Clinical Data Management Courses & Training Online
Skillbee Solution is India’s leading Clinical Data Management Course and Training Institute based in Bangalore, Hyderabad, Pune and Mumbai. Those who are seeking a role in drug safety or pharmacovigilance should hold a life sciences, pharmacy or medical degree.
Clinical Data Management Professional
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 Codings 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.
Eligibility
Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.
Upon Successful completion of Course our team will provide Following
Resume Preparation
Interview Preparation and Mock Interview Session.
Communication skills and personality development sessions
Placement Assistance
Course Registration
The registration will be carried out by contacting on Skillbee Solution. How To Apply
Program Deliverables
A comprehensive study material for all the modules in Soft copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.
Assignments for all the programme modules for continuous evaluation and guidance.
Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
Online classes for all the modules will be conducted on the weekdays or Weekend (as per batch you choose). Moreover, a doubt clearing session will also be scheduled before the examination.
All the efforts are made by faculty members to make the entire programme modules easily understandable.
Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
All learning and training delivery initiatives shall be conducted in English.
Certification and Membership
Contact on +91-8103635949 or Info@skillbee.co.in for details of fees structure.
Assessment & Cetification
All the participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be certified as GCP Professional by Skillbee Solution.
Placement Assistance & Corporate Relations
The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry.
In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like IQVIA, Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare and Food industries on regular basis.