Advanced Post Graduate Diploma in Clinical Research, Clinical Data Management, Pharmacovigilance & SAS Clinical (Base SAS and Advance SAS) with Live Projects |
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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Oracle Clinical OC/RDC (Optional)
Hands on training will be provided on Oracle Clinical/RDC. Globally most of the Companies representing IT, Pharmaceutical, Biotechnology, SMO and Contract Research Organizations (CRO) have relied on Oracle Clinical to conduct Clinical Trials, making it the market-leading Clinical Research solution providing highly paid Oracle Clinical Jobs in India, USA, UK, as well as other countries.
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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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SAS Clinical (Base SAS and Advance SAS) |
Statistical analysis plays a predominant role in finding the safety and efficacy of a drug in Clinical Research. It has assumed tremendous importance with the advanced research in life sciences. It deals with the theories and methods of collection, analysis and interpretation of data. It plays a major role in Clinical Research because data of Clinical Research are of a variable nature. It is very difficult to draw a concrete conclusion from Clinical Research because of inherent differences between two individuals and also from group to group. The extent of this variability in a character is by way of chance, i.e., biological or normal is revealed by statistical methods. Interpretation, drawing conclusions and recommendations play a major role in Clinical Research. |
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SAS Modules: |
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SAS / BASE |
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SAS / CONNECT |
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SAS / STAT |
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SAS / SQL |
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SAS / REPORT |
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SAS / MACROS |
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SAS / ODS |
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SAS / ETL |
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SAS / GRAPH |
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SAS / ENTERPRISE GUIDE |
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SAS / ACCESS |
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LIVE SAS CLINICAL PROJECT |
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SAS / BASE |
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Introduction to SAS System & Architecture |
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Keep, Drop and Rename Statements |
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SAS Windowing Environment |
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Update Statement |
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SAS Libraries |
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Modify Statement |
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Variables & SAS Syntax Rules |
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Merging Concepts |
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Data Step and Proc Step |
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Interleaving Concept |
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Titles & Footnotes |
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Logical Variables |
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Proc Print Statement |
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Retain Statement |
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Proc Print Options |
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Formats and Informats |
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Set Statement |
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Conditional Statements |
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Dataset Options |
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SAS Functions |
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Options Statement |
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Do Statement |
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Types of Input Statements |
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Randomization |
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Infile Statement With Options |
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BASE SAS PROCEDURES |
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Proc Sort |
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Proc Import |
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Proc Forms |
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Proc Append |
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Proc Export |
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Proc Datasets |
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Proc Transpose |
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Proc Compare |
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Proc Printto |
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Proc Contents |
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Proc Copy |
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Proc Calendar |
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Proc Format |
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Proc Options |
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BIOSTATISTICS |
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Introduction To Biostatistics – Clinical Applications |
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p – Value Interpretation |
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Frequency Distribution Of Clinical data |
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Sampling Variation |
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Clinical Data Presentation |
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Probability Concepts In Clinical Trials |
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Measures Of Centering Constants |
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t-Test – Pharma Applications |
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Measures Of Dispersion |
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Chi Square test – Adverse Event Analysis |
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Normal Distribution |
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Correlation & Regression – Estimation Analysis |
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Null Hypothesis / Alternate Hypothesis |
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ANOVA – Efficacy Analysis |
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SAS / STAT (DATA ANALYSIS) |
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Proc Means (mean, median, std, n, var, cv, range, q, q3, qrange, p50) |
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Proc Glm |
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Proc Univariate |
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Proc Freq |
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Proc Summary |
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Proc Chisq |
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Proc TTest (Paired and Unpaired) |
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Proc Corr |
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Proc Anova (One Way, Two Way and Manova) |
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Proc Reg |
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SAS / GRAPH |
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Proc Plot |
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Proc Gchart |
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Proc Gplot |
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Vertical, Horizontal, Pie |
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Mutliple Plots & Overlay |
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Group, Subgroups |
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Symbol Statement |
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Proc G3D |
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Title and Footnote Statements |
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Proc Gprint |
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Proc Chart |
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Graph-N-Go |
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SAS / REPORT |
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Proc Report |
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Proc Tabulate |
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Column Statements |
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One-Dimensional Tables |
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Break/Rbreak Statements |
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Two-Dimensional Tables |
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Compute Statement |
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Summary Statistics |
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Frequency Procedure |
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Proc Summary |
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SAS / ODS |
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ODS Statements |
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ODS Options |
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Using ODS to Create HTML, PDF, RTF |
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Proc Template |
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Proc Report with ODS |
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SAS / SQL |
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Introduction to SAS/SQL |
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Case Expression and Conditional Logic |
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Proc Sql Statements |
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Sql Set Operators |
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Proc Sql Options |
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Joins in Sql |
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Set Clause |
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Creating ,Populating & Deleting Tables |
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Where Clause |
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Alter Table Statement |
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Order by Clause |
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Renaming A Table & Columns |
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Group by Clause |
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Changing Column's Length |
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Having Clause |
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Aggregate Functions |
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Distinct Clause |
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Pass Through Facility |
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Formatting Output |
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SAS / MACROS |
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Macro Concepts |
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Macro Quoting Functions |
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Macros And Macro Variables |
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Macro Options |
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Creating Macro Variables |
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Macro Expressions |
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Using Macro Variables |
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Macro Character Functions |
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Invoking A Macro |
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Macro Interface Functions |
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Passing Arguments to Macros |
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SAS / ACCESS |
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Import & Export Procedures |
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Proc Access |
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Worksheet Statement |
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SAS / CONNECT |
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Cimport Procedure |
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Cport Procedure |
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Using Select Statement |
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You will be extensively involved in: |
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Clinical Trial Analysis with different Statistical Procedures |
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SAS Programming to find out the efficacy and safety of the drug as per 21 CFR USFDA Guidelines |
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Interpretation of p-value and drawing conclusions |
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Assigning subjects to treatment arms with SAS Randomization Programs |
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Developing SAS programs for statistical analysis and data displays |
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Extensive Programming with the procedures like PROC FREQ, PROC MEANS, PROC SORT, PROC TABULATE, PROC SUMMARY and PROC REPORT |
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Extraction and Migration of data, Multivariate statistical analysis procedures |
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Programming in t-test, Anova, Chi-Square, Regression Analysis, Correlation Analysis…etc. to evaluate the efficacy of the drug |
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Manipulation of SAS datasets using SET, MERGE and Conditional statements |
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Designing and customizing the style, templates and output layout for tables, reports, listings and graphs in PDF, HTML and RTF using ODS features thereby providing greater control on report details such as font, size, data justification, order and label to meet the requirements |
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Generating Reports and Graphs using PROC REPORT, PROC TABULATE, PROC GCHART and PROC GPLOT |
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Creation of SAS datasets from different external files like MS Excel, MS Access, CSV, Tab delimited, Notepad …etc. using Import techniques |
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Data Exporting in file formats like HTML, RTF and PDF using ODS statements |
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Providing Programming support for the creation and maintenance of programs used in Data Management, Data Validation, Data Cleaning and Statistical Report Generation |
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Extensive Applications in SAS/SQL, SAS/ACCESS, SAS/CONNECT and SAS/ETL |
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Writing SAS code to generate Tables, Listings and Figures/Graphs (TLFs or TLGs) including Patient Demography, Adverse Events (AEs), Serious Adverse Events (SAEs) … etc. |
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Defining, Manipulation, Controlling and Reporting/Storage (Query Language) of Clinical Data by using PROC SQL |
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Extensive Programming in writing and debugging the Macro routines and applying Macro variables in SAS program |
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CDISC Domains as per FDA data submission standards |
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Live SAS Clinical Project |
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Learning the skills, knowledge and competencies for the SAS Certification |
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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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