Why CDM

As subjects get bifurcated, job profiles are getting diversified. Back in the days there were pure science subjects such as physics, chemistry and biology. Physics later gave way to branches such as radio- physics; chemistry got diversified with cheminformatics and biology as bioinformatics.

With a growing range of subjects, job requirements have undergone massive changes. Today one such preferred industry is Clinical Research Industry. During the last three years this 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.


New drug discovered
(Clinical trials)
CRO
(Trial performance)
RMO
(CRO+SMO)
SMO
(Maintaining data of trial)
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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. Most IT or software companies involved in clinical trial management projects can be called SMO, as it requires least field work of monitoring trials and visiting the trial locations or the investigating sites. Setting up an SMO needs less investment and minimal infrastructure set up. Few such software firms outsourcing clinical research projects are:
Accenture.
Infosys
IBM
TCS
Cognizant Technologies
ICTEAS

CRO'S employs professionals such as- CRC (Clinical research co-coordinator), CRA (clinical research associate), senior clinical research associate, project managers, Investigators etc. SMO's employs-CDC (clinical data co-coordinator), clinical data analyst, clinical project managers, biostatistician, medical writers. Now life science candidates have more choice in their field. It is not only restricted to wet labs but also dry labs with bioinformatics, clinical research, and clinical data management gaining more popularity. It mainly deals with knowledge outsourcing and it’s quite a lucrative field for both the employer and employee.

These organizations ensure smooth, accurate progress of clinical studies from product development, planning and approval stages through study completion and post-study closure. It is essential to prepare documents for submission for review by the Institutional Review Board (IRB), next recruiting and screening study participants, coordinate their clinical treatment and follow-up their treatment as it proceeds further, and counsel them as and when required to enable their continued participation in the trial;
Similarly data collection from medical records, journals, abstract curation, submitting data and maintaining study data and regulatory documents; developing and ensuring compliance with study protocols; and participating in the method development, and budgeting for clinical studies or clinical trials all forms a part of clinical trial data management.

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.

Another major aspect is the cost factor; the cost of drug trial gets drastically reduced when a particular trial is being conducted in the Indian sub-continent. Today big pharma giants like Glaxo, Aventis, Abott pharmaceutics, Bristoll –Myers Squibb, Covance, Novozyme, Eli Lilly, Pfizer, Novo Nordisk is showing their interest in showcasing their drugs by conducting trials at various Indian cities.

In order to make this clinical research more popular and accessible to common people- ‘online clinical trial registry’ is being set up. This trial registry gives information of the various ongoing open trials. Indirectly it is popularizing the whole concept of drug discovery, efficacy, and attracting more trial participants or volunteers. These registries are improving the transparencies of trials by disclosing the patient accrual, dose administered, drug combinations, side effects related, patent status of the drug, investigators details (attached to a particular trial). As a result a clear picture is put up before patients or participants that might lead to enhancement of public tolerance and confidence towards Clinical Trials in India.
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.
Among all the cities Hyderabad runs the highest number of CRO’s, next in line are Bangalore, Mumbai and Delhi. Quintiles, Dr. Reddy’s Lab, Reliance life sciences of Bangalore, Hyderabad, and Mumbai respectively are expanding their data management team. Need for clinical trial professional, biostatistician are ever increasing. Pharma giants have joined hands with pharmaceuticals and biotech industry such as TCS has joined hands with Eli Lilly and Novo Nordisk, Accenture with Wyeth group.

To make the identity of clinical data manager professional prominent various clinical data management society is being formed for example:
Association of clinical data managers (ACDM).
Society for clinical trials
The American statistical association
The Regulatory affairs professional society.
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.

Source : Biospectrum

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