Clinical Data Management is an important part of clinical research. It processes high quality, reliable and statistically sound data with the help of computer applications and database systems to support the collection and management of clinical trial data. Why do we need clinical data management?
It’s because they are the ones who collect the data during a clinical trial and perform the safety and efficacy analysis which in turn helps in decision making on product development in pharmaceutical industries. Hence the clinical research staffs must be trained and qualified for performing the tasks.
The members consist of the clinical data manager, database administrator, database programmer etc. The major responsibilities are to collect, store, process the information of clinical research. They are also responsible for evaluating the end results of a trial or research. There is huge career growth in India for this. India has one the fastest growing sector which is the pharmaceutical industry.
There is a massive need for such managers. To build a career in this field a person must have a background in life science, medical, pharmacy, dental, physiotherapy, nursing, paramedical science, and biochemistry. Clinical data management training is provided for to the students where they learn to be responsible clinical data managers. These days CDM RAVE training is also provided.
RAVE is a single database for both EDC and CDM. EDC is known as Electronic Data Capture. RAVE is an industry leader in the EDC system. It is designed to study tools that nullify the need for programming skills. It is a single, flexible, scalable platform which captures, manages and reports clinical research data.
There is a lot of opportunities in clinical data management jobs and also it gives economic benefits. The Indian pharmaceutical market is expected to be among the global top three by incremental growth by 2020.
It is expected to be the sixth largest market in terms of absolute size in the world. After 2013 the clinical trial industry in India is showing an upward trend by the ‘Make in India’ initiative by the Indian government. So there are a few reasons for robust growth in this sector in 2017 and they are:
- Regulatory procedures getting simplified: There were ambiguity and uncertainty which was related to regulatory procedures in before time. This led to a showdown in the number of clinical trials approved in the country. But now the approval process is quicker and in line with global practices because of new updates.
- Latest proactive steps taken by the government: The aim of the government is to speed up approvals, remove middlemen and bring transparency to the new guidelines.
- Motivation to local stakeholders in clinical research: The restriction that did not allow to conduct more than three clinical trials at any given period was removed by CDSCO.
- The growth of global incentives: The new US president changed some policies that will have a positive impact on clinical data management.
CDM‘s ultimate goal is to protect public health and create confidence in the world of therapeutics.