Certified Clinical Research Professional :-  Research is invaluable for advancement of the knowledge in a given discipline and it is the method from which new discoveries are made. It is to seek, investigate, study, explore, examine and inquire about a given subject. Without research there can be no progress. Clinical is relating to the bedside of a patient, his disease, or the observation and treatment of patients  Clinical research is when research methods are applied to the clinical setup

Vietnam is a beautiful, vibrant country known for its graceful boulevards and unbelievably beautiful limestone islands. Apart from its natural beauty Vietnam is also gaining global recognition as a country with high potential for conducting clinical research. Over the years there has been a constant growth in Vietnam’s contribution to science and research globally and the support from local authorities have turned the country into a favorable destination for the conduct of global clinical trials. The clinical research industry is all set to significantly contribute to the nations economy with contract research organizations and pharmaceutical companies strongly supported by clinical research units within hospitals. The need for Clinical Research Training in Vietnam is growing significantly and more and more employers are looking to hire employees with training in clinical research.

Sri Lanka is an emerging market for clinical trial business with some contract research organizations already operational in the country. Although Sri Lanka is getting involved more and more in clinical research, it significantly lacks professionals formally trained in conducting clinical trials. The need for Clinical Research Training in Sri Lanka for medical and life science graduates has been stressed upon by various research papers published by Sri Lankan authors.

Online clinical research education is a sensible option to choose if you wish to enter the multi-billion dollar drug development industry. The pharmaceutical industry is an ever green, growing and evolving industry and some even consider it to be recession free. Given the huge number of advantages of working in the pharmaceutical industry it is sensible to explore career options here, especially in the Research & Development departments and thus online clinical research education can be a big plus for candidates who want to enter the pharmaceutical industry to make a career. Given the huge competition for these positions, drug companies prefer to hire candidates who already have a sense of what they are getting into i.e. the knowledge of the overall drug development process, guidelines, international and local regulations applicable, and other important areas. They also look for qualities such as good communication skills, overall personality, ability to think out-of-the-box etc. This is where people with some education in clinical research gain an extra edge, an advantage over candidates with similar qualifications but without any formal training in clinical research. Having enrolled in an online clinical research education program demonstrates your commitment to a career in drug development and the pharmaceutical industry at large. To know more about online clinical research education and training programs please feel free to visit the following link:

Online Clinical Research Education

Principal Investigators are the main pillars in every clinical trial. The principal investigators hold the overall responsibility for everything that takes place at their site with respect to the clinical trial. They may delegate some of their responsibilities to other qualified and trained research staff but they are still responsible for the overall work that takes place in the trial. Principal investigators conduct the informed consent process with the patient and explain the study in detail, they take care of the study specific visits and conduct procedures such as physical examination, collecting vital sign data, among many other tasks. It is important for a principal investigator to be well versed with the clinical trial protocol and applicable guidelines and regulations such as those of Indian DCGI, US FDA etc in order to successfully conduct the clinical trial.

James Lind Institute offers one of the worlds largest number of specialized online clinical research courses. The courses range from basic diploma programs in clinical research to advanced programs that include pharmacovigilance, medical writing, business development, regulatory affairs, data management etc. James Lind Institutes online training programs are unique and as interactive as classroom programs with online access to faculty and fellow students. Clinical research courses offered by James Lind Institute are conducted in James Lind Institutes online virtual campus that utilizes cutting edge, yet user friendly technology to bring high quality training programs to students across the globe. With presence in many countries such as Canada, Belgium, Saudi Arabia and India, James Lind Institute is one of the largest clinical research training providers. Online clinical research programs conducted by James Lind Institute are highly regarded by the academia and by the clinical research enterprise. Students who complete an online program in clinical research from James Lind Institute can find employment in Pharmaceutical companies, contract research companies, hospitals, private clinics involved in clinical trials, multi-speciality clinics, research centres etc. To know more about clinical research courses conducted by James Lind Institute please click here: Clinical Research Courses

Clinical Trial Project Management is one of the most important functions within a Clinical Operations team. It is equally important for both Pharma-biotech companies conducting their own clinical trials as well as Contract Research Organizations that conduct clinical trials for sponsor companies. Good Project Management results in savings of costs and resources and leads to a high quality end product. Good Project Management results in a clinical trial being conducted smoothly and efficiently without any major problems along the way. It is said that Good Project Management is only as good as the Project Manager. So, it is important to have an experienced Project Manager running the project who knows all the tricks of the trade.

Freelance medical writers often find themselves contracted by sponsors for writing clinical trial reports (CTR) also known as clinical study reports (CSR) even before all the required documentation is ready at the sponsors end. This causes delays in the completion of the clinical study report. In addition, delayed CTR completion can extend the actual submission date of the product’s eCTD/marketing application as clinical study reports are mandatory documents for the regulatory submission dossier. Every day by which the marketing application submission gets delayed, results in a considerable loss of revenue for the sponsor.

Completion of the clinical study report must be taken on a priority after study completion and all efforts must be put in to ensure that a clinical study report is finalized within a reasonable amount of time. This will not only reduce the cost of CSR development but also result in faster submission to the regulatory authorities.

Oracle Clinical is a comprehensive Data Management system developed by Oracle Corporation that provides the clinical research industry with an integrated approach for clinical trial conduct and clinical data management in compliance with 21 CFR part 11. Oracle Clinical maintains and manages the clinical trial conduct starting from planning a research study to preparation of clinical study report (CSR). Oracle Clinical can be considered to be the perfect clinical trial management system for successful conduct of a clinical project.

ICH-GCP guidelines govern the clinical trial conduct and ensure the protection of patient’s safety and well-being and also ensure that the data collected during the course of clinical trial is accurate and of high quality. For every clinical trial taking place at the investigative site, a clinical research coordinator (CRC) is the main line of communication for most of the activities carried out. A CRC performs many activities such as maintaining source documentation, patient follow-up, CRF filling etc.

In case of an oncology study, the Research Nurse (RN), would best suit for the role of a clinical research coordinator role as he/she is experienced in most of the trial procedures being carried out in the wards. The research nurse plays a vital role in maximizing patient recruitment and in making sure that both the trial protocol and GCP guidelines are closely followed by everyone involved in the trial.