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Clinical Data Management
Clinical Data Management

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.

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CDM Questions & Answer
CDM Questions & Answer

We have Pharmacovigilance, Clinical Trail and Clinical data Management, Medical Writing Interview Questions and Answer session

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Clinical Research, Clinical Trial, Clinical Data Management
Clinical Research, Clinical Trial, Clinical Data Management

Course Include Clinical Research, Clinical Trial, Pharmacovigilance, Clinical Data Management and Medical Writing

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Clinical Data Management
Clinical Data Management

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.

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Clinical Data Management Courses & Training Online

Company Connect Consultancy 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

Company Connect Consultancy offers top quality courses in clinical research, Clinical Data Management and Data Analysis with strong emphasis on practical training and projects.

Company Connect Consultancy 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 Company Connect Consultancy 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.

Clinical Data management Section 3 of Pharmacovigilance Course

  • Module 1.Clinical Trail Process and Design

  • Module 2.ICH-GCP and GCDMP

  • Module 3.Clinical Data Management Systems

  1. CRF Design

  2. Data Entry & Data Collection

  3. Data Load/Transfer

  4. Data Storage

  5. Data Validation

  6. Data Export (SDTM)

  7. Query Management

  8. Data Archiving

  9. Quality Systems,SOPs and Audits

  10. Safety Management and Pharmacovigilance

  11. Data Management Systems and Tools

  12. Medical Codings and Medical Dictionaries

  13. CDMS, AERS,EDC,OCTMS

  14. 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 Company Connect Consultancy

  • 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

Registration

The registration will be carried out by contacting on Company Connect Consultancy. How to Apply

Programme 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 Fees

Contact on +91-9691633901 or Info@companysconnects.com for details of fees structure 

Assessment & Certification

All the participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be certified as GCP Professional by Company Connect.

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.

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