The clinical data management Hub

Today clinical research industry has achieved growth from Rs. 20 crores to Rs. 100 crores. Clinical research, Clinical trial, Clinical data, clinical content management are all inter-related field and fall under the scope of biotechnology, microbiology, biochemistry and genetics.

Mother subjects like biotechnology, microbiology biotechnology is no more restricted to petriplates, pipettes, conical flask and chemicals-which is know as ‘wet lab systems’. It has expanded its wings to ‘dry labs system’. The dry labs basically emphasizes on -Sequence analysis, drug toxicity, pharmacokinetics studies, market analysis, biometrics (statistical analysis), regulatory affairs of new drugs, which in turn makes up the clinical data management studies. Dry Labs use software and other programming languages to accomplish data management work. Now researchers are combining proteomics, genomics with modern technologies, in order to make biological data systematically organized into databases and easily accessible to common people.

Basically any data related to clinical, health care, or medical studies is known as clinical data and managing these data in order to reduce the possibility of errors due to human entry is known as "clinical data management systems". Getting into the details of this field, it basically deals with new drug discoveries, its efficacy and efficiency to serve the human race. The process is something of this kind:

•     A drug is developed

•     Drug’s efficacy and toxicity level tested on animals (preclinical studies)

•     Drug’s efficacy, efficiency and toxicity needs to be tested on humans (clinical studies)

This whole study process is taken care by the CRO'S - contract research organizations.
 While the data gathered during the above mentioned process needs to be collected, validated, data entry has to be made, analysis(statistical analysis), maintained in database. These tasks are performed by SMO's - site management organization. The SMO'S and the CRO'S together form what is known as RMO- Research Management Organizations. Hence CRO’s and SMO’s deals with clinical data management projects.

Accordingly job profile changes with the kind of institute you are linked up with. CRO concentrates more on fieldwork like-Visiting the investigation sites, Monitoring the trials, Monitoring the patients data-CRF forms, Checking the ethical issues of the trial, Informed consent of the patients etc. Whereas SMO becomes an office oriented work, where each data needs to be closely scrutinized, validated, analyzed, planning of budget development of the trial, business development, medical coding etc.,

India is global hub of outsourcing for clinical trials, since it has got high population of cancer patients, wide spectrum of diseases such as cancer, diabetes and other maladies. Pharma companies, the major players in the world are attracted towards India as one of the clinical research destination since it has got huge patient population, multi specialty hospital beds, medical colleges with efficient investigators and trial personnel and skilled English speaking professionals.

The major aspects which is taken into count while conducting Trials in India are:

•     High population rate

•      Specialty Hospitals

•      Availability of talented doctors

•      Skilled professional

•      Sufficient sales potential (marketing of drugs)

•      Patent protection act

•      Cost effective.

This field can offer its professionals with good career progression, increase in income, exposure to cutting edge technology, and immense chances of overseas travel. It can provide opportunities to best minds in the industry. Starting from entry-level jobs as clinical research associate and coordinators to Clinical Project managers and business development managers it is a promising path of success. Thus the main aim lies in developing protocols and maintaining medical data, medical codes in compliance with GCP (Good clinical practice). Good Clinical Practice guidelines provide ethical and scientific standards for designing, conducting, recording, reporting, monitoring, auditing, analyzing and reporting clinical trials. Hence it is a kind of extracting high quality data by proper validation and statistical analysis and forecasting future results with greater predictability.