ROLE OF TECHNOLOGY IN CLINICAL TRIALS

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

For the 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. Keeping in mind the impact of 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 in it. Technological advancements are need for the future and that applies for clinical trials too. Suppose, we have to track heart rates of the volunteers in clinical trial; so we have to organize it in 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 heart rate measurement device for it. This gives us a slight insight that technological penetration is at the highest level in clinical research. Hence, technological knowledge is more important in clinical research. Fusion Technology solution is the Best Clinical Research Training Institute for it. Here candidates are trained on dummy projects for experience purpose from experts in the respective fields.

In 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, candidate has to submit data management certification to the respective organization. Fusion Technology Solution is offering clinical data management course for the purpose with 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 clinical data management process. Case report form designing, data designing, data validation, medical coding, 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 the regulatory requirements. CDM team has to meet high standards of data quality as it is mandatory to all clinical research institutes to submit the data electronically in 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 the purpose, Fusion Technology Solutions is offering Pharmacovigilance Courses. In pharmacovigilance courses, candidates are trained for using different medical devices like heart mapping devices, ultrasound and MRI machines, CT scanners, X ray machines and LASIK machines. Also, clinical trials are also carried on these machines in order to check their accuracy and identifying malfunction occurrences if any. Classification of medical devices is given by US Federal Health government. Medical devices are classified into class 1, class 2 and class 3 type of devices in which class 1 devices denotes low risk of patient health while class 3 devices denotes high risk of patient health. Pharmacovigilance courses in Fusion Technology Solutions are especially set in the manner that clinical researchers will get full study and hands on practical on medical devices. 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 job of Drug Safety Associate (DSA). The role of DSA’s are checking minimum safety information and data reconciliation.

Required skillset 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.

Use of CT scanners in clinical trials are 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 body. LASIK machines are used for collecting data on eye and internal parts of eye for further studies on color blindness, color configuration and retinal imaging of volunteers.

Imaging is very crucial part in clinical trials as cost is rapidly increasing for drug development and characterization of drug efficacy and safety are on the prime position for clinical trials institutes. Study of molecular medicines and genomics is ever growing and expanding array in clinical trials as more discoveries are made every day in medical sciences. Multi- center imaging is standardizing and becoming a crucial part in imaging technology. Image analysis and data acquisition are the key skills required for the purpose. This data is used for post approval stage of medicines/drugs in order to analyze effects of medicines on human body after ingestion. 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-

Phase 1: Giving dose to healthy volunteers for safety.

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

Phase 3: testing medicine and asses effectiveness of medicine.

Phase 4: post marketing survey in public.

Conclusion:

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