Clinical Research and Clical Trial Module 1
Pharmacovigilance Module 2
Clinical data Management Module 3
Medical Writing Module 4
Pharmacovigilance
Skillbee Solution is India’s leading Pharmacovigilance Course Training Institute based in Hyderabad, Bangalore, Pune and Mumbai. Those who are seeking a role in drug safety or pharmacovigilance should hold a life sciences, pharmacy or medical degree. Pharmacovigilance is an inseparable part of ever growing and recession proof CR industry. Only professionally trained employees get to make their mark and reach pinnacles of success in this fast moving sector of the health care industry. Thus Company Connect Consultancy targets to teach, train and polish aspirants as Pharmacovigilance professionals with clear understanding and complete knowledge of the industry and its working.
The Industry Certificate Programme in Pharmacovigilance aims to benefit the professionals working in the various CR industries as it is structured by experts from the industry themselves and so global coverage and understanding of the industry and its functional areas is promised.
This course covers a variety of important aspects of the career, including reporting, report writing, signal detection and risk management, as well as providing a thorough understanding of the regulatory bodies around the world.
For anyone looking to find a job in pharmacovigilance or drug safety, previous experience in the industry is of great value. Alternatively, a clinical background and first-hand experience with adverse reactions can be advantageous so nurses and pharmacists can also be attractive candidates.
A career in drug safety and pharmacovigilance will generally start with a position as a drug safety associate, officer, scientist or coordinator. Responsibilities will then progress to senior specialist or management roles, often with an in-depth knowledge of a specialty area, such as medical writing, auditing, medical affairs or quality assurance.
Finding a pharmacovigilance job or drug safety position abroad can also be a great opportunity for those seeking a career in this sector and opportunities are prevalent, although generally in the larger companies.
Remuneration for a position in drug safety and pharmacovigilance can vary greatly, with factors including the company, the location, the candidate’s experience and the requirements of the role.
What jobs are available in drug safety and pharmacovigilance?
Jobs in drug safety and pharmacovigilance exist in both permanent and contract arrangements. Temporary agreements can last from three to 12 months, with many of these positions being for drug safety medical writers or interim pharmacovigilance physicians.
Drug safety associates and officers monitor and track adverse events and reactions, as well as other medically related product information.
Senior pharmacovigilance consultants process adverse event reports sourced from various studies. The information that is gathered is then submitted to the regulatory authorities.
Drug safety managers and directors organise the processing and reporting on drug safety reports and review trial-related documents in order to monitor the drug safety profile of specific products. Responsible for medical case reviews and assessing product safety in clinical trials, drug safety physicians work to assess and obtain information about the safety of products.
Clinical Research
Skillbee Solution is offering an opportunity to get certified and become a certified GCP Professional. To enable the participant, clear the qualifying exam for obtaining the certification, the institute will be offering proper training materials which will be provided without any extra cost save for the cost for applying for the Certification Examination. This certification is aimed at improving the conceptual knowledge of the participant for Good Clinical Practices and resolving any dilemmas that a working professional may face regarding the application of GCP guidelines at his workplace. Successful performance in this exam implies that the participant has in-depth knowledge and clear understanding of industry guidelines and regulations. The study material has been carefully designed to introduce the attendee to various aspects and basics of GCP, its need and benefits in assuring the ethical and scientific integrity of clinical trials. GCP compliance provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. Several specialized topics have been added to guide the participant through ICH GCP regulations, compliance needs, comparison of Indian GCP guidelines vs. ICH GCP guidelines etc.
The case study based approach in the training provided for the certification programme is designed for working professionals in full time employment who want to update their knowledge and gain required skills and attitude in the area in order to become a certified GCP professional in the domain. This certification is also beneficial for professionals from different streams to help them intensify their knowledge. An advanced training having rigorous case studies based methodology will be imparted to all participants for preparing for the Certifying Examination.
What is Clinical Research?
Clinical research is a branch of healthcare science which includes detailed study of human health and study. It
focuses to advance medical knowledge by studying candidates through direct interaction or through the collection and analysis of blood, cell, tissues or some other samples.
Scope of Clinical Research
Clinical Research determines the safety and effectiveness of medicines, equipment, and diagnostic products etc prior to release in the market. Sometimes, people get confused between clinical research and clinical practice. The difference is, one is to collect evidence to establish a treatment, while lateral is used to establish treatments itself. Clinical research is referred to the complete bibliography of a drug, device or a biological test. There is a huge requirements in Clinical Research in India.
Clinical Research Professional Courses
Skillbee Solution is one of the well known Clinical Research training and placement firm which aims high quality Job oriented training and placements. Clinical Research is an interesting career option with a great scope for professional career. We are comprises of highly qualified, dedicated and experienced faculty working
with the vision to provide best quality job oriented training to the candidates. The clinical trials market worldwide is worth over USD 26 billion and the industry has employed an estimated 2,10,000 people in the US & over
70,000 in the UK, and that form one-third of the total research and development staff. There are more than 2, 50,000 positions vacant globally & salaries vary in the region of approximately USD 40,000 per annum for a Clinical
Research Coordinator. A career in Clinical Research offers excellent job opportunities in USA, Europe (UK), Singapore & India. India is going to be the major hub of clinical trials.
Clinical Research Modules to be covered:
Module -1 : Clinical research
Module -2 : Clinical Data Management
Module -3 : Pharmacovigilance
Module -4 : Medical Writing
Career Opportunities in Clinical Research
Let’s explore the jobs in clinical research for freshers right from the entry-level to the managerial level. When you are a fresher in this field it is very important that you have a clinical research certification in your hand. This opens up multiple opportunities for you. There are multiple and exciting jobs available in Clinical research some of them are mentioned below:
Clinical Research Associate
Clinical Research Coordinator
Clinical Research Investigator
Clinical Research Manager
Medical Writer
Clinical Data Manager
Clinical Trial Auditor
Project Manager
Advanced Certified Program In Clinical Research & Operations Management
The pharmaceutical and biotech industry is experiencing a change worldwide with more impetus on innovation and personalized medicine. The business models are maturing to the next level of niche busters and towards a coexistence of novel and the age old blockbuster strategies.
With the economic drift and emerging economies like India, China, Brazil and Russia, the pharmaceutical and biotech industry is shifting research and development towards these regions especially in the phases of clinical development. Further, indigenous pharmaceutical and biotech companies in these regions are increasing their R&D efforts both for innovative molecules as well as the generic market.
Consequent to this scenario, a large number of clinical research organizations have recently developed which include a range of full service CROs, early phase CROs, SMOs, companies with selective specialized services like data management, clinical research consultancies, KPOs etc. This has created a demand for skilled workforce in the clinical research industry.
This course will provide extensive training in the niche domain of clinical research. It incorporates end-to-end theoretical & practical training.
Certified Study Resources for Professionals
- Introduction to Clinical Research Industry and Basics of Clinical Trials
- Drug Discovery & Development Process
- Pre-clinical studies Pre-clinical studies
- Basics of Clinical Trials & Clinical Research
- Terminology & Definitions in Clinical Trials
- Ethics and Ethical Guidelines for Clinical Trials and Good Clinical Practice (GCP): ICH Good Clinical Practice E6 (R2)
- Indian GCP and Schedule Y
- Types and Phases of Clinical Trials
- BA/BE Studies
- Regulations Guiding the Clinical Research Industry- History and Basics of National and International Regulatory Bodies
- Research Methodology & Clinical Trial Design
- Essential Documents in Clinical Trials: Protocol, CRF, Inform Consent, Investigator’s Brochure, Study Progress Report
- Responsibilities of Clinical Research Professionals
- 21 CFR PART 11
- Clinical Data Management
- Pharmacovigilance in India, US & UK
- Medical Coding (MedDRA & WhoDrug)
- Medical Writing
- Informed Consent Document
- Clinical Trials -Latest updates : New Drugs and Clinical Trials Rules, 2019
- Intellectual property Rights (IPR) and Patent Laws
- Industry Based Case Studies
Clinical data management
Skillbee Solution offers top quality courses in clinical research, Clinical Data Management and Data Analysis with strong emphasis on practical training and projects.
Skillbee Solution aim to provide an efficient integration of academic knowledge and industry oriented expertise. We ensure to provide assistance for freshers to enter into the clinical research Industry , as well to the professionals who wish to achieve excellence at their professional world.
All clinical research and clinical data management courses offered by Skillbee Solution are top quality and job oriented . The certificate Program in Clinical Research and Clinical Data Management and SAS provide students more opportunity to build a successful career In Clinical Research, CDM and SAS industry .
We help the students to prepare their CV.
Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that helps maintain the quality standards of CDM processes. Various procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial. In the present scenario, there is an increased demand to improve the CDM standards to meet the regulatory requirements and stay ahead of the competition by means of faster commercialization of product. With the implementation of regulatory compliant data management tools, CDM team can meet these demands. Additionally, it is becoming mandatory for companies to submit the data electronically. CDM professionals should meet appropriate expectations and set standards for data quality and also have a drive to adapt to the rapidly changing technology. This article highlights the processes involved and provides the reader an overview of the tools and standards adopted as well as the roles and responsibilities in Clinical Data Management.
Module 1.Clinical Trail Process and Design
Module 2.ICH-GCP and GCDMP
Module 3.Clinical Data Management Systems
CRF Design
Data Entry & Data Collection
Data Load/Transfer
Data Storage
Data Validation
Data Export (SDTM)
Query Management
Data Archiving
Quality Systems, SOPs and Audits
Safety Management and Pharmacovigilance
Data Management Systems and Tools
Medical Coding and Medical Dictionaries
CDMS, AERS,EDC,OCTMS
Documentation and Document Management System
Module 4.Statistical Analysis (analytical Tools) and Reporting
Module 5.Project Management
Module 6.Security Systems
Practical Training will be also provided on Oracle Argus Safety Database on the following topics:
Case processing
MeDRA coding & WHO DD coding
Duplicate Check and case initiation
SAE Narrative writing
Benefits of Course from Skillbee Solution.
Complete Course Material will be provided including detailed information about the entire work flow of Drug Safety Associate.
2 months internship available after rigorous training in Pharmacovigilance including CDM
Own CRO live Projects
We Provide Real Time Experience on Global Drug Safety Software with PSUR & DSUR Training.
Highest Placement record across all training institutes
Industry based SOP’s training
Trainers with minimum of 7+ years of experience
Comprehensive teaching by Medical Doctors
Hands on experience on Global Safety Databases used in the Industry.
Total 150 hours of exposure to theory, case studies and practical’s.
Practical Hands on Training will be provided on Case Processing, Narrative Writing, MedDRA 16.1 & Who DRUG Coding.
Medical Writing Course
SkillBee Solution offers top quality courses in clinical research, Clinical Data Management and Data Analysis with strong emphasis on practical training and projects. SkillBee Solution aim to provide an efficient integration of academic knowledge and industry oriented expertise. We ensure to provide assistance for freshers to enter into the clinical research Industry , as well to the professionals who wish to achieve excellence at their professional world. All clinical research and clinical data management courses offered by SkillBee Solution are top quality and job oriented . The certificate Program in Clinical Research and Clinical Data Management and SAS provide students more opportunity to build a successful career In Clinical Research, CDM and SAS industry .We help the students to prepare their CV.
Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that helps maintain the quality standards of CDM processes. Various procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial. In the present scenario, there is an increased demand to improve the CDM standards to meet the regulatory requirements and stay ahead of the competition by means of faster commercialization of product. With the implementation of regulatory compliant data management tools, CDM team can meet these demands. Additionally, it is becoming mandatory for companies to submit the data electronically. CDM professionals should meet appropriate expectations and set standards for data quality and also have a drive to adapt to the rapidly changing technology. This article highlights the processes involved and provides the reader an overview of the tools and standards adopted as well as the roles and responsibilities in CDM.