Recent Updates That Will Attract New Trials In India

The DCGI (Drug Controller General of India), who is responsible for the approval of licenses of specified categories of drugs, and lays down the standard and quality of manufacturing, selling, import, and distribution of drugs, has brought forward a few changes in the clinical trials rules and regulations, which are sure to attract more and more new trials in India. The alterations and updates made are stated below.

• The turnaround time for approvals of all global clinical trials has been given a deadline of 180 days.
• Instead of just one New Drug Advisory Committee, the approval of new drug clinical trials will be decided upon by the Subject Expert Committee, after which the recommendations will be reviewed by the Technical Review Committee. Finally, it is the Central Drugs Standard Control Organization that will grant approval. This entire procedure will thus decrease the turnaround time of clinical trial approval.
• The Investigator will undertake a maximum of three trials to ensure more accountability and the least possible chances of negligence in clinical trials.
• All individuals subject to trials will be provided with primary care for any kind of illness they experience during their trial participation.
• The last update has been revised over the compensation for trial related injuries, and an order has been released confirming the compensation for trial related injuries or death to be paid to the trial subject or nominee.
• The Phase-I clinical trial is exempted for medical devices, but the procedure for clinical trial approval, accreditations of investigators, ethics committee, sites, and other conditions will remain the same.
• Academic studies will be conducted after approval by the Institutional Ethics Committee, but any new drug or the new usage of an existing drug will require approval of the Drug Controller General of India.
• Any generics of biosimilars that have been marketed in the USA for more than 4 years and have a satisfactory report would be approved for marketing in India after short trials.
• Clinical trial for new drugs that are already approved in other countries can be waived in India if it is for extreme urgency, extreme diseases, or national emergency.
• It two or more countries have removed a drug from the market on the grounds of safety and efficacy, then the continued marketing of the drug in India will be subject to examination and action.
• The SEC will review all the factors that are responsible for deciding if they are ethnically sensitive or insensitive, before giving any clinical trials approval.
• The Central Drugs Standard Control Organization considered that there should be an existing therapy to compare the test drug related to placebo control, to ensure that it is appropriate, efficient, and ethical.
• If the Indian population is participating in global clinical trials, for an indication that is prevalent in India, the sponsor or innovator should market the NCE in an expedited way by manufacturing. This should be confirmed in the form of an application submission.
• The Central Drugs Standard Control Organization requires post-marketing surveillance of drugs, rational use of drugs, adverse drug reactions monitoring, and drug utilization studies, for which is will work with the Indian Council of Medical Research to sponsor the related studies.

With all of these alterations made in the rules and regulations of Indian clinical trial procedures, the country will definitely see a rise in the number of clinical trials being performed here. And with this rise, there will also be a rise in the career opportunities for clinical trial professionals. Join the league and get yourself enrolled with Avigna Clinical Research Institute, one of the top clinical research institutes in Bangalore, which will provide you with the best quality training, along with 100% placement guarantee in the best CROs, pharmaceuticals, and Biotech companies.

Suggested Tags: Why Do People Join Clinical Trails, Why and How Should You Learn Clinical Research, The Past and Present of Clinical Research, What Are The Career Prospects Of Clinical Research In India

What Is Medical Excellence?

The practice of medicine has changed in a huge manner since the past few years. Some of these practices have resulted in great results, while others haven’t matched up to the patients’ expectations. Thus, we need to understand why some practices succeed, while the others fail. There is a divide between reasonable intentions and the reality.

The medical industry has its own set of rules and regulations; and it is important for us all to abide by all these rules and laws. This is a very well-known fact. It is believed that when rules and regulations are followed, it leads to excellence. But, this is not always the case! Now, this statement may have got you into confusion. How can following rules not lead to excellence? When rules are followed, everything is standardized, thus in turn, leading to brilliance, isn't it so? On a general note, yes. But, always, no! Let us explain.

Which Soft Skills Do You Need In A Clinical Research Career?

Clinical research professionals definitely need a legitimate certificate of diploma in clinicalresearch Bangalore from a reputed institution like Avigna Clinical Research Institute. But, along with this, there are certain soft skills that are important in the industry too. And, when you get to learn the course along with getting training for soft skills in the same institute, there can be nothing better! In this blog, we state the most important soft skills that are needed to not only get a job, but sustain it.

Genuineness and consistency

Not only in clinical research, but in every industry, genuineness and consistency is important. If you want all your teammates – juniors, colleagues, and seniors – to greet you with a genuine smile, you need to have these qualities. And, only when you have these qualities within you, can you inspire others to be genuine to you too.

Learning and teaching

Any organization works only because of a team. And, when you work in a team, there are many things that you have to teach those who don’t know how to execute something. Similarly, there may be some things that you may not know. So, while you teach others how to do something, don’t hesitate to learn from others too. Learning and teaching are not only parts of professional life, but personal life too.

Adaptability

Just like everything else, the clinical research industry is also constantly changing, and to sustain oneself in this changing environment, it is important that one can adapt to these changes. And, these changes include changes in the government regulations, changes within the department you work in, changes within your project, or change of your roles and responsibilities. Change is hard, but crucial too.

Collaboration

You must be willing to collaborate with all those who work within the organization, or at least on the project you are working on. The more cooperative you are, the more respect you will earn. The more cooperation within the organization, the more successful it will be.

Consciousness

Consciousness about what you say or do is very important. Clinical research is a very demanding, difficult, and delicate industry. You need to be in complete control and think about what you are saying or doing at every point of time.

Attentiveness

Clinical research is a very intricate industry, where attention to every detail is very crucial. Every detail is very important. Every word said in a meeting, every word written in a report, every detail mentioned by a patient – everything is important.

Listening skills

Listening is absolutely important. Try to give your feedback only after listening to all that the others have to say. This will help you understand what people are saying, and will also give you enough space and respect to speak when it is your turn.

Motivation

Clinical research is a very challenging field. When you face really difficult challenges, don’t get afraid or uncomfortable. Keep your motivation alive, as it is only your passion and motivation that will take you through it.

Planning

Meticulous planning at every stage is important. Put in your efforts to plan your tasks and try to put up convincing and acceptable tasks for others too. As a team, everything needs to be planned as per the time to achieve successful outcomes.

Management

Managing everything that is under your responsibility is important. One mistake in clinical research, and everything can be a mess! So, be very careful with how everything is managed and kept on schedule.

Technology savvy

The clinical research industry is becoming more and more advanced, and is adapting to latest technologies. Thus, you must also be capable of adapting to all the technologies as and when required. Without this, you won't be able to achieve anything in this tech-savvy world.

These are just some of the most important soft skills you need to possess. For understanding and being able to acquire all the required soft skills, you must get enrolled with an institution that can help you with the required training, along with courses for diploma inclinical research Bangalore.