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Clinical Research Approaches
Research is always necessary when it comes to healthcare since the high-quality treatment. We have access to today as the result of years of arduous work by researchers. The basis for all medical product discovery and development is laid by clinical research. This module will provide you with an understanding of clinical trial management which include, the evolution of clinical research as well as the path a drug takes from the laboratory to the market.
Drug Approval and Marketing Process
Drugs must be tested for safety and efficacy before being made available to consumers. Pharmacovigilance course, will include (but not limited to) the risk response strategies, safety in pharmaceutical industry, various drug kinds and the laws governing their discovery, approval, manufacture, and marketing by reading about the drug approval, marketing procedures and much more. Drugs are not items that a typical customer purchases. There are rules and norms regarding the use of drugs.
Harmonization Activities
The process of establishing uniform standards for the pharmaceutical industry is known as harmonization. Comparing clinical trial data is challenging since different countries conduct clinical studies using different protocols. This module's advanced principles help you comprehend why it's important to standardize the clinical data management process internationally. Eliminating needless delays in the global development and accessibility of new medications is the primary goal of this approach. Standard operating procedures in clinical trials and laid protocol helps in this direction.
Scientific Community - Roles & Responsibilities
The ethical and regulatory compliance of human trials is contingent upon the efforts of all research participants, each of whom is a key player in the process. The primary players in the research team are described in detail in this module of clinical research & regulatory affairs. By comprehending this subject, you will be able to apply for jobs in marketing, regulatory affairs, and pharmacovigilance in the pharmaceutical research and development business.
Clinical Trial Documents
In any clinical trial proper collection and storage of study data and other relevant clinical trial information is vital for accurate records. The trial documentation is a legal requirement which is relevant to all trials. It helps to reconstruct the trial as it happened and to evaluate the trial. This module will give you a thorough understanding of good documentation practices which will help to ensure the success of the study at the clinical trial site.
Clinical Trial Protocol & Design
It is crucial to examine and critically assess the study's results using a well-written clinical trial protocol and a well-defined clinical trial design in which the entire clinical trial process is succinctly summarized. A series of protocols or actions that must be taken in order to complete the clinical study are outlined in this module. The significance of comprehending the procedures involved in creating a clinical research/clinical trial protocol is highlighted in this session as a means of conducting a suitable study and producing accurate findings.
Regulatory Authorities World-Wide
To guarantee the efficacy and safety of pharmaceuticals, clinical trials must be controlled. Every nation has an organization under its own government that oversees healthcare products. Regulatory agencies have a crucial role in ensuring the quality, safety, and efficacy of medications that are made available to the general population. Regulatory affairs certification is mandatory to market a pharma formulation. Completing this module will enable students to understand how regulatory agencies including the agency involved in drug regulatory affairs contribute to the public's access to safer and more effective medications
Clinical Data Management
Clinical Data Management (CDM) is a vital stage in clinical research protocol that results in high-quality, reliable, and statistically sound data from clinical trials. This course thoroughly explains the process involved in CDM that includes Case Report Form (CRF) design, database design, data entry and validation, discrepancy management, medical coding, database reconciliation, query creation, and database locking procedures. This course is designed to teach life science/health science graduates how to manage and report huge amounts of clinical data technically and scientifically and finally, database reconciliation. This understanding of various CDM processes will undoubtedly assist learners in working with various CDM software provided by various organizations.
Pharmacovigilance
Without Pharmacovigilance, clinical research cannot be accomplished since drug safety monitoring is the foundation for keeping a society safe and healthy. Pharmacovigilance is a scientific discipline that focuses on detecting, validating, quantifying, assessing, and improving drug safety. The key activities in Pharmacovigilance include delivering end-to-end medical, safety, and analytical services such as medical review, causality assessment, case narratives and processing, and adverse drug reaction prevention with the involvement of regulatory authority. The Pharmacovigilance course covers all of these topics, with an emphasis on reporting systems and various ADR forms, causality assessment, case narration, risk management plans, and various pharmacovigilance programs. This course will provide you a solid understanding of the pharmacovigilance process and operations. Our curriculum is completely industry‑specific and appropriate to applicants from both within and outside the pharmaceutical industry who want to be a part of the pharmacovigilance sector.
Good Clinical Practices
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects. It aims to ensure the protection of participants' rights, safety, and well-being, as well as the credibility and reliability of trial results. This course helps the learners to understand the principles of clinical practices and its application in clinical trials.
Regulatory Affairs
Regulatory Affairs courses deals with the regulatory requirements necessary for the development, approval, and marketing of pharmaceuticals, medical devices, biologics, and other health-related products. This course in Regulatory Affairs cover a broad range of topics to equip professionals with the knowledge and skills needed to navigate the complex regulatory landscape.
Narrative Writing
This course in narrative writing typically covers the skills and knowledge necessary to effectively communicate adverse drug reactions (ADRs) and other safety-related information in a clear and comprehensive manner in healthcare communication. It aims to equip participants with narrative competence necessary to document and communicate safety information accurately and comprehensively. The narrative writing skill is crucial for maintaining public safety, supporting regulatory compliance, and contributing to the ongoing monitoring of the safety profile of pharmaceutical products.
Medical Coding
Medical coding classes in this course aims to equip students with the skills and knowledge needed to accurately code medical information in a standardized manner. This proficiency is crucial for maintaining consistency in adverse event reporting, supporting regulatory compliance, and facilitating communication within the pharmaceutical and healthcare industries.
True Lessons: The perfect blend of specialized courses. Life Sciences, Healthcare, Research and Career Development through integrated language training.
Our Accomplishments
Students' Testimonial
Talking about placements, here's what our dear students have to say about their own experiences with True Lessons.
Dr. Shruti B.R.
“I wanted to take up an academic course in Clinical Research after learning about the scope it entails. But the question persisted; Where from? I finally breathed a sigh of relief after landing in "ACRI (now True Lessons)"! The amazing staff at the institute is the reason I got to interview with leading companies and I’m happy to be placed in a top pharmaceutical company as a Drug Safety Associate. Grateful to the wonderful people at "ACRI (now True Lessons)"!”
Sreelakshmi Sathyakumar
“I joined "ACRI (now True Lessons)" after completing my Bachelor’s in Biotechnology. I felt a pressing need to gather the right technical knowledge prior to joining the industry. Hence, I joined the PG Diploma course in Clinical Research. I have to say, it was truly one of my best decisions as I got placed in Accenture with the wonderful placement support of the institute.”
Purnima H.D.
“Having joined "ACRI (now True Lessons)" in 2018, I have been subject to a myriad of learning opportunities at the institute. The staff at "ACRI (now True Lessons)" were always supportive throughout my journey at the institute. All the technical sessions coupled with the PD ones really opened the right gates for me. It is because of the institute’s endeavour to provide excellent clinical research education that I got placed at IQVIA. I would recommend "ACRI (now True Lessons)" 10/10 for anyone that wants to carve a niche for themselves in the clinical research space.”
Dr. Anupama A Sattigeri
“"ACRI (now True Lessons)" is the perfect institute for aspirants of Life Sciences, Healthcare and Clinical Research looking to further their careers in the field. The courses offered at "ACRI (now True Lessons)" are comprehensive and affordable. The staff, study material and overall conduct of the institution is what makes "ACRI (now True Lessons)" an ideal learning centre. Before joining "True Lessons", I had been to a couple of Clinical Research institutes only to see minimal infrastructure and training staff at the time of my visit. I highly recommend "ACRI (now True Lessons)" as I have gotten placed in one of the best companies with a handsome package.”
Vyshnavi M.
“"ACRI (now True Lessons)" is without a doubt the ideal institute to enhance one’s path in the clinical research field. Having opted for the three-months course, I got to learn a great deal and the four modules were perfectly segmented. Personality development sessions gave my confidence an instant boost and the aptitude tests prepared me to tackle tricky maths. These efforts of the institutes combined by mine led me to be placed at Parexel, a leading CRO. "True Lessons" has given me the best learning experience and I would suggest any aspirant planning to take up careers in Clinical Research to give "ACRI (now True Lessons)" a shot.”
