Clinical Trials - Articles

Clinical Trials |
Drug Clinical Trials and Approval in India

Drug Clinical Trials and Approval in India Short Description The approval process for new drugs clinical trials in India can be tricky. The roles of various regulatory authorities are crucial in ensuring high quality and well-researched products reach the consumers. Here’s a step-by-step guide. Introduction The drug approval process in India involves getting authorisation from

Clinical Trials |
Drug |
Unveiled Clinical Trials For Drugs: Exploring Research for New Treatments

Unveiled Clinical Trials For Drugs: Exploring Research for New Treatments Summary Clinical trials for drugs are essential to ensure their safety and efficacy. Drug trials usually progress through four phases: I, II, III, and IV. India is an emerging hub for clinical trials due to its diverse population and cost-effectiveness. Regulatory bodies like CDSCO ensure

Consumer Claims - Food |
India’s Food Sufficiency: Current Status & Impact of consumer claims for better new food trends acceptability

India’s Food Sufficiency: Current Status & Impact of consumer claims for better new food trends acceptability Summary India’s food sufficiency rate is influenced by agricultural production, distribution, and consumer awareness. It impacts the consumer acceptance to new food trends Efficacy evaluation of food in India is crucial to ensure nutritional adequacy and safety. Educating consumers

Clinical Trials |
Maximizing Efficiency in Clinical Trials: Leveraging the Expertise of CROs in India

Maximizing Efficiency in Clinical Trials: Leveraging the Expertise of CROs in India Summary As clinical trials are increasing in demand and complexity, more time, capital and efforts go into its management and successful completion. Indian contract research organizations (CRO) have seen a remarkable rise in demand due to low-cost structure, updated regulatory standards, and timely

Clinical Trials |
The Role of Clinical Research Services in India in Meeting Regulatory Expectations

The Role of Clinical Research Services in India in Meeting Regulatory Expectations Introduction In the field of clinical research, where novel findings and transformative medical breakthroughs emerge, regulatory compliance is a crucial cornerstone. In regulatory expectations meeting clinical research provides global Clinical trial approval, safety reporting, test license services, etc. Clinical research organizations in India

Clinical Trials |
Navigating the Regulatory Landscape: How CROs in India Ensure Compliance in Clinical Studies

Navigating the Regulatory Landscape: How CROs in India Ensure Compliance in Clinical Studies Introduction Clinical research organization’s in India have become leaders in guaranteeing adherence to complex regulatory frameworks. By means of their steadfast dedication to maintaining ethical standards and meticulous attention to detail, these organizations are essential in negotiating the intricate regulatory environment and

Clinical Trials |
Choosing the Right Clinical Research Organisation in India: Key Considerations and Benefits

Choosing the Right Clinical Research Organisation in India: Key Considerations and Benefits Introduction A Contract Research Organization (CRO) is a company contracted by manufacturers of pharmaceutical, biological or medical devices and in-vitro diagnostic kits to manage clinical research studies and other services to support product development in all phases of a clinical trial. What is

Clinical Trials |
Understanding the Importance of Real-World Evidence (RWE) in Clinical Trial Solutions

Understanding the Importance of Real-World Evidence (RWE) in Clinical Trial Solutions Introduction The process of obtaining data on a treatment’s actual effectiveness from medical records and other sources is known as real-world evidence or RWE. RWE can help researchers make more informed decisions about which therapies to make available by helping them comprehend practical results

Clinical Trials |
Unlocking the Potential of Real-World Evidence (RWE) in Clinical Trials: A Guide for Sponsors

Unlocking the Potential of Real-World Evidence (RWE) in Clinical Trials: A Guide for Sponsors Introduction RWE studies and randomised controlled trials (RCTs) should ideally work together to further explore and offer deeper insights into product effectiveness and safety in particular patient subgroups, such as those with comorbidities. Overview of Real-World Evidence in Clinical Studies Real

Clinical Trials |
Are Clinical Trials safe? What are the Safety Measures of Clinical Trials?

Are Clinical Trials safe? What are the Safety Measures of Clinical Trials? Introduction In a clinical trial, the safety and well-being of the volunteer participants is paramount. All researchers, investigators and healthcare workers involved in the clinical study must ensure that the risks of a trial do not outweigh its benefits. Participant inclusion and exclusion

Clinical Trials |
Clinical Trial Methods – Quantitative / Qualitative Clinical Research

What is Clinical Trial Method? Introduction Clinical trial methods integrate strategies to achieve valid conclusions about trial objectives and safeguard participants, utilizing both quantitative and qualitative research approaches. Emphasising the significance of statistical reasoning in clinical research, a clinical trial method is integral to the methodology of clinical trials. Therefore, understanding the various types of

Clinical Trials |
What Are the Technology Solutions for Clinical Trials?

What Are the Technology Solutions for Clinical Trials? Introduction Technological solutions continue to foster medical research, especially the clinical trial approach. Much like the impact it has had on our daily lives, digital technology has significantly revolutionised the medical research landscape. Introducing technologies into clinical trials has influenced them in numerous ways, such as bringing

Clinical Trials |
What is a Clinical Trial Treatment?

What is a Clinical Trial Treatment? Introduction A clinical trial or a clinical trial treatment involves researching to examine the effects of new tests and treatments on human health outcomes. Clinical trial treatments, as well as clinical trials in general, go through meticulous design, thorough review, and rigorous approval processes before initiation. When conducted with

Clinical Trials |
From RCT to BCT: How Big Data is Transforming the Clinical Trials Landscape

How big data is transforming the clinical trials landscape Currently, Randomized Controlled Trial (RCT) is the gold standard of clinical research, but with caveats. Translating biological efficacy into clinical efficacy is a major hurdle. Since RCTs are conducted in strictly monitored environments and even stricter guidelines, their implementation in real-world healthcare situations falls short of


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