ROLE OF TECHNOLOGY IN CLINICAL TRIALS

ROLE OF TECHNOLOGY IN CLINICAL TRIALS

Clinical trials are conducted for research purposes and are performed on volunteers. Clinical trials are focused on studying different diseases and their effects on the human body, both mentally and physically. Clinical trials are the primary methods used by clinical researchers to test whether a whether a new drug, new medical device, or new diet is effective and safe for people. All the research is done to develop diagnostic methods and new treatments to safeguard patient care.

For better clinical research, highly professional and trained researchers are needed to ensure seamless research, as it can be dangerous to some people if proper care is not taken during research. For highly professional researchers, clinical research certification is necessary to ensure the professionalism of the candidate. For the moment, Fusion Technology Solutions is offering a clinical research certificate program for students who are willing to join clinical trials as a career opportunity. Keeping in mind the impact of the COVID pandemic, Fusion Technology Solutions is also offering online clinical research courses.

Clinical trials are believed to be still pen and paper type of research, but in reality, technology is centralizing in all the organizations around the globe, and clinical research is not an exception. Technological advancements are needed for the future, and that applies to clinical trials too. Suppose we have to track the heart rates of the volunteers in a clinical trial, so we have to organize it in a proper manner to ensure proper data management for further use. This data cannot be organized properly with pen and paper, and we have to use a heart rate measurement device for it. This gives us a slight insight into the factinto the fact that technological penetration is at the highest level in clinical research. Hence, technological knowledge is more important in clinical research.

Fusion Technology Solutions is the Best Clinical Research Training Institute.

for it. Here, candidates are trained on dummy projects for experience purposes by experts in the respective fields. In the handling of data for future use, data management is the key segment to focus on. Data management involves proper segregation of data and analyzing reports on the basis of studies performed in clinical trials. For this purpose, the candidate has to submit a data management certification to the respective organization. Fusion Technology Solution is offering a clinical data management course for the purpose of hands-on project work. Clinical data management team members are involved in clinical research from the beginning of trials. Adequate process knowledge is very important in the clinical data management process. Case report form design, data design, data validation, medical coding, and data extraction are various procedures involved in data management. All the above-mentioned data management courses are involved in the clinical research courses, especially because CDM standards have to meet regulatory requirements. The CDM team has to meet high standards of data quality, as it is mandatory for all clinical research institutes to submit the data electronically within a specific period of time.

Furthermore, analyzing the side effects on the patients and calculating whether these effects are harmful for the patients or not is the most challenging task in clinical trials. For this purpose, Fusion Technology Solutions is offering pharmacovigilance courses. In pharmacovigilance courses, candidates are trained to use different medical devices, like heart mapping devices, ultrasound and MRI machines, CT scanners, X-ray machines, and LASIK machines. Also, clinical trials are carried out on these machines in order to check their accuracy and identify malfunction occurrences, if any. The classification of medical devices is given by the US Federal Health Administration. Medical devices are classified into class 1, class 2, and class 3 types of devices, where class 1 devices denote a low risk of patient health while class 3 devices denote a high risk of patient health. Pharmacovigilance courses in Fusion Technology Solutions are especially set up in such a way that clinical researchers will get full study and hands-on practical experience on medical devices. The clinical research course syllabus is set by experts in such a way that candidates will get full experience of clinical trials even before starting actual clinical research projects. The entry level of pharmacovigilance course completion is the job of a Drug Safety Associate (DSA). The role of DSA’s is to check minimum safety information and reconcile data.

The required skillsets for pharmacovigilance course professionals are:

  1. Knowledge of medical coding
  2. Basic knowledge of rules and regulations
  3. Understanding of medical terms and processes
  4. Good knowledge of scientific writing
  5. Good communication and interpretive skills.

The use of CT scanners in clinical trials involves detailed cross-section and internal images of internal organs and blood vessels, soft tissues and bones, etc. This information is collected for further studies of drugs and medicines on different organs of the body. LASIK machines are used for collecting data on the eye and internal parts of the eye for further studies on color blindness, color configuration, and retinal imaging in volunteers.

Imaging is a very crucial part of online clinical research courses, as the cost of drug development and the characterization of drug efficacy and safety are in prime position for clinical trial institutes. The study of molecular medicines and genomics is ever-growing and expanding in clinical trials as more discoveries are made every day in the medical sciences. Multi-center imaging is standardizing and becoming a crucial part of imaging technology. Image analysis and data acquisition are the key skills required for this purpose. This data is used for the post-approval stage of medicines and drugs in order to analyze the effects of medicines on the human body after ingestion. The go-or no go method is carried out after process completion, as reconciliation of data is made according to the clinical trials done. Clinical trials should be done in phases given as follows:

Phase 1: Giving doses to healthy volunteers for safety.

Phase 2: Testing of medicine on volunteers to test the drug efficacy

Phase 3: testing medicine and assessing the effectiveness of medicine.

Phase 4: post-marketing survey in public.

Conclusion:

The role of technology is playing a very crucial role in clinical trials, as all the methods are data-centric in every organization for research and development purposes. Technological advancements in big data, pharmacovigilance methods, and medical device efficacy are on the rise as there is increasing competition among institutes involved in clinical trials.

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