An Understanding Into the Field of Clinical Research and Clinical Trials

1. An Understanding Into the Field of Clinical Research and Clinical Trials https://www.technobridge.in/clinical-research-course.html

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3. INTRODUCTION • Massive Demand for Clinical Research Professionals • Steps in the Clinical Trials Process Clinical research course https://www.technobridge.in/clinical-research-course.html

4. Clinical research course Massive Demand for Clinical Research Professionals • The clinical research industry is a booming industry, growing at an exponential rate and thus is opening a wide scope of job opportunities for trained professionals who have completed clinical research courses. • There are a wide range of clinical trials conducted to collect the data regarding the safety and efficacy of new drug and development. Clinical research courses give professionals the required information. https://www.technobridge.in/clinical-research-course.html

5. Clinical research course Steps in the Clinical Trials Process • There are several steps and stages of approval in the clinical trials process before which either a drug or a device can be sold in the consumer market. Drug and device testing begins with extensive laboratory research which can involve years of experiments inhuman cells. • If the initial laboratory research is successful, researches send the data to the regulatory authority for approval to continue research and testing in humans. • Once the initial research is approved, professionals commence the testing of drugs and devices can begin and is typically conducted in four phases. Each phase is considered a separate trial. https://www.technobridge.in/clinical-research-course.html

6. Clinical research course • After completion of a phase, investigators are required to submit their data for approval from the regulatory body before continuing to the next phase. https://www.technobridge.in/clinical-research-course.html • The Five Phases of Clinical Trails Given below are the four clinical trial phases in detail. https://www.technobridge.in/clinical-research-course.html

7. Phase I : • Studies evaluate the safety of a drug or device. This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers (20 to 100), who are generally paid for participating in the study. • The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. • This phase also investigates the side effects that occur as dosage levels are increased. About 70% of experimental drugs pass this phase of testing. • Clinical research courses teach professionals to carry out an efficient phase. Clinical research course https://www.technobridge.in/clinical-research-course.html

8. Clinical research course Phase II • Studies assess the efficacy of a drug or device. This second phase of testing can last from several months to two years, and involves up to several hundred patients. • Most phase II studies consist of randomized clinical trials where one group of patients receives the experimental drug, while a second "group receives a standard treatment or placebo. In most of the cases, the studies are blinded which means that neither the patients nor the researchers know who has received the experimental drug. • This allows investigators to provide the pharmaceutical company and the regulatory body with comparative information about the relative safety and effectiveness of the new drug. https://www.technobridge.in/clinical-research-course.html

9. Clinical research course Phase III • Studies involve randomized and blind testing among several hundred to several thousand patients. • This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions. • Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug.Clinical research courses gives all the information about legal regulations. https://www.technobridge.in/clinical-research-course.html

10. Clinical research course Phase IV • Studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage. • Comparison of the with other drugs already existing in the market. • Monitor a drug's long-term effectiveness and impact on a patient's quality of life. • To determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies https://www.technobridge.in/clinical-research-course.html

11. Phase V • Studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study. • Clinical research courses give pharmacovigilance aspirants the required information for this phase. • To conclude, clinical research professionals need to be extremely competent and qualified to conduct these clinical trials. • Therefore, it necessitates the need for professionals to enroll in clinical research courses and obtain certifications from a renowned clinical training institute. Clinical research course https://www.technobridge.in/clinical-research-course.html

12. Clinical research course THANK YOU https://www.technobridge.in/clinical-research-course.html