Introduction to Clinical Research- Up growing career option for life Science Students

1. Introduction to Clinical Research- Up growing career option for life Science Students What is clinical research? Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. Who conducts Clinical Research? There are different stakeholders who serve the major roles in clinical trials /research 1. Sponsor–Any pharmaceuticals company who formulates or discovers the molecule which is being a newly developed drug for clinical trials. 2. CRO (contract research organizations) - this is the organization who takes the responsibility to conduct and carry the trial with the help of well-equipped facilities and investigators. The major role of CRO is to conduct a trial which is compliance to the guidelines and they perform all the activities regarding trial recruiting staff under them also coordinate and handle the whole trial project for a particular trial 3. SMO (Site management organizer) - The SMO is the organization which performs all the activities are conducted at the site/hospital. 4. PI (Principal Investigator) - This is the main stakeholder, who responsible for the all activity conducted and perform during a trial he is the only person who is designated as a principal investigator which is the qualified as well as the experienced doctor.

2. 5. Regulatory bodies- CDSCO, DCGI, FDA these all are the regulatory bodies who approves the trial regarding documentation and practical implementation with the help of ICH-GCP guidelines. Drug regulatory officers are responsible to approve these guidelines. 6. Data management team–The IT-based organizations, who serves the major role during trial because at the time of trial the activities which are to be held should be documented and if nothing is documented there is nothing to happen so for this all documents which are generated at the site should be electronic format so here there are so many activities has to perform like medical coding, medical summarization, medical writing, medical reviewing. 7. Pharmacovigilance - during the trial there might be some adverse events and serious adverse events may occur for this the PV team can perform all the activities while from reporting to the resolution of this AE/SAE Why go for clinical research? Today, clinical research course is one of the most booming fields in the healthcare sector and the pharmacy industry. There are so many job positions available for life sciences graduates along with for pharmaceutical graduates with highest salary packages and good designations. Clinical research now at its highest level just because this field is no established with IT companies where all the topmost IT sectors like TCS, ACCENTURE,SCIFORMIX, INFOSYS, SYNTEL all had their life sciences units for clinical data management and hiring the graduates and postgraduates with life sciences background and medical as well as pharmaceutical background. So, this is the time to start our career in this most blooming health care industry with attractive salary and secure n richest designation. Career Opportunities in clinical research The life science and pharmaceutical Industry is full of employment opportunities, although the industry needs skilled professionals to cater

3. to the increasing demand. Clinical Research & Pharmacovigilance training conducted by Clariwell Global Solutions is exclusively designed to provide employability for both fresher as well as experienced candidates. It becomes exceptional professionals in the arena of CR and healthcare. Graduates of this program may secure lucrative jobs in reputed healthcare companies as:- • CR Associate • Project Manager- CR • CR Investigator • Medical Coder • Drug Safety Officer • Medical writer • PV coordinator • PV Associate • Data Manager • CR Manager • Biostatistician • Regulatory Affairs Associate • Clinical Trials Auditor • Clinical Project Manager