A branch of medical science, clinical research is related to the effectiveness and testing of medications, diagnostic products, medical devices and treatment procedures for human use. These can be used for a disease’s treatment, prevention, diagnosis or for relief. Clinical research refers to the comprehensive bibliography of biology, drugs, and devices. It is a fast-growing discipline in India as the country’s large population and lower costs allow multinationals to establish research facilities here. Also, there many widespread diseases and ailments here, which makes it important to conduct clinical research trials here for the field of pharmaceutics. Clinical research is a scientific analysis of the impact, risks, benefits and efficacy of medicines or a medicinal product. These trials are done before the launch of the products in the market. The tests are undertaken at different stages and after-launch surveys are held to supervise the safety and monitor the side effects of large-scale use. The Contract Research Organizations (CRO) or pharmaceutical companies carry out the tests. It is a good time to become part of this fast-evolving industry.
Scope: India has been involved in clinical research for the past many years and is now on its way to becoming a major hub for it. The billion-dollar industry is already witnessing high demand for qualified professionals. There is a massive need for clinical research professionals in this fast-growing field. Clinical research makes an interesting career option with a great scope for professional growth. To build a career in clinical research, basic education in this field is necessary. To enter this field, a person must hold a degree of Bachelor of Science. The clinical research sector can be joined after graduation in pharmacy, life science bioscience and medicine. Bioscience further includes sub-disciplines like genetics, botany, biochemistry and zoology. People with educational qualifications from these fields can venture into this industry.
Qualification: Graduates and Post Graduates with specialization in B. Pharmacy / M. Pharmacy / PharmD / MBBS / MD / BDS / MDS / BAMS / BHMS / BPT / B. Tech (Bio-technology / Pharmaceutical Science) / BVSC / B.Sc. (Nursing) / B.Sc. or M.Sc. (Life Sciences) and all professionals working with CRO’s and Hospitals.
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 CDM.
Scope: Clinical Data Management (CDM) is an important department in pharmaceutical and contract research organizations that usually employs more people than any other department. This department is involved in overall collection and handling of clinical trial data. Data Management teams develop tools for collection of data at clinical trial sites, quality check the collected data for errors and raise flags in case any discrepancy is identified. They develop tools for verification, validation and quality control of the data gathered during the clinical trial. Clinical Data Managers ensure the integrity and confidentiality of collected data is maintained at all times. Various security controls are incorporated into the system to ensure that the data extracted from the clinical trials is secure and not prone to any open threats. Careers in Clinical Data Management are very promising. This field offers a wide scope of career options like Clinical Data Manager, Bio-Statistician, Clinical Data Co-ordinator, Clinical Data Entry Operator, Clinical Data Reviewer etc..
Qualification: Graduates and Post Graduates with specialization in B. Pharmacy / M. Pharmacy / PharmD / MBBS / MD / BDS / MDS / BAMS / BHMS / BPT / B. Tech (Bio-technology / Pharmaceutical Science) / BVSC / B.Sc. (Nursing) / B.Sc. or M.Sc. (Life Sciences) and all professionals working with CRO’s and Hospitals.
SAS (Statistical Analysis System; not to be confused with SAP) is a software suite developed by SAS Institute for advanced analytics, business intelligence, data management, and predictive analytics. It is the largest market-share holder for advanced analytics. SAS Clinical Data Integration organizes, standardizes and manages clinical research data and metadata. It provides the foundation you need to define analysis data sets and support strategic analyses such as cross-study and advanced safety analysis. With SAS, you can gain both speed and efficiency by automating repeatable clinical trial data integration tasks.
Scope: A plethora of technologies and the ever-increasing complexity, volume, regulatory requirements, and geographic spread of clinical trials is forcing companies to examine their core focus areas, while encouraging them to outsource clinical data management, SAS programming and biostatistics to a trusted partner. With the primary focus of a biopharmaceutical company or a CRO being science and research, they need a versatile technology organization with clinical research expertise to take care of all their data management, clinical programming and IT needs without incurring additional fixed costs.
Qualification: Graduates and Post Graduates with specialization in B.Pharmacy / M.Pharmacy / PharmD / MBBS / MD / BDS / MDS / BAMS / BHMS / BPT / MCA / MBA (Pharmacy) / B.Tech (CSE, IT, Bio-technology, Pharmaceutical Science) / BVSC / B.Sc. (Nursing) / B.Sc. or M.Sc. (Life Sciences, Computers, Mathematics or Statistics) and all professionals working with Pharmaceutical companies, CRO’s and Hospitals.
CDISC stands for Clinical Data Interchange Standards Consortium and it is developed keeping in mind to bring great deal of efficiency in the entire drug development process. CDISC brings efficiency to the entire drug development process by improving the data quality and speed-up the whole drug development process and to do that CDISC developed a series of standards, which include Operation data Model (ODM), Study data Tabulation Model (SDTM) and the Analysis Data Model ADaM).
SDTM stands for Standard data Tabulation Model, which defines a standard structure for study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA) 2. In July 2004 the Clinical Data Interchange Standards Consortium (CDISC) published standards on the design and content of clinical trial tabulation data sets, known as the Study Data Tabulation Model (SDTM). According to the CDISC standard, there are four ways to represent a subject in a clinical study: tabulations, data listings, analysis datasets, and subject profiles6.
Scope: SAS with Study Data Tabulation Model (SDTM) make programmers’ lives simpler but more repetitive. The similarity across studies of SDTM domain structures and relationships presents opportunities for code standardization and re-use.
Pharmacovigilance (PV or PhV), also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse with pharmaceutical products. Pharmacovigilance has its own unique terminology that is important to understand. Most of the following terms are used within this article and are peculiar to drug safety, although some are used by other disciplines within the pharmaceutical sciences as well. The principle of international collaboration in the field of Pharmacovigilance is the basis for the WHO International Drug Monitoring Programme, through which over 100 member nations have systems in place that encourage healthcare personnel to record and report adverse effects of drugs in their patients, reports that are assessed locally and may lead to action within the country.
Scope: Pharmacovigilance is still in its infancy in India, therefore higher standards of Pharmacovigilance are warranted to be at par with the rest of the world in terms of not only compliance to regulations but also to implement quality systems in all pharmaceutical companies especially the generic companies which manufacture bulk drugs that are marketed in India and the Western countries. There is no dearth of jobs in this field as good Pharmacovigilance practice makes for good business sense. Students of this field can get jobs in various pharmaceutical companies and expect attractive salaries with robust increments.
Qualification: Graduates and Post Graduates with specialization in B. Pharmacy / M. Pharmacy / PharmD / MBBS / MD / BDS / MDS / BAMS / BHMS / BPT / B. Tech (Bio-technology / Pharmaceutical Science) / BVSC / B.Sc. (Nursing) / B.Sc. or M.Sc. (Life Sciences) and all professionals working with CRO’s and Hospitals.
Medical coding is the transformation of healthcare diagnosis, procedures, medical services, and equipment into universal medical alphanumeric codes. The diagnoses and procedure codes are taken from medical record documentation, such as transcription of physician's notes, laboratory and radiologic results, etc. Medical coding professionals help ensure the codes are applied correctly during the medical billing process, which includes abstracting the information from documentation, assigning the appropriate codes, and creating a claim to be paid by insurance carriers. Medical coding happens every time you see a healthcare provider. The healthcare provider reviews your complaint and medical history, makes an expert assessment of what’s wrong and how to treat you, and documents your visit. That documentation is not only the patient’s ongoing record, it’s how the healthcare provider gets paid.
Scope:Medical coding and billing profession are highly recognized as one of the exciting career opportunities with a unique set of job duties for the medical and paramedical students across the globe. Maintaining the electronic health record of patients, so that they get paid off seamlessly by the insurance company is increasingly becoming a critical component of the healthcare industry. With the recent transition of medical coding process from ICD 9 to ICD 10 and the growth of Insurance sector in India; the healthcare industry is aggressively looking for well trained professionals with in-depth knowledge of their profession.
Qualification: Graduates and Post Graduates with specialization in B. Pharmacy / M. Pharmacy / PharmD / MBBS / MD / BDS / MDS / BAMS / BHMS / BPT / B. Tech (Bio-technology / Pharmaceutical Science) / BVSC / B.Sc. (Nursing) / B.Sc. or M.Sc. (Life Sciences) and all professionals working with CRO’s and Hospitals.
Regulatory affairs is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. The companies responsible for the discovery, testing, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. The regulatory professional’s job is to keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products. They also advise on the legal and scientific restraints and requirements, and collect, collate and evaluate the scientific data their research and development colleagues are generating.
Scope: Due to the entry of the MNCs and in new era of pharmaceutical MNCs market consolidation, the job opportunity of pharmaceutical regulatory affairs personnel is going to soar up and more than 30,000 competent regulatory workforce is required in India in next 5 years to match the demand of the regulatory affairs professionals
Qualification: Graduates and Post Graduates with specialization in B. Pharmacy / M. Pharmacy / PharmD / MBBS / MD / BDS / MDS / BAMS / BHMS / BPT / B. Tech (Bio-technology / Pharmaceutical Science) / BVSC / B.Sc. (Nursing) / B.Sc. or M.Sc. (Life Sciences) and all professionals working with CRO’s and Hospitals.