CLINICAL TRIALS AND SAFETY DATA MANAGEMENT
Qtech Solutions Inc (dba Qtech-Sol Clinical Science Institute) offers Student Introductory Program, Career Pathway, Practicum programs and Vocational Domain certificate programs. Our Introductory, Intermediate and Advanced programs are designed for freshers , career changers or experienced to gain additional knowledge and work exposure needed for career advancement. Qtech-Sol (Canada) specializes in providing self-paced online training programs and solutions for Clinical Trial Management, Monitoring, Pharmacovigilance, Clinical Data Management and Clinical SAS Programming. Qtech-Sol (Canada) training emphasizes on Good Clinical Practices (GCP), Regulatory and SOPs as followed by FDA, EMA and Health-Canada, to conduct clinical trials, monitoring, drug safety, pharmacovigilance, clinical data management and clinical sas programming.
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CAREER FOCUS PROGRAMS
Qtech-Sol (Canada) offer cost-effective self-paced online programs focusing on title and job focused for Clinical Research, Drug Safety and Data Management. Whether you’re a student or looking to make a career change or preparing yourself for entry into the workforce, we can help.
CLINICAL RESEARCH AND PROJECT MANAGEMENT
Are you passionate about clinical research and want to be part of a research team to conduct clinical trials? Want to be a clinical research manager in a pharmaceutical , CRO or research hospital. You must have an associate’s or bachelor’s degree in biology, biochemistry, biotechnology, chemistry, medicine, nursing, public health and other healthcare majors to qualify. At Qtech, we strive to achieve your career goals and make you successful.
WHAT IS A CLINICAL STUDY / TRIAL?
Clinical research is medical research that involves people. Clinical trials are research conducted on people to evaluate medical, surgical, or behavioral interventions. Researchers have discovered whether new therapies / new drugs, diets, or medical devices are safe and effective for people. Often, clinical trials are used to find out whether new therapies are more effective and/or have fewer harmful side effects than standard therapies. Clinical trials of drugs are often described in terms of their stage. (I, II, III and IV).
THE ROLE OF CLINICAL RESEARCH PROFESSIONAL
It is the responsibility of the clinical researcher to ensure that these trials are conducted ethically with good clinical practice and that all team members adhere to strict regulations. They must handle documents and materials carefully and safely. Overall, researchers are responsible for recruiting and screening patients, maintaining patient care in terms of health and progress, and then submitting results to sponsoring organizations upon completion.
The Clinical Research Associate (CRA) can be hired directly by the sponsor company of a clinical trial or by a contract research organization (CRO) (also known as a clinical research organization), which conducts clinical trials on behalf of the sponsor company. The Clinical Research Associate (CRA) is also called a clinical trial monitor. They have a broad description of their work, but their main responsibility is to ensure the rights, safety, and well-being of the participants in clinical trials. The Clinical Research Associate (CRA) serves as the primary means of communication between the sponsor and the site. A clinical research Associate / Assistant (CRA) professional sets up, monitors, and closes clinical trial sites assigned to him/her. Depending on the level of experience, CRA is usually hired by employers at CRA I, II and III levels.
Are you passionate about drug monitoring or surveillance and keen about the safety of patients, this career pathway will interest you. Do you have a degree in medicine, pharmacy or nursing? Well, this career path and plan is perfect for you. At Qtech, we strive to achieve your career goals and make you successful.
Drug safety is the main aspect of medical therapy that can play a major role in deciding which drug should be given to a patient. Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
THE ROLE OF DRUG SAFETY PROFESSIONAL
Drug safety associates or assistants work in the medical industry to monitor the safety of medicines and to assess and prevent adverse reactions in patients. A pharmacy safety profession (also known as pharmacovigilance) can include working with clinical research organizations conducting trials, biotechnology companies, pharmaceutical companies, or government agencies such as the National Institutes of Health (NIH). Drug safety assistants need excellent research skills, a solid medical or biological science background, and a deep understanding of the Food and Drug Administration (FDA), European Medicines Agency (EMA) guidelines and regulations. Your responsibilities include analyzing clinical trial data, writing reports, and determining whether a particular drug is safe.
CLINICAL DATA MANAGEMENT AND SAS
Are you passionate about clinical data analysis and reporting, research, database design, data analysis and modeling, and want to be part of a clinical research team to support clinical trials? This career path is best for you. You must have a bachelor’s degree in statistics, mathematics, computer science, biotechnology, medicine or healthcare administration to qualify. At Qtech, we strive to achieve your career goals and make you a successful clinical data manager or SAS data analyst.
Clinical research is medical research that involves people. Clinical trials are research conducted on people to evaluate medical, surgical, or behavioral interventions. Researchers have discovered whether new therapies / new drugs, diets, or medical devices are safe and effective for people. Often, clinical trials are used to find out whether new therapies are more effective and/or have fewer harmful side effects than standard therapies. Clinical trials of drugs are often described in terms of their stage. (I, II, III and IV)
ROLE OF CLINICAL DATA MANAGER
Clinical Data Coordinators handle clinical information like patient records, appointments, studies, and other official documents. Their role is coordinating activities which relate to clinical administrative tasks and recording data for study and validation.
Clinical data managers are responsible for collecting data from a variety of medical research projects, such as clinical and pharmaceutical trials. They work collaboratively to make sure data is collected, managed and reported clearly, accurately and securely.
ROLE OF CLINICAL SAS PROGRAMMER
SAS is widely used in clinical trial data analysis in pharmaceutical, biotech and clinical research companies. SAS programmers play an important role in clinical trial data analysis. In addition to doctors and clinicians who collect clinical trial data, the group conducting data analysis includes statisticians, clinical data managers (CDMs) and SAS programmers. Statisticians provide the ideas and methods of the data analysis, clinical data managers manage the collected data and control the data quality. In between, SAS programmers implement the analysis methods on the collected data and provide the study summary tables, data listing and graphs to the statisticians and for clinicians to write study report.