Clinical Trial -Exltech - PowerPoint PPT Presentation

clinical research exclusive job oriented training by exltech n.
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Clinical Trial -Exltech

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  1. Clinical Research- Exclusive Job Oriented Training byExlTech Introduction to ClinicalResearch Clinical Research is a most knowledge intensive and interesting field in pharmaceutical industry. The billion dollar industry is demanding the employment opportunities of qualified and trained professionals in clinical researchsector. What is clinical research? Clinical research is a branch of healthcare science that determines the safety and effectiveness 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 research evidence is collected to establish a treatment for particular disease. Clinical research aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, tissues, or othersamples Types of Clinical Research The clinical research is categorized into two typesmainly Comparative Clinical Research It is also known as controlled clinical trial. The research participants are divided into two group’s one group receives the investigational treatment, while another group either records the conventional (traditional) treatment or nothing. The control group might be given a fake treatment. This is an idle pill, injection or implantation that seems similar to the investigational treatment. The treatment conducted is kept confidential that means patient and physician both are unaware that who is acquiring the investigational treatment. Open Label Clinical Research

  2. In this type the patient and physician both know that the investigational treatment is going to conduct. Phases of Clinical ResearchTrial There are main phases of clinical trials: Phase I, Phase II, Phase III and Phase IV. The four phases of the drug approval process are separate clinical trials, and the entire process typically takes eight to 10years. Phase I In this phase the first drug treatment is carried out on a small group of people. Investigator or a scientist figure out the drug’s safety, determine a safe dosage range and analyze its sideeffects. Phase II In phase II same procedure is followed as phase one but the treatment is carried out for the large number of people to observe its behavior and safety. Phase III The drug treatment is conducted for larger group of people. In this phase scientists or observer confirms effectiveness of a drug on particular disease, monitors its side effects, compare with traditional treatments and gathers all the information about the experiment so that the drug is been used safely in future. Phase IV Phase four deals with the post marketing studies that are conducted after a treatment will be approved for commercial use by FDA. Post marketing study includes all the required information about the drug along with its hazards, profits and best usage. Scope of Clinical Research inIndia Clinical research is having great opportunities of career. As explained earlier there are many phases in clinical research coursefrom the manufacturing of the drug to its commercial usage there are lot many opportunities for clinical research professionals available at each and every stage with up growing and endless career.

  3. India is becoming an emerging hub for pharmaceutical industry because of the clinical trials conducted in India. ExlTech is one of the best clinical research training institutes in Pune committed to deliver best in the subject with 100 % placement. Following are some important points which are responsible for it, Indian clinical research industry has very strong fundamentals including • • • • Vast population in need of medicaltreatment Qualified medical professionals Availability of required infrastructure Clinicians and data specialists • Good regulatorypolicies • JobOpportunities • Parma clinics, Hospitals, regulatory affairs, CROs • Popular Designations • Clinical ResearchManagers • ClinicalResearchAssociate • Drug SafetyAssociates • Regulatory AffairsManager • Investigators andCo-investigators • Medical Writers • Site Coordinators • Clinical TrialAnalysts • Clinical Research Coordinator • Business Development Manager • Clinical DataManager

  4. PharmacovigilanceExecutive • Biostatistician • Clinical TrialsAuditor • Follow: •