Clincial Data Management and Research Classroom Training in Hyderabad

Clincial Data Management and Research Classroom Training in Hyderabad

 

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    Clinical Data Management Classroom Training

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About The Event

Our Clinical Data Management and Research Classroom training classes are open for registration

Location: Hyderabad

 


Program Highlights: 

Optimal Duration: 2 months (requires approximately 60 hours of total reading) 

Ease of Training and Evaluation: Assignment based evaluation, no written examination Optimal Course Fee  Wide Recognition and Acceptance of the program throughout the clinical research industry      

Innovin IT Solutions Program Objective:

Professional Diploma in Clinical Research (PDCR®) is a skill development program (purely through correspondence) of 2 months duration with a primary focus on Drug discovery and clinical trial processes, Good Clinical Practices (GCP) guidelines, Drug regulatory affairs, Roles and responsibilities of various clinical trial stakeholders. The prime objective is to provide a highend training thereby enhancing the employment prospects of the participants.   


Clinical Research and It's Potential:  

India became a member of WTO/GATT/TRIPS in 1995 and implemented the product patent regime in 2005. As part of WTO/GATT/TRIPS, Pharmaceutical Industry has the rights to patent products as well as processes throughout the world including India. This has led to a significant growth in pharmaceutical industry and increased stakes of multinational companies in Indian operations.  


In light of these changes, Clinical Research has emerged as a leading knowledge based industry of the new millennium. Clinical research is carried out on healthy volunteers and patients with diseases to ensure that the drug, which is to be marketed, is safe and effective.  It takes approximately 12 years and US $1.3 billion to introduce a new drug to the market.  

Clinical Research industry in India is growing rapidly and the country is projected to conduct nearly 5% of all global clinical trials in next 5 years. Being a sunrise industry it is offering exciting career avenues as well as an accelerated growth path. Being a signatory of GATT/TRIPS, India is being looked upon as a favourable destination for conducting global clinical trials. 

India offers unique advantages for global clinical research that include:  

 

Lower drug development cost  

Abundance of patients with genetic diversity  

Wide spectrum of disease  

Trained medical professional

Skilled manpower and IT enabled infrastructure at a lower cost  

Proficiency in English language  

 

Clinical Research offers employment opportunities to the medicine/pharmacy/life sciences graduate and postgraduate students. However, clinical research is a highly specialized and regulated profession therefore it requires specific skill sets to carry out various operations, as per the global norms

Course Content:

CLINICAL DATA MANAGEMENT

 
STUDY PHASE: 

Protocol 

Preparation and finalization of CRFs 

Trial setup 

CRF Annotation Plan(DMP) 

Creation of dummy Data CRFs 

Creation of Edit checks and preparation of Dirty & Clean Data 

Data base Design and Format Testing 

DMP Finalization 

Data Entry Screen Testing 

Entry and Testing of Edit checks 

Go Data Base Live

CONDUCT PHASE: 

Receipt of CRFs (CRF tracking and filling) 

First Pass entry and Second pass entry 

Clinical Data Management 

Batch validation 

Auto coding & Manual coding 

Discrepancy management 

Data Clarification Form (DCF) 

DCF Resolutions 

SAE Reconciliation 

Quality control 

Data base lock 

Archival

CLINICAL RESEARCH 

Introduction, History and Work flow 

Drug discovery 

Preclinical studies 

Different phases of clinical trials 

Types of clinical studies 

Randomization 

IND studies 

Regulations & Reasearch associations 

Human subject protection guidelines 

ICH 

GCP 

Medical dictionaries 

21 CRF Part 11 

CDISC Inform consent 

AE & SAE 

Source document

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