Best Clinical Research courses and Pharmacovigilance Training is designed by industry experts. Clariwell is an exclusive platform to dream up a career and flourish the future, this Clinical Research and Pharmacovigilance training is the best selection for the students from life science stream and enthusiastic towards research. Our programs have been rigorously designed to best suit those seeking to enter the field of healthcare IT or clinical research, and most of our students are Life Science graduates with a Bachelors or a Master’s Degrees in Science/Arts, Pharmacy, Medicine or Nursing.
Clinical research is a growing industry which offers advantageous career options to the pharmaceutical graduates. It plays a vital role in introducing new drugs and improving health statistics. In India, the scope of clinical research is raising its global standards to introduce new medicines to cure various illnesses. In the upcoming years, India is going to become a global hub for clinical research. Various established firms are taking initiatives to place students professionally in this field. Clinical Research Training is conducted at various affiliated academic medical centers and research centers. They provide quality learning ecosystem which involves networking sites, pharmaceutical companies, emerging technologies, managing data and various operational factors related to this field. There are various job opportunities in the larger pool of medical aspirants in metro cities.
The eligible candidates are trained by Experienced Trainers to give a real-time corporate experience The Candidates are trained in various aspects including communication skills, resume & presentation development, interview preparation. Our Placement cell continuously provides support to the candidates for placements because of which we commit to 100% written guarantee. The candidates who have done professional Clinical Research Course from Clariwell Global will definitely look outstanding among others and they have very bright success path.
Today, clinical research 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 the 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, Freshers can opt for the clinical Research course and start their career in the most astonishing health care industry with attractive salary and secure jobs with richest designations.
The life science and pharmaceutical industry are full of employment opportunities, although the industry needs skilled professionals to cater 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 has become exceptional professionals in the arena of CR and healthcare.
Clinical research is a clinical or biomedical study of drugs through the use of human subjects. Clinical studies do not necessarily involve medical treatments or experimental therapies. It can include observational studies, in which people are followed over a period of time to determine health outcomes. Clinical research may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. In clinical practice, specific predefined treatments conducted during are used, while in clinical research evidence is collected to establish a treatment. It may also be used to determine the efficacy & safety of a new diagnostic procedure or drug treatment. Clinical research is a pre-planned activity and it follows a defined protocol. Clinical trials are one important type of clinical research. To enter in this ever-growing sector candidates can choose professional clinical research courses.
Clinical trials are a form of clinical research that follows a defined protocol that has been carefully developed to evaluate a clinical study of a drug. There is one more definition of clinical research proposed by National Institutes of Health (NIH) of United Status - "A prospective biomedical or behavioural study of human subjects that is developed to evaluate specific investigation about biomedical or behavioural interventions (such as drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)."
Different stakeholders serve the major roles in clinical trials /research
1. Sponsor –Any pharmaceuticals company that formulates or discovers the molecule which is being a newly developed drug for clinical trials.
2. CRO (contract research organizations) - this is the organization that 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 that is compliance with 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 that performs all the activities that 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.
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
In simple words, Clinical data management is the collection, integration, and validation of data obtained from clinical research trials. The management of clinical data is been trained in Clinical Research Courses itself but some institutes offer a specialized training program for Clinical Data Management. During the clinical trial, the investigators collected data on the patient’s health for a defined period. This data is sent to the sponsor, who then analyzes the pooled data using statistical analysis. Clinical data management (CDM) is an essential term in the data collection phase of clinical research. The process of collecting and managing research data is done by regulatory standards to obtain quality information that is complete and error-free; the goal is to gather as much of such data for analysis as possible.
Each trial has specific inclusion and exclusion criteria to determine the patients who match the exact criteria that may participate. Individuals with exact match the predefined and preapproved inclusion criteria for a trial may participate in the trial and are currently accepting participants. Inclusion criteria are decided on factors such as patient age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Some clinical trials require participants with illnesses or conditions to be studied in the trial, while others need healthy participants.
Pre-clinical studies are also known as laboratory studies, these are often the first steps in developing a new drug treatment before testing it on people. It includes cell-studies and animal testing. Development of new treatments is usually a very lengthy process, which can take years: several tests in the laboratory and on animals are necessary before researchers can involve volunteers in a clinical trial of a new drug. Some of the potential new treatments get to this point and even fewer go through the different phases of clinical trials.
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