clinicalresearchinfo8

Top Guidance Tips for CLINICAL RESEARCH Freshers

Amaan Ansari COMPLETED B PHARM FROM NORTH MAHARASHTRA UNIVERSITY, HAVING 3.5+ YEARS OF EXPERIENCE IN CLINICAL DATA MANAGEMENTON A PERSONAL FRONT, I AM KEEN TO HELP AND GUIDE INDIVIDUALS IN CLINICAL DATA MANAGEMENT AND PHARMACOVIGILANCE.ALSO ON GENERAL ASPECTS SUCH AS COMMUNICATION SKILLS, INTERPERSONAL SKILLS, INTERVIEW TIPS, RESUME WRITING, EMAIL WRITING. This content is copied from Amaan Ansari’s LinkedIn posts. Please read the post carefully as Amaan gave some light to a particular topic. Many Life Sciences graduates/postgraduates also Pharm graduates/post graduates especially freshers are looking for opportunities in #clinicaldatamanagement and #pharmacovigilance etc. For entering these fields many individuals are additionally pursuing PG Diploma in CDM and PV and investing thousands of rupees in it. The question here is, are these certificates compulsory to enter these fields?The answer is “No”. If you are pursuing it’s good but it’s not compulsory for entering PV or CDM. As a fresher you just need to:1) Be thorough with your educational background.2) Develop communication skills.3) Gain basic knowledge of CDM and PV through Slide Share ppt, Google ppts. etc.4) Prepare a good CV5)Approach people working in PV and CDM for professional guidance. Remember one or the other day you will be selected. If you are rejected anywhere there is always a better opportunity waiting for you. The majority of Pharmacy and Life Sciences freshers are confused about how to start their careers. How to start your career Below are some important points: If a person is posting any job opportunities from his/her organization it is always as a helping hand. A person will post whatever official email he gets from his organization let it be for freshers/ experience. He can’t post anything from his end. Also if you are eligible for the particular job role the most he/she can do is Refer you and guide you, that’s it what we can do. Getting interview calls and getting selected is not in our hands. I know as a fresher it’s not easy to get a chance. But have faith in yourself and prepare yourself and be the best, hopefully, One day you will get your dream job. So keep learning and Helping each other. I try to reply to every person who DMs me, sometimes due to an overload of DMs there might be a delay in reply, but I assure you that I reply. Please note this is a generic scenario. It may vary from person to person.vI applied for many jobs but no response!! There is always a common question among freshers that we are applying for many job opportunities for the last 5/6 months but we are not getting any calls. Below may be some of the reasons. Please remember there will always be a position that suits your profile, you have to just look for it, read the job eligibility and job description properly, and apply for it. Job openings on the company portal The below topic is regarding applications for job openings on the company portal. Below are some key points: Email Writing There is a common question among #freshers that we are emailing #cvs to many people but then to we are not getting any calls. Below are some reasons: Please note that A Proper email with a good #subjectline#body#cv is always appreciable. Telephonic/Virtual Interview Below the topic is a Telephonic Round of Interviews with #hr Many of us are waiting for getting calls from #recruiters, the question here is are we ready for it. Below are some key points regarding HR interview calls: Hopefully the above would help all. Interview in CDM Below are some basic topics that you need to be prepared for if you are looking to make your career in #clinicaldatamanagement. # Finally and Most Important-Basic Info of Organization you are looking for. -Establishment year -Number of Employees -CEO of Organization etc. -Mision and Vision of the Organization. Why do you want to work in Our Organization.-Why should we hire you.-Where do you see yourself after 5 years.-What are your career goals. All other basic Aptitude questions. Guidance to check the authenticity of job posts on LinkedIn Are all Job Openings posted for freshers Correct or its Fake? Always remember to review a person’s profile before commenting on his/her post or sending him/ her a connection request. Nowadays it’s been observed that people working in a particular organization are posting Job openings of some other organizations and posting just that ” DM me or Inbox me for details”. Think twice if a person is not in that Organisation He/ She can’t give you details and can’t refer you to that organisation. Such kinds of posts are just for making connections and misguiding people. But! If a person is posting some other organization’s openings and giving you a link to apply which is directing you to that organization’s page then no issues in such cases. Interview in PV This topic is #interview in #pharmacovigilance#pv Below are some basic topics that you need to be prepared if you are looking to make your career in #pharmacovigilance#pv Technical Round(Face-to-Face) Most Important Pharmacology in detail (Basic Info of All Classes of Drugs, MOA, Classification etc) The Basic Info of the Organization you are looking for. All other basic Aptitude questions. Which domain has a Good Career for Pharmacy or Life Science graduates post graduates? There are many questions in the minds of freshers regarding their Careers. Q1) Which field has better growth? Answer- Growth always depends on personal skills, knowledge, and quality of work. It is independent of the Field. You should always be the best in your field. Q2)Which field has a better package? Answer- The package depends on many factors. It also depends on Personal skills, Domain related experience, and knowledge. All domain has equal package offer. Q3) Which field has less workload etc.? Answer- There is workload everywhere and No workload anywhere. It’s totally dependent on the individual to balance and handle it. It is independent of any domain or company. Q4) Which field is more interesting? Answer- Choose a field in which you are good and whatever is your passion. Working in a domain in that you

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Applicant Tracking System (ATS)

Aman, a pharmacy graduate, discovered an ideal job opening that aligned with his qualifications. He meticulously prepared a comprehensive resume, accompanied by a cover letter, and submitted his application through a job portal or company website, eagerly awaiting an interview invitation. However, an unexpected hurdle arose. Despite his qualifications, Aman didn’t receive an interview call, leaving him bewildered. This scenario is not unique to Aman; it’s a widespread issue affecting many students and professionals in life sciences, pharmacy, and pharmacology. The root cause of this challenge is often the Applicant Tracking System (ATS). Many job seekers are unaware that approximately 75% of job applications are discarded by ATS before they even reach a recruiter. These systems might be obstructing your path to your dream job. Let me give you a brief idea of what you need to know about applicant tracking systems,  and what you can do to optimize your resume and beat these bots. Before moving ahead, let’s understand below flow process; Here’s what you need to know about ATS and how to optimize your resume to surpass these digital gatekeepers. What is an Applicant Tracking System (ATS)? An ATS is a software tool used by employers and recruiters to manage the hiring process. It scans, sorts, and ranks job applications for open positions, streamlining the recruitment process. Functioning of Applicant Tracking Systems ATS acts as an electronic gatekeeper. It scans resumes for specific keywords to decide if an application should progress to the recruiter. It filters out unqualified candidates, allowing recruiters to focus on potential matches for the position. Unfortunately, resumes not tailored for ATS, even from qualified candidates, may be overlooked. Writing an ATS-Friendly Resume To ensure your resume is ATS-compatible, focus on incorporating relevant keywords and selecting the right file type. Testing Your Resume for ATS Compatibility Different ATS Systems Several ATS platforms exist, each with unique features. Some well-known ones include Taleo, Workday, SuccessFactors, and Greenhouse. Large pharmaceutical companies and CROs commonly use ATS, as do job portals like Indeed and LinkedIn. To enhance the chances of your resume passing through Applicant Tracking Systems (ATS), you can use various free online tools designed to check ATS compatibility. Here are some notable options: These tools can be very helpful in tailoring your resume to specific job postings and ensuring that it is ATS-friendly. However, it’s important to remember that while these tools provide valuable insights, they may not capture every nuance of an ATS. Therefore, it’s a good idea to use these tools as part of a broader strategy, including getting feedback from career counselors or industry professionals. Understanding and adapting to the intricacies of ATS can significantly enhance your job application’s success rate. Remember, it’s not just about your qualifications but also how you present them in an ATS-friendly manner. Tags: Applicant Tracking System, ATS Software, Clinical Research, Clinical Trials, Overcoming ATS, Job Application, Recruitment Process, Talent Acquisition Platform.

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Resume Preparation and Job Application Guidance – Clinical Trial

Hello! A well-written resume or CV significantly impacts your job hunt. Although I’m not a resume review expert, I guide freshers and professionals based on my experience in clinical research and understanding of recruiters’ requirements. My analysis covers skills, introduction, grammar, powerful language format, target domains (CRC, CRA, CDM, PV, MW, or BIO-STATISTICS), recruiter requirements, summary content, proofreading, ATS system, and additional tips. I am in contact with over 500 freshers from life sciences, B.Pharm, B.Sc., M.Sc., M.Pharm, and Pharm D backgrounds. During discussions, questions about resume preparation and job applications frequently arise. To address these questions en masse, I decided to write this article, hoping it adds value to your career. Here, I’ve listed steps to create an impressive fresher resume: The sooner you begin, the better for landing your first job. Tip 1: Select a Suitable Resume Type Choose a resume type relevant to your situation. There are various formats, such as chronological, functional, and combination resumes. Chronological resumes are suitable for candidates with extensive experience, listing recent work at the top. However, freshers should focus on skills rather than experience, making the functional resume a better choice. Online templates can help you build a winning resume. Tip 2: Write an Impressive Headline Your resume’s headline should summarize your career objectives and academics in two or three lines. A concise, professional headline makes you stand out. Incorporate keywords from the job description to make it appealing and relevant. Sample fresher resume headline: “Keen on understanding and quickly learning study protocols and concepts. Knowledgeable in the basics of clinical research and designs. Capable of collaborating with senior members to meet timelines. Tip 3: Ensure Readability Use legible fonts like Calibri, Arial, or Times New Roman at a size that is neither too small nor too big (ideally size 12) for your fresher resume. Use bullet points for key information to make it stand out. Tip 4: Add Relevant Keywords Optimize your resume with job-related keywords for easy scanning by Applicant Tracking Systems (ATS). Read job descriptions carefully to identify appropriate keywords. Tip 5: Highlight Key Projects and Achievements For freshers, highlighting academic achievements, projects, and extracurricular activities is crucial. Include internships, awards, and volunteer activities to add value to your CV. Tip 6: Proofread Your Resume Imagine a recruiter’s reaction to a CV with grammatical or typographical errors. It’s vital to proofread your resume to avoid giving a bad impression. Create an error-free resume with Firstnaukri’s free Resume Maker Tool, designed for freshers. Remember, recruiters call for interviews based on your resume. A CV should include: Remember to tailor your CV to the job application. If you’re unsure about the target domain, prepare separate CVs for each. Research Experience (CRC) Skills, CTA Skills, CRA Skills, Clinical Data Management, Biostatistics, and Pharmacovigilance Skills are detailed. Job Application Process: Write a compelling email when sharing your CV with HR. Here are two email templates for job applications. Email to HR Job Application Email Template 1 Subject: Name of Applicant – Name of Position, Job Reference Number Dear Mr./Ms. Last Name, I came across a very _______ position on your job portal that I believe fits me perfectly. I am interested in applying for the position of _________(Job Reference Number 123) at _____________. After reading the job description and requirements and matching it with my own knowledge, I know that I would be a valuable asset to your organization. I recently graduated with a Bachelor of ___________from the University of_____. I now want to apply my skills in a multinational company like _____ (Company). As a ______(profile name), I can implement knowledge in clinical research domain. I have attached a cover letter, resume, and certificates for your consideration. Please take a moment to go through them to get a better picture of who I am. I would love to talk to you in more detail regarding this amazing opportunity at your company. It would give me great pleasure to hear back from you regarding my application. Sincerely, Your Name Your Address Your Phone Number Your Email Address Job Application Email Template 2 Subject: Your Name– Job Title, Job Reference Number (mentioned in Job Description) Dear Mr./Ms. Hiring Manager’s, Name I am writing to apply for a recent job opening advertised on your website for the position of ‘___________. The position and responsibilities seem exciting and matching to my interest areas and career goals. I would like to bring your attention to my key strengths for the job role: ## Bachelor of ______ ## Strong command in _________(Skills) ## Interest and knowledge of ______ For more information, I have attached my cover letter and resume for your consideration. Thank you for your valuable time. I am always reachable on my email and phone number. Sincerely, Your Name Contact Number Email Address Wrap-Up Invest time in preparing a potent CV rather than applying randomly to numerous jobs. Below are some resume websites for assistance: For further guidance or queries, connect with me on LinkedIn. All the best! Content: Shahenaz Karadesai

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Contract research organizations in India

Contract research organizations (CROs) provide/serve specialized clinical trial services and other research support services for the pharmaceutical, biotechnology, and medical device industries and also serve government institutions, foundations, and universities. One of the main reasons why organizations and businesses that enter into a contract with CROs, do so is to acquire specific expertise without the need for hiring permanent staff and hence save employee costs and time. A contract/clinical research organization is extending such a helping hand in biopharmaceutical development, clinical research endeavors, clinical trial conduct, product commercialization, biologic assay development, and pharmacovigilance. A contract with an outside company means that the hiring organization does not need the infrastructure, office space or manpower to run these trials themselves. and they save time from getting into the direct job recruitment process. Some CROs manage almost all aspects of a clinical trial, from site selection and patient enrollment through final regulatory approval from the Food and Drug Administration and European Medicines Agency. Although a trial sponsor may transfer all trial functions to a third-party CRO, the sponsor remains responsible for the integrity of the trial data and for ensuring it is all factual and backed by good science. As pharmaceutical companies and medical device organizations face increasing pressure on high drug costs, they are looking for ways to lower prescription drug costs without losing profits. Outsourcing clinical trial management is a way for these companies to significantly lower overhead costs, helping them make up for the dollars lost for lower medication prices.  Types of Services Provided by CROs Contract research organizations offer comprehensive services, including: These are some of the top and best list of CRO’s in India: ACM Global Laboratories Since 1975, ACM Global Laboratories has been a recognized leader in both medical diagnosis and global clinical trial testing services. With facilities wholly owned in New York, England, Shanghai China, Mumbai India, and Singapore. Accenture Achieving meaningful results for our clients through inspiring thinking and transformational vision, Accenture in India offers a wide range of services spanning strategy, consulting, digital, technology and operations. Accutest Global Accutest is an independent and internationally accredited Contract Research Organization (“CRO”) founded in 1998. Offering services to customers worldwide and operations in India, throughout Asia, and Brazil. Aagami Aagami, Inc. Is a life science consulting firm headquartered in the suburbs of Chicago that provides strategic advisory services and business development support in areas that are inaccessible to you because of its bandwidth technology licensing services. Asiatic Clinical Research Asiatic Clinical Research is a clinical research organization (CRO) headquartered in Bangalore, India. Focus on Phase II-IV clinical trial support for pharmaceutical, biotech, and medical device companies. APCER Life Sciences APCER Life Sciences is committed to omprovise health in partnership with their clients. They bring together safety-medical, regulatory, and technology resources. Actimus Bio Actimus Biosciences is a knowledge based CRO which was established in the year 2005. The facilities are located in Visakhapatnam, Andhra Pradesh, India. Accelsiors Accelsiors is a CRO committed to serving its Sponsors with the highest level of quality. They provide a full array of services and pride in having ready access to treatment-naive patient populations. AXIS Clinicals AXIS is a metric based clinical research organization with a global footprint of operations. Representing a vertically integrated CRO, they provide a collaborative approach to meet sponsor study requirements. Bio Reliance Corporation BioReliance provides manufacturing and testing services to pharmaceutical and biopharmaceutical companies that span the product cycle from early pre-clinical development to licensed production. Bio Axis Started in 2005 Bio axis DNA Research Centre (BDRC) private limited is a top level CRO in life sciences with a vast range of services in Biotechnology, Bioinformatics, Forensic Science and Clinical Research. Catalyst Clinical Services Focus area of Catalyst is Clinical Trials Management and Execution, Medical Writing, Independent Auditing and Clinical Research Training. Cliantha Research Cliantha Research is a full-service Clinical Research Organization (CRO) based in Ahmedabad, Delhi and Mumbai. CliniRx CliniRx is a full-service, mid-size CRO that provides end- to- end solutions for clinical studies. CliniRx’s services include Phase II –III and late Phase (Phase IV) across numerous therapeutic areas and specialities. Covance Covance Inc.,is a global contract research organization (CRO), is the world’s most comprehensive drug development and research company. Dishman Group Dishman is the global outsourcing partner for the pharmaceutical industry offering a portfolio of development, scale-up and manufacturing service. Divi’s Laboratories Limited Divi’s has been established for 29 years in Hyderabad, India with two manufacturing units and is among the top pharmaceutical companies in India. Divi’s is known as a ‘Reliable Supplier of generic APIs (Active pharmaceuticals ingredients)’ and a trustworthy ‘Custom Manufacturer’ to Big Pharma and also is among the top API manufacturers in the world. Dubar Research Foundation Dubar Research Foundation (DRF) is an Indian Contract Research Organization offering pre-clinical services in Drug Discovery and Development, ranging from identification of potential lead molecules, and drug development to IND-enabling studies. Endpoint The endpoint is the destination for people who are passionate about the most innovative and high-quality IRT solutions for clinical trials. Eurofins Advinus Eurofins Advinus is R&D service that supports the discovery and development of compounds for diverse industries including Pharmaceuticals, Biologicals, Agrochemicals, Nutraceuticals and Cosmetics. Fountain Medical Development (FMD) FMD K&L is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries. GCT (Global Clinical Trials) A full-service clinical development service provider, offering feasibility, regulatory submission, site selection, project management, monitoring, data management, logistics, and more. GVK Biosciences GVK BIO, a Contract Research & Development Organization – CRDO that services the global Biopharma industry; is headquartered in Hyderabad, India with operations in four sites including California, USA. Global Drug Development Experts (GDDE) Global Drug Development (GDD) Experts is the Site Management Organization (SMO) in India. Hi Tech Bio Laboratories  Hi Tech BioSciences India Ltd. is a supplier of high end products and research-based solutions in the arena of nutraceuticals and biocatalysis.

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What is ALCOA and ALCOA+

ALCOA and ALCOA+ refer to a set of principles essential in ensuring the integrity and quality of data, particularly in scientific and regulatory environments. Initially, ALCOA stood for five key attributes: Attributability, Legibility, Contemporaneity, Originality, and Accuracy. These principles are foundational in ensuring that data is reliable and trustworthy. These core principles were later expanded to form ALCOA+, adding four additional concepts: Completeness, Consistency, Endurance, and Availability. These principles collectively ensure the integrity, reliability, and traceability of data, making them fundamental in fields that demand high standards of documentation and data management.

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The History, Present, and Future of Clinical Trials

Ever wonder about clinical trial history? Here is a riposte. My career journey started in 2014 as a trainee in clinical research, and since then I eager to know its basics. Not book basics but the practical scenario and evolution of clinical trials. My mind was popping up with questions like Which trial was first conducted? Which study design was conducted 1st? What is the pre-James era? How do clinical trials evolve from traditional to EDC and decentralized clinical trials? If you also want to know, read ahead! I thought to write about the history in detail but all contents are available on the internet and easily accessible, hence I am covering and linking all the relevant articles here. The concepts behind clinical trials are interesting. The first unofficial clinical trial can be traced back to biblical times when a king tracked the effects of different diets on his subjects. More than two millennia ago, the Greek physician Hippocrates stressed that a competent researcher must ensure that his starting point is knowledge of what has already been discovered. The Book of Daniel chapter 1, verses 12 through 15, for instance, describes a planned experiment with both baseline and follow-up observations of two groups who either partook of or did not partake of, “the King’s meat” over a trial period of ten days. Persian physician Avicenna, in The Canon of Medicine (1025) gave similar advice for determining the efficacy of medical drugs and substances. A lot to know in detail about the clinical trial history and James Lind Library did the lion’s share of the work. The James Lind Library collects historic cases related to clinical trials and has developed fantastic resources to explain the importance and elements of the conduction of clinical trials. The James Lind Library (www.jameslindlibrary.org) has been established to improve the public and professional general knowledge about fair tests of treatments in healthcare and their history. Its foundation was laid ten years ago at the Royal College of Physicians of Edinburgh, and its administrative center is in the College’s Sibbald Library, one of the most important collections of historic medical manuscripts, papers, and books in the world. The James Lind Library is a website that introduces visitors to the principles of fair tests of treatments, with a series of short, illustrated essays, which are currently available in English, Arabic, Chinese, French, Portuguese, Russian, and Spanish. A 100-page book– Testing Treatments–is now available free through the website, both in English and in Arabic and Spanish translations. To illustrate the evolution of ideas related to fair tests of treatments from 2000 BC to the present, the James Lind Library contains key passages and images from manuscripts, books, and journal articles, many of them accompanied by commentaries, biographies, portraits and other relevant documents and images, including audio and video files. New material is being added to the website continuously, as relevant new records are identified and as methods for testing treatments evolve. A multinational, multilingual editorial team oversees the development of the website, which currently receives tens of thousands of visitors every month. I would suggest visiting the website once and enjoying the ride from Hippocrate 500 BCE to date journey. Aeroplane View of History I am linking all the articles of https://www.veristat.com. You can click on the below link to read in detail. 1700-1800: The History of Clinical Research: 1700’s & 1800’s 1900-1930: The History of Clinical Research: 1900 – 1930 1930-1950: The History of Clinical Research: 1930 – 1950 1950-1980: The History of Clinical Research: 1950 – 1980 Historic cases related to clinical trials (Thejameslindlibrary.org) Hippocrates (5th century BCE) al-Razi (10th century CE; 4th century AH) Ibn Sīnā (c.1012 CE; c.402 AH) Bacon, Roger (1266) Petrarca F (14th century) 562 BC – 1537: Pre-James Lind Era As per the NCBI article of @DR. Arun Bhatt “Evolution of Clinical Research: A History Before and Beyond James Lind”, The world’s first clinical trial is recorded in the “Book of Daniel” in The Bible. This experiment resembling a clinical trial was not conducted by a medical, but by King Nebuchadnezzar a resourceful military leader. This experiment is well explained in “Legumes, lemons, and streptomycin: A short history of the clinical trial.” From this trial, we understood the initiation of open-labeled groups. Paré A (1575) Hidalgo de Agüero, Bartolomé (1604) Bacon F (1645) Van Helmont JB (1648) Nettleton T (1722) Clifton F (1732) Cheselden W (1740) Lind J (1753) 1747: James Lind and Scurvy Trial James Lind was a Scottish doctor and considered the first physician to have conducted a controlled clinical trial of the modern era. Cullen W (1772) Millar J (1779) Mesmer FA (1781) Alanson E (1782) Commission Royale. Bailly A (1784) Black W (1788) Sutton D (1796) Haygarth J (1800) 1800: Arrival of Placebo (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149409/) It took another century before the emergence of another important mile stone in the history of modern clinical trial: the placebo. The word placebo first appeared in medical literature in the early 1800s. Hooper’s Medical Dictionary of 1811 defined it as “an epithet given to any medicine more to please than benefit the patient.” However, it was only in 1863 that United States physician Austin Flint planned the first clinical study comparing a dummy remedy to an active treatment. He treated 13 patients suffering from rheumatism with an herbal extract which was advised instead of an established remedy. In 1886, Flint described the study in his book A Treatise on the Principles and Practice of Medicine. “This was given regularly and became well known in my wards as the ‘placeboic remedy’ for rheumatism. The favorable progress of the cases was such as to secure for the remedy generally the entire confidence of the patients.” Cooper A (1801) Percival T (1803) Lesassier Hamilton A (1816) Hawkins FB (1829) Löhner G, on behalf of a Society of Truth-loving Men (1835) Louis PCA (1835) Gavarret LDJ (1840) Forbes J (1846) Tessier JP (1852) Balfour TG (1854) Semmelweis I (1861) Kocher T (1883) Rayleigh, The Lord (1885) Bettencourt R, Serrano J-A (1891) Vorderman AG (1897) Fibiger J (1898) Haffkine WM (1900) Celli A (1900) Choksy NH (1900) Park WH (1900) Lustig A, Galeotti G

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CTRI

CTRI – Clinical Trial Registry of India

The Importance of Registering Clinical Trials in the Clinical Trial Registry of India The Clinical Trial Registry of India (CTRI) is a free and online public record registry owned and hosted at the ICMR’s National Institute of Medical Statistics. It was launched on July 20th, 2007, and serves as a crucial platform for registering all clinical trials conducted in India. Initially, the registration with CTRI was voluntary. However, from June 15th, 2009, the Drugs Controller General (India) (DCGI) made it mandatory for all clinical trials conducted in India to be registered with CTRI. This move was further supported by 11 major journals in India, which declared that only registered trials would be considered for publication. The CTRI, available at www.ctri.nic.in, is an online, free, and searchable system that allows prospective registration of all clinical studies being conducted in India. It also serves as a registry for clinical studies conducted in countries that do not have their own primary registry. Any researcher, sponsor, investigator, or institute planning to conduct a clinical trial involving human participants in India is expected to register the trial in the CTRI before enrolling the first participant. This requirement extends to trials involving interventions such as drugs, surgical procedures, educational or behavioral treatments, preventive measures, lifestyle modifications, devices, rehabilitation strategies, as well as trials falling under the purview of the Department of AYUSH. By registering clinical trials in the CTRI, several benefits are realized: Transparency and Accountability Registration in the CTRI promotes transparency and accountability in clinical research. It allows researchers, regulatory bodies, and the public to access information about ongoing and completed trials, including study protocols, participant recruitment status, and outcomes. This transparency helps prevent duplication of trials, fosters collaboration, and ensures that research findings are disseminated. Ethical Considerations CTRI registration ensures that trials are conducted ethically and in compliance with regulatory guidelines. It helps prevent unethical practices such as selective publication of results, outcome switching, or non-disclosure of trials with unfavorable outcomes. By making trial information publicly available, it encourages responsible research conduct and protects the rights and welfare of study participants. Improved Research Quality CTRI registration enhances the overall quality of clinical research by facilitating better study design and reducing research waste. Researchers can access information about similar trials, ongoing studies, and relevant outcomes, enabling them to design studies that address existing knowledge gaps effectively. Additionally, by registering trial protocols, the risk of outcome reporting bias is minimized, leading to more accurate and reliable research findings. Facilitating Collaboration and Knowledge Exchange The CTRI serves as a platform for researchers and sponsors to identify potential collaborators, share ideas, and exchange knowledge. By providing a comprehensive database of registered trials, it enables researchers to explore existing research in their field and avoid unnecessary duplication. This collaborative environment fosters innovation, accelerates research progress, and ultimately benefits patients and healthcare systems. Promoting Public Trust Registration in the CTRI helps build public trust in clinical research. By making trial information accessible to the public, it allows individuals to make informed decisions about participating in trials. It also demonstrates the commitment of researchers and sponsors to transparency and accountability, which are vital for maintaining public confidence in the research process. To find out the Trials on CTRI website, follow the below steps; In conclusion, the Clinical Trial Registry of India (CTRI) plays a crucial role in promoting transparency, accountability, and ethical conduct in clinical research. By making trial information publicly available, it enhances research quality, facilitates collaboration, and builds public trust. It is imperative for all researchers, sponsors, investigators, and institutes conducting clinical trials in India to register their trials in the CTRI, ensuring the integrity and advancement of clinical research in the country.

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The Future of Clinical Research Management: Trends, Challenges, and Opportunities

The Future of Clinical Research Management: Trends, Challenges, and Opportunities

Delve into the evolving world of clinical research management with our insightful blog post. Discover the latest trends shaping this dynamic field, from groundbreaking technological advancements to patient-centric trial designs. Learn about the critical phases of clinical research, the impact of digital transformation, and the future career opportunities in this fast-paced industry. Whether you’re a healthcare professional, a budding researcher, or simply curious about the future of medical science, this post offers a comprehensive overview of the challenges and opportunities ahead in clinical research management

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Understanding the Various Departments in Clinical Research: Roles, Workflows, and More

Understanding the Various Departments in Clinical Research: Roles, Workflows, and More

Welcome to our deep dive into the world of clinical research! Whether you’re a budding professional, a curious student, or simply someone interested in the inner workings of this field, this blog post is designed to give you a clear understanding of the different departments involved in clinical research, their roles, workflows, and how they all come together to push the boundaries of medical science. 1. Medical Writing 2. Clinical Operations 3. Data Management 4. Risk-Based Monitoring 5. Regulatory Submission Unit (RSU) 6. Pharmacovigilance (PV) Team 7. Statistics Team 8. Project Management Team 9. Quality Assurance Conclusion: We are at the end of Various Departments in Clinical Research articles. In the dynamic and interdisciplinary world of clinical research, each department plays a pivotal role. Understanding these roles not only provides insights into how new medical therapies are developed but also highlights the collaborative nature of this field. We hope this overview sparks your interest in the fascinating world of clinical research!

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Drug Development Process

Drug Development Process

The drug development process is a complex and multi-phase procedure that pharmaceutical companies follow to discover and bring a new drug to market. This process can be broadly divided into several key stages: Discovery and Development: This phase involves extensive research to identify new drugs and understand their mechanisms. Scientists conduct experiments to discover and refine potential drug compounds. This phase includes: Preclinical Research: Before testing the drug in humans, researchers must perform preclinical studies to gather data on the drug’s safety and efficacy. This usually involves laboratory and animal studies to determine if the drug is safe to test in humans and to predict how it might behave in the human body. Clinical Trials: This phase involves testing the drug in humans and is divided into three phases: FDA Review and Approval: Once the clinical trial phases are complete, the sponsors submit a New Drug Application (NDA) to the Food and Drug Administration (FDA). The FDA reviews the data from the trials and decides whether to approve the drug for use. Post-Market Surveillance: After a drug is approved and on the market, it is subject to ongoing monitoring to ensure continued safety in the general population. This phase may involve additional studies, including Phase IV trials, and ongoing reporting of adverse effects. Patenting and Exclusivity: Throughout the process, drug developers often seek patent protection and exclusivity rights for their new compounds, which grants them a temporary monopoly on the sale of the drug to recover the costs associated with its development. This process is generally lengthy and expensive. Furthermore, it is subject to strict regulation and oversight, ensuring that new drugs are both safe and effective for public useIt often takes many years from the discovery of a new drug to its availability on the market. An illustrative example The drug development process is the creation and approval of a drug called Sovaldi (sofosbuvir), used for the treatment of hepatitis C. This example encapsulates the key stages of drug development: Sovaldi’s development journey is a typical example of the rigorous and multi-step process involved in bringing a new drug from the laboratory to the market, ensuring it is both safe and effective for patient use. Stage Activity Description Discovery & Development Target Identification Identification of the hepatitis C virus and its RNA polymerase as targets. Lead Compound Identification Discovery of sofosbuvir, a compound that inhibits HCV RNA polymerase. Lead Optimization Refinement of sofosbuvir for increased efficacy and reduced toxicity. Preclinical Research Safety and Efficacy Testing Testing of sofosbuvir in vitro (lab cultures) and in vivo (animal models) for safety and effectiveness. Clinical Trials Phase I Testing sofosbuvir on a small group of humans for safety, dosage range, and side effects. Phase II Assessing the effectiveness of sofosbuvir in people with hepatitis C and evaluating safety. Phase III Large-scale trials to confirm efficacy and monitor for adverse reactions in a broader population. FDA Review & Approval New Drug Application Submission & Review Submission of the New Drug Application for sofosbuvir to the FDA and subsequent review and approval in December 2013. Post-Market Surveillance Ongoing Monitoring Continuous monitoring of Sovaldi for long-term safety and effectiveness, including additional studies. Patenting & Exclusivity Patent Rights and Market Exclusivity Gilead Sciences obtained patent rights and market exclusivity for Sovaldi. This table encapsulates the comprehensive process from initial discovery through to post-market surveillance, highlighting the specific steps taken in the development of Sovaldi.

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