Data Management
CDM (Clinical Data Management) is used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report forms are stored in CDMS. CDM (Clinical Data Management) comprises of designing and deploying clinical study as well as collecting data and managing data for that clinical study. Electronic Processes are used to plan, collect, access, exchange, manage and archive data for the purpose of reporting the entire clinical study data. Adoption of CDM to drive forward drug research is gaining pace, championed by the pharmaceutical industry, primary health providers, CRO industry & USFDA regulators. |
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Course Curriculum |
Clinical Research |
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Introduction to Clinical Research |
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IRB / IEC |
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Pharma Research/Drug Development Process |
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Informed Consent Process |
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Pre-Clinical Research |
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Roles and Responsibilities of Clinical Trial Team |
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Clinical Trial Phases (I - IV) |
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Site Initiation Study |
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IND/NDA/ANDA |
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CRF & e-CRF |
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Ethics in Clinical Research |
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Standard Operating Procedures (SOPs) |
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ICH-GCP Guidelines |
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Investigator Brochure (IB) |
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Regulatory Affairs |
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Protocol Design and Format |
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US FDA Guidelines |
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Investigational Product (IP) |
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DCGI/Schedule Y |
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Essential Documents for a Clinical Trial |
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EMA |
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Submission & Publication of Clinical Study Report |
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CRO Industry |
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Audits & Inspections |
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Pharmacovigilance |
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Introduction to Pharmacovigilance |
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Management of Safety Signals |
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Good Pharmacovigilance Practices |
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Indian Scenario |
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Pharmacovigilance Plan (ICH E2E) |
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Risk Management Process |
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Classification & Reporting of ADRs |
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Risk MAPs |
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Periodic Safety Update Reports (PSURs) for Marketed Drugs (ICH E2C) |
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Pharmacoepidemiological Studies |
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Safety Signal Detection |
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Registers |
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Safety Signal Assessment |
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Surveys |
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Reporting of Safety Signals |
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Clinical Data Management |
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Introduction to Clinical Data Management |
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Query Management |
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Guidelines for CDM |
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Data Clarification Form (DCF) |
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Roles and Responsibilities of CDM Team |
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Database Closure and Freezing |
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21 CFR Part 11 |
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Data Storage & Archival |
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CRF Designing |
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Data Coding and Medical Dictionaries |
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Data Capture Methods |
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Safety Data Management (AEs/SAEs) |
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Data Entry |
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SAE Reconciliation |
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External Data Loading |
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Quality Assurance & Quality Control |
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Data Validation Procedures |
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Auditing |
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Data Cleaning |
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CDISC Standards |
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Discrepancy Management |
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Live Project |
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Clinical Data Management System |
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Data Entry |
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Protocol Designing |
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Data Validation |
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CRF Designing |
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Discrepancy Management |
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CRF Tracking |
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Query Management |
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Study Event Creation |
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Database Locking |
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Groups Creation |
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Data Security and Data Privacy |
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You will be extensively involved in: |
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Learning the skills, knowledge and competencies of a candidate for the jobs in CDM, Clinical Research and Pharmacovigilance |
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Becoming more familiar with roles/jobs as a part of the study team |
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Understanding the Concepts of US FDA Regulatory Affairs in the field of Pharmaceuticals, Clinical Research, CDM & Pharmacovigilance |
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Reviewing the study related essential documents in compliance with ICH GCP Guidelines |
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Understanding the Ethics Committee Guidelines, which safeguards the rights, safety and well-being of trial subjects |
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Methodology of writing Trial Protocols |
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Understanding the Informed Consent Form and the Informed Consent Process |
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Management of Trial Master File (TMF) |
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Understanding the Pharmacovigilance Concepts and Good Pharmacovigilance Practices |
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AE/SAE Reporting |
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Maintenance of ADR Reporting Forms, PSURs |
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Understanding the Concepts of Risk Management Process and Safety Signal Detection |
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Understanding the Pharmacovigilance Plan (ICH E2E) |
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Designing of Case Report Forms (CRFs) |
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Understanding the Electronic Records & Electronic Signatures |
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Data Capture, Loading from External files, Editing, Storage and Archiving the Clinical data |
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Verification of e-CRFs |
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Discrepancy Management and Query Resolution |
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Learning the CDISC Standards (SDTM, ADaM, LAB, ODM) |
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Our Students are Alumni of |
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We also Offer |
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 Training with Project Experience
Certification |
Live Projects for Final
Semester Students |
Live Projects for Summer
Training Students |
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Corporate Training |
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Placement Guidance |
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