Clinical SAS Course online

Pharmacovigilance Interview Readiness Program (PIRP) duration is 15 days. The total sessions are 15, divided into one hour per day.

Anyone with good knowledge in Pharamacovigilabnce or has undergone Pharamacovigilance training wants to sharpen their interview skills.

The demand for Clinical SAS professionals in Canada is also quite high. SAS is widely used in the clinical research industry in Canada, and many pharmaceutical companies, clinical research organizations (CROs), and biotech firms hire SAS programmers for their clinical trials and research projects. Some of the top companies in Canada that hire Clinical SAS professionals include: IQVIA PPD Parexel Sanofi Roche Novartis GSK Pfizer Janssen Merck In addition to these companies, there are also many smaller CROs and research organizations that hire Clinical SAS programmers. The salary range for Clinical SAS Programmers in Canada varies based on experience, location, and job role, but it is generally competitive. The demand for SAS programmers in Canada is expected to remain strong as the clinical research industry in the country continues to grow. With increasing numbers of clinical trials being conducted in Canada and a growing need for data management and analysis, the demand for Clinical SAS professionals is likely to remain high in the coming years.

Yes, We do have 100% placement Support on successful completion of the course. Each student is entitled to placement assistance. Our placement officer is dedicated to finding a suitable opportunity for each student. We are proud to state within a short duration we have been successful in placing our students in the field of clinical operations as CRCs and process coordinators, as drug safety associates in Pharmacovigilance departments, QA personnel in medical writing departments and as Jr. SAS programmers. Students who have completed a course in clinical research from any other organization may approach us for internship assistance. We cannot guarantee that a company will hire you, as it is based on your performance during an interview. However, we do provide 100% placement assistance. till date, we have 100% Placement record.

The Study Data Tabulation Model (SDTM) is a standard format for organizing and presenting clinical trial data. It is one of the regulatory submission standards specified by the Clinical Data Interchange Standards Consortium (CDISC) and is used for the submission of clinical trial data to regulatory agencies such as the FDA. The SDTM standard defines the structure and content of clinical trial data in a consistent manner, making it easier to analyze and compare data across multiple studies. It provides a framework for organizing data into standard domains, such as demographics, adverse events, laboratory results, and medication data. The SDTM model is intended to be used in conjunction with other CDISC standards, such as the Analysis Data Model (ADaM) for defining analysis datasets used in statistical analysis, and the Define-XML standard for defining the metadata and data structure for submission datasets. Adopting the SDTM standard has many benefits, including reducing the time and cost of data management and analysis, increasing the accuracy and consistency of clinical trial data, and making it easier for regulatory agencies to review and assess clinical trial data. In summary, the Study Data Tabulation Model (SDTM) is a standard format for organizing and presenting clinical trial data in a consistent and standardized manner. It is a key component of the CDISC submission standards for regulatory agencies and has many benefits for clinical trial data management and analysis.

The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) that deals with medical research data linked with healthcare to enable the information system interoperability to improve the clinical research and related areas of healthcare. The CDISC is a global nonprofit organization that actively develops Data standards for the pharmaceutical industry. It sets Data standards, which are a critical component in the quest to improve global public health and overcome the inefficiencies in collecting, processing, and analyzing patient and health-related information. It also drives up on the cost of drug development for life sciences companies and can effectively work on the price and quality of health care delivery for patients and consumers. The CDISC brings efficiency to the entire drug development procedure by improving the Data quality and speed-up the whole drug development process, to perform that CDISC developed a series of standards like Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).

The clinical SAS programmer has the primary responsibility of writing programs in SAS to generate the output (tables, listings, and figures) needed to analyze and report the clinical study data. They have to review the Case Report Forms (CRFs) and the database structures where the data will be stored, written, and collected. A clinical SAS programmer will write SAS programs to clean the database data according to the edit check specifications provided by COMs. Clinical Data clarification items will be generated by this data cleaning system and will be sent to the clinical site for a clear resolution. The clinical programmers writing programs to validate output and data sets produced by others and which entails creating data sets in a standardized structure and format for submission to the FDA

Analysis Data Model (ADaM) is a standard format used for the submission of analysis-ready datasets to regulatory agencies such as the FDA for clinical trials. It is one of the regulatory submission standards specified by the Clinical Data Interchange Standards Consortium (CDISC). The ADaM model is used to organize and structure the data for statistical analysis, and it provides a consistent approach for organizing data across multiple clinical trials. It defines standard variables and formats for the datasets used in statistical analysis, including efficacy and safety data. The Analysis Dataset Model (ADAM) is a subset of the ADaM model, which is used specifically for analysis datasets. It defines the data structure and content for the datasets used in statistical analysis, such as the datasets for primary efficacy analysis, safety analysis, and supportive analysis. The ADAM model is intended to be used in conjunction with other CDISC standards, such as the Study Data Tabulation Model (SDTM) for defining the structure and content of clinical trial data, and the Define-XML standard for defining the metadata and data structure for submission datasets. In summary, the Analysis Dataset Model (ADAM) is a standard format for organizing and structuring the datasets used in statistical analysis for clinical trials. It provides a consistent approach for organizing data and is a key component of the CDISC submission standards for regulatory agencies.

There is no specific eligibility criteria to learn Clinical SAS programming, but a background in life sciences, statistics, or computer science can be helpful. Additionally, familiarity with statistical concepts and programming languages can be advantageous. Life science, Pharmacy, Medical Graduates & Post Graduates (including BDS, BAMS, BHMS, BPT)

Clinical SAS Programmers are responsible for developing and maintaining SAS programs used for clinical data management, statistical analysis, and reporting. They work with large datasets, ensuring data accuracy, integrity, and consistency. The demand for Clinical SAS Programmers in the USA is relatively high, as SAS is a commonly used software tool in the clinical research industry. According to the job market data, there is a consistent demand for Clinical SAS Programmers in the USA. The demand for SAS programmers is expected to grow as the clinical research industry expands. Many pharmaceutical companies, clinical research organizations (CROs), and biotech firms hire SAS programmers for their clinical trials and research projects. Clinical SAS programmers can work in various roles, such as data analysts, statisticians, clinical research associates, and clinical data managers. The salary range for Clinical SAS Programmers varies based on experience, location, and job role, but it can be quite competitive. In summary, the demand for Clinical SAS Programmers in the USA is relatively high due to the widespread use of SAS software in the clinical research industry. SAS programmers play a vital role in clinical trials and research projects, and their skills and expertise are in high demand.

One can start a career as a clinical programmer. The primary responsibility of SAS Programmer is to write programs in to generate the output in the form tables, listings, and figures. which is needed for the analysis and reporting of the clinical study. A clinical SAS Programmer having CDISC (standard specifications for electronically submitted clinical data) expertise would have extensive opportunities.

The demand for Clinical SAS Programmers in India is also quite high, as SAS is widely used in the clinical research industry in India. Many pharmaceutical companies, clinical research organizations (CROs), and biotech firms hire SAS programmers for their clinical trials and research projects. There are several companies in India that hire Clinical SAS professionals. Some of the top companies in this field include: TCS (Tata Consultancy Services) IQVIA Cognizant Wipro Accenture Infosys Quintiles Novartis Parexel Icon Clinical Research In addition to these companies, there are also many smaller CROs and research organizations that hire Clinical SAS programmers. The salary range for Clinical SAS Programmers in India varies based on experience, location, and job role, but it is generally competitive. The demand for SAS programmers in India is expected to grow as the clinical research industry in the country continues to expand. With increasing numbers of clinical trials being conducted in India and a growing need for data management and analysis, the demand for Clinical SAS Programmers is likely to remain strong in the coming years.

Yes, it’s definitely possible to learn Clinical SAS programming along with a clinical research course. In fact, many clinical research courses include instruction on SAS programming, as it’s a commonly used tool for Data management and analysis in clinical research. SAS (Statistical Analysis System) is a powerful software suite used for data management, statistical analysis, and reporting in a variety of industries, including clinical research. Learning SAS programming can be an asset in the field of clinical research, as it allows you to work with large datasets, perform statistical analysis, and generate reports. Suppose you’re interested in learning Clinical SAS programming. In that case, you may want to look for a clinical research course that includes instruction on SAS or considers taking a separate SAS programming course. We provide a PG Diploma in Clinical Research course, including Clinical SAS Programming. In summary, learning Clinical SAS programming alongside a clinical research course can be a valuable skill set in the industry.

The Clinical SAS Course online duration is three months .

eLearning is a fantastic way of learning any course. Because of the high-speed internet connection video conferencing and Instructor-led online Classes are gaining popularity. Instructor-led Online Clinical Research Training (e-learning) can be the most convenient medium of learning from any part of the world. BCRI Conducts Online Clinical Research classes, using online software like zoom.us, WebEx, and gototraining. All these software provide a live instructor-led training classroom environment where instructors and attendees can join the class from any part of the world that, too, without spending time on travel. This is a highly advanced system where instructors and attendees can share their screen, two-way audio meetings, and also whiteboards for online classes. The feature of online clinical research Courses is class recordings. We share the recording of your class for life access. All Clinical Research online sessions are recorded and will be shared with the attendees at the end of the meeting, so you can revise the course anytime. Learn Clinical Research Online with us. Clinical Research online classes in Bangalore Clinical Research online classes in Chennai Clinical Research online classes in Delhi Clinical Research online classes in Kolkata Clinical Research online classes in London Clinical Research online classes in Chicago Clinical Research online classes in San Francisco Clinical Research online classes in Dallas Clinical Research online classes in Washington Clinical Research online classes in New York Clinical Research online classes in Boston Clinical Research online classes in Singapore

This opportunity is open to graduates and postgraduates with a background in life sciences, pharmacy, and medicine (including dentistry, Ayurveda, homoeopathy, and physiotherapy).

Upon successfully completing the course and assessments, participants typically receive a certificate that can showcase their acquired knowledge and skills.

Enrolling in online Clinical Research Courses can boost your knowledge and skills, which can give you an edge in the clinical research industry. This may also provide you with potential career prospects.

In order to register for a course, it is typically necessary to visit the website of the BCRI and navigate to the page for the desired course. From there, one can find all the necessary information, select the course they wish to take, and then follow the provided instructions for registration.

The Clintech provides an interactive training platform that includes discussion forums, live sessions, and virtual class groups. This allows learners to interact with instructors and engage in discussions with fellow students.

There are Different Course Duration Based in Courses. Online PG Diploma in Clinical Research (all Inclusive) : 7.5 Months Advanced Diploma in Clinical Research (CR, CDM, PV): 4 Months Online Certification course in Clinical Research & Clinical Data Management: 2 Months Online Certification Course in Pharmacovigilance: 2 Months Online Advanced Certification in Regulatory Affairs : 3 Months SAS Online Training on Clinical Trial Data Analysis : 3 months

Candidates interested in learning Hands-on MedDRA Coding and Dictionary Candidates who have either completed or pursuing a Pharmacovigilance course. Candidates interested in joining the MedDRA Coding team. Candidates interested in joining ICSR, Aggregate, Literature search, or Signal team. Candidates interested to learn practical aspects of MedDRA and handling the dictionary. Candidates interested in taking the MedDRA Exam from MSSO. Candidates who are working in any other medical or life science domain and willing to shift to PV.

Life Science, Pharmacy, health care, or Medical Graduates. Basic knowledge of coding requirements Basic knowledge of pharmacovigilance Comfortable in learning a new database.

Overview of Pharmacovigilance – Importance of safety monitoring Overview of all Pharmacovigilance Regulations Regulatory guidelines and laws governing Pharmacovigilance across Globe

Industry method of Regulatory site screening and searches Identification of safety reports Identification of safety updates and changes Identification of labelling changes Extended EudraVigilance medicinal product dictionary Company Core Data Sheet Preparation

Regulatory Requirements in the USA – FDA Perspective. What, When, How to Report, Submission Methods Regulatory Requirements in Europe – EMA Perspective and Regulation. What, When, How to Report, Submission Methods The regulatory system in India (National Pharmacovigilance Program and centers) What, When, How to Report, Submission Methods

Candidates who are interested in the Regulatory domain of Pharmacovigilance, including freshers and experienced candidates. Regulatory Affairs Course is an advanced course for any life science graduate who wants to enter the regulatory domain, including both freshers and experienced candidates.

The course duration is one month In- class. 20 Session of 1 hour Each

The course requires candidates to be familiar with clinical trial fundamentals. There will be a brief discussion in class about Pharmacovigilance. Recommend Course: Certification in Pharmacovigilance & Basics of Regulatory Affairs.

The course is designed for aspiring Clinical Research Associates and Clinical Research Coordinators (it is also appropriate for new CRAs and CRCs with less than six months of experience). People who are interested in careers in pharmaceuticals and clinical research can take this course. Those in college or just graduated with a degree in science Nurses

Yes, we provide online clinical research courses for international students in countries like USA, Canada, and Australia. These courses are readily available over the internet, allowing students to access them in their own time and from the comfort of their homes.

The Clinical Research Associate (CRA) Training Program is designed to prepare you for the responsibilities of a clinical research professional. Through a series of interactive Sessions, each participant will gain knowledge and skills in the following areas: how to effectively communicate with prospective participants and investigators, how to develop study designs, gather and analyze data, design appropriate ethics statements for studies and evaluate data when needed.

The course duration is one month In- class. 20 Session of 1 hour Each

Yes, We do have 100% placement Support on successful completion of the course. Each student is entitled to placement assistance. Our placement officer is dedicated to finding a suitable opportunity for each student. We are proud to state within a short duration we have been successful in placing our students in the field of clinical operations as CRCs and process coordinators, as drug safety associates in Pharmacovigilance departments, QA personnel in medical writing departments and as Jr. SAS programmers. Students who have completed a course in clinical research from any other organization may approach us for internship assistance. We cannot guarantee that a company will hire you, as it is based on your performance during an interview. However, we do provide 100% placement assistance. till date, we have 100% Placement record.

The course duration is 1.5 months.

Pharmacovigilance (PV) is the Science & Activities related to the Detection, Assessment, Understanding & Prevention of adverse effects or medicine related to any problem as defined by the World Health Organization. It is an important function with the primary goal to ensure the safety of patients with the use of pharmaceuticals, including biologics, such as vaccines, plasma-derived therapies, and/or medical devices.

Life science, Pharmacy, Medical Graduates & Post Graduates (including BDS, BAMS, BHMS, BPT)

As Life Science Graduates, one can have good opportunities in Research & Development Wet & dry Labs, but not all get such opportunities. Enhancing your skills to work in a CRO will be the right choice. you can Join Courses Like PG Diploma in Clinical Research, Clinical Data Management,Pharmacovigilance, Medical Writing, Medical Coding, Clinical Data Analysis, etc,

Yes, the internship will be provided at the end of the course for a period of two months. We believe that by performing an activity, internship enhance your existing theoretical knowledge and improves your skills.

The course duration is 6 months In- class sessions = 6 months & Internship = 2 months(Optional).

Life science, Pharmacy, Medical Graduates & Post Graduates (including BDS, BAMS, BHMS, BPT)

As Life Science Graduates, one can have good opportunities in Research & Development Wet & dry Labs, but not all get such opportunities. Enhancing your skills to work in a CRO will be the right choice. you can Join Courses Like PG Diploma in Clinical Research, Clinical Data Management,Pharmacovigilance, Medical Writing, Medical Coding, Clinical Data Analysis, etc,

Yes, We do have 100% placement Support on successful completion of the course. Each student is entitled to placement assistance. Our placement officer is dedicated to finding a suitable opportunity for each student. We are proud to state within a short duration we have been successful in placing our students in the field of clinical operations as CRCs and process coordinators, as drug safety associates in Pharmacovigilance departments, QA personnel in medical writing departments and as Jr. SAS programmers. Students who have completed a course in clinical research from any other organization may approach us for internship assistance. We cannot guarantee that a company will hire you, as it is based on your performance during an interview. However, we do provide 100% placement assistance. till date, we have 100% Placement record.

Process flow Data management plan Study set up Tracking CRF Data Entering data Managing lab data Identifying and Managing discrepancies Collecting adverse Event Data CDM systems Where systems come from? Choosing vendor products Implementing New Systems System Validation Test plans Migrating legacy Data Change control Study Set-up Approved Protocol Project Plan eCRF Specification Visit Form Matrix DB design DVS UAT IxRS Integration Final Sign off – Go Live DMP Creating standards Creating hierarchies Sops and guidelines Working with CROS CRF Design Consideration Remote Data Entry Data entry in RDC and Discrepancy Management in RDC Auto coder Algorithms Clinical Trail Management Fundamentals of clinical trials Basic statistics for clinical trials Clinical trials in practice Reporting and reviewing clinical trials Protocol development Trial designs Project management and research co-ordination Regulatory affairs, good clinical practice and ethics Data management Data monitoring and interim analyses Data reconciliation DCMs and DCIs Study Conduct Tracking CRF Data Creating, Data Collection Modules and layouts corresponding to CRFs to allow for data entry Entering data, Generating and Testing data entry screens and validate the range, format, date, missing fields Data validation User acceptance testing (UAT) Managing lab data Identifying and Managing discrepancies Collecting AE Data SAE Reconciliation Reviewing clinical data as per SOP, protocol, and study specific guidelines Medical Coding IxRS Reconciliation Listing Reviews, consistency checks QC Status Reports All Subjects completed final visits/f-up visits Medical Coding data review completed and issues resolved Final SAE reconciliation All queries resolved and DB updated Final review completed All expected forms and visits are locked/frozen QC steps conducted and QC plan and report documented QA issues addressed if any All documentation completed as per DMP and stored according to SOP Data is archived/submitted

Introduction to Global Regulatory Authorities for pharma and healthcare industries Regulatory affairs in clinical research WHO –UMC (Uppsala Monitoring Committee), CIOMS Drug Development Process, Clinical Trials and related norms and regulations European Pharmacovigilance System FDA Good Clinical Practice (GCP) ICH Good Clinical Practice (ICH-GCP) guidelines clinical trials International Council for Harmonisation GCP in pharma, Main GCP principles, GCP compliance GMP and other good practices. Institutional review board(IRB) / independent ethics committee (IEC) Quality Assurance and Drug Regulations, ICH and WHO guidelines Technical Requirements for Pharmaceuticals for Human Use Data monitoring committees European Forum for Good Clinical Practice(EFGCP),European Medicines Agency (EMEA) Dossier preparation in CTD format, eCTD submissions Healthcare Industry IPR, Patents, copyrights and Trademarks Pharma and Healthcare products- Marketing, Import and Export regulations Compliance guidelines, Govt. Audits (FDA, MHRA, PMDA, TGA, DCG, etc) and Breach reports Indian GMP Regulations Download Course Curriculam

Phases of clinical trials How many phases of clinical studies are there A phase 0 study and Phase 5 clinical trial Difference between clinical trial and clinical research Clinical Research vs. Medical Care What Is a Clinical Study? Clinical Trials Observational Studies Conduction of Clinical Studies Site for Clinical Studies and duration and Reasons for Conducting Clinical Studies Participating in Clinical Studies and Who Can Participate in a Clinical Study? Participants Protection and Considerations for Participation Relationship to Usual Health Care Active control studies Phases of FDA approval Percentage of drugs fail clinical trials Microdosing Dose Ranging Single ascending dose (Phase Ia) Multiple ascending dose (Phase Ib) Trial design Efficacy vs Effectiveness Investigational new drug and New drug application

Introduction of Drug Discovery and Development Discovery and Development Preclinical Research Clinical Research Drug Review Post Market Drug Safety Monitoring Introduction to Pharmacovigilance Pharmacovigilance (WHO Definition) History of Pharmacovigilance Scope and purposes of Pharmacovigilance Basic Concepts: Terms and definitions General idea of PV and types of AE reporting Types and sources of data The process of Pharmacovigilance- Signal Detection and Drug recall What are safety signals? Pharmacovigilance Reporting Database Risk Assessments & Evaluation Reporting Criteria to Health authorities and timelines Quality System In PV Expedited Reporting Criteria PSUR & PBRER Different reporting formats used in PV PSUR and DSUR overview PV Database and Signal Detection Safety ignals Signal Management Risk Assessments & Managements PV Database Index Case receipt Data verification and validity check Triage Duplicate search Book in and registration Data Entry Coding of AE and Drugs Causality assessment Expectedness assessment Why causality assessment WHO –UMC causality assessment system Case Narrative Quality check Reporting or Submission Deletion and nullification Initial Receipt date and Day 0 Importance Case linking, Mother and Baby cases Special Case Scenarios: LOE, Off-Label use, Misuse, Overdose, Pregnancy & Medication Error Practicing Real Time cases scenarios Drug Dictionaries, ADR dictionaries and Coding of the events WHO drug dictionary COSTART MedDRA ADR classification SAE and Seriousness criteria Narrative Writing Overview and Characteristics Case Narrative Sections of Case Narrative Steps and Construction of a narrative

Any graduates /Post Graduates in medical, paramedical, and Life Science graduates. Like, BDS, BAMS, BHMS, M.Sc, B. Sc in (Biotechnology, Microbiology, Biochemistry, Zoology, Botany, Bio-informatics), BPT, MPT, BOT, MOT any other medical field graduates.

Medical Coding is converting the text information related to healthcare services into alphanumeric codes using ICD and CPT software. I.e., we should code the patient’s medical reports using the ICD and CPT software. The medical reports have to find the codes for the disease conditions using the ICD-10cm (International Classification of Diseases, 10th revision, Clinical Modification). The respective procedures have to find the procedural codes from CPT (Current Procedures Terminology) Software.

The courses are specifically designed to prepare students for International Certification exams (i.e., AAPC & AHIMA), even though certification is not required as a prerequisite by all employers. The exams most commonly taken directly after Completing the Medical Coding Course are the Certified Professional Coder (CPC) exam offered by the American Academy of Professional Coders (AAPC) and the Certified Coding Associate (CCA) exam offered by the American Health Information Management Association (AHIMA).

Yes, We do have 100% placement Support for successful completion of the course. Each student is entitled to placement assistance. Our placement officer is dedicated to finding a suitable opportunity for each student. We are proud to state within a short duration we have been successful in placing our students in the field of clinical operations as CRCs and process coordinators, as drug safety associates in Pharmacovigilance departments, as QA personnel in medical writing departments, and as Jr. SAS programmers. Students who have completed a course in clinical research from any other organization may approach us for internship assistance. We cannot guarantee that a company will hire you, as it is based on your performance during an interview. However, we do provide 100% placement assistance.

After completing a Medical Coding course, you can start your career as a trainee coder; subsequently, you can grow your career as a senior coder, Quality Analyst in Coding, Team Lead, Process Lead, Manager, Assistant Manager & so on.