2024-04-19 06:15
According to the National Cancer Institute (NCI), a solid tumour is a mass of tissue that usually does not contain cysts or liquid areas such as sarcomas (arising from connective […]… Read More
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ProRelix Research is the best clinical research organization (CRO) with global service capability supporting Phase 1, 2, 3 and 4 clinical trials for Pharma, Biotech, Biopharma, Medical device, Nutraceutical and Herbal companies. Our excellent team of researchers have been working on clinical development plans of our clients with outstanding clinical research services in US, India, Australia and Europe. To know more please visit our website at www.prorelixresearch.com
2024-03-12 05:00
Explore the dynamic synergy between industry and academia in groundbreaking medical research through Investigator Initiated Trials (IITs) and Proof of Concept Studies. Uncover the collaborat… Read More
2024-03-01 12:35
Biologicals products occupy a significant place in the treatment landscape of several autoimmune diseases and cancers and are most often the only choice of treatment and management of severa… Read More
2024-02-26 05:21
The role of Real-World Evidence (RWE) in drug development helps in gaining a deep insight into how real-world data and experiences come together to shape impactful pharmaceutical solutions… Read More
2024-02-20 08:37
Crafting impactful oncology clinical trial protocols requires a strategic approach to ensure rigorous research, patient safety, and meaningful outcomes. Explore key considerations and best p… Read More
2024-01-23 12:11
Despite advancements in digitization and remote or decentralized trials, traditional clinical trials with a central site, in-person recruitment and monitoring, and paper-based or electronic… Read More
2023-12-28 11:49
Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered… Read More
2023-12-14 09:02
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The European Med… Read More
2023-11-27 08:48
The United States Food and Drug Administration (FDA) has strict regulations regarding pharmacovigilance activities that are a part of post-marketing studies for drugs and medical devices tha… Read More
2023-11-15 07:08
The growing impetus for the conduct of clinical trials outside the United States for products and medical devices intended to be used in the US include multiple reasons such as […]
Th… Read More
2023-11-02 07:25
Although clinical trials provide useful information regarding the efficacy and safety of new drugs, biological products, and medical devices, the information captured through them is not all… Read More
2023-10-27 06:05
Discover how eCOA in clinical trials transforms data collection and uncover the game-changing benefits of electronic data capture in clinical research. Introduction: What is eCOA Clinical Tr… Read More
2023-10-20 06:34
Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects and other drug-related problems. It is an i… Read More
2023-10-20 04:53
Data analytics, technology, and accessibility to the internet and healthcare has led to a paradigm shift in the way clinical trials have been conducted. Traditional clinical trials that have… Read More
2023-10-18 09:42
The increasing focus and acceptance of real-world data (RWD) in clinical decision making has led regulatory authorities and sponsors to understand its influence on data management that is an… Read More
2023-10-13 05:56
Clinical trials are critical for the approval of new drugs and medical devices necessitating that data that is derived from them to make regulatory decisions is done so in a […]
The p… Read More
2023-09-26 12:02
Endocrine disorders result from the improper functioning of endocrine glands that secrete and regulate hormones responsible for functioning of various organs. Imbalances in hormones or inabi… Read More
2023-09-18 06:09
The rising prevalence of ophthalmology disorders such as dry eye disease (DED) and vision-related issues is largely related to the increasing use of mobile phones, tablet screens, and laptop… Read More
2023-09-08 05:45
Autoimmune disorders comprise several diseases in which the immune system mistakenly attacks and destroys the body’s own healthy cells instead of destroying bacteria and viruses to kee… Read More
2023-08-14 06:59
Software as a Medical Device (SaMD) refers to a class of medical software intended to be used for medical purposes or that is designed to carry out medical functions without […]
The p… Read More
2023-08-03 11:45
Although the United States Food and Drug Administration (FDA) has always supported and advocated the idea of decentralized trials, the real adoption and application of decentralized aspects… Read More
2023-07-27 06:33
Ensuring the safety and efficacy of new drugs, medical devices, and biological products does not end once the treatment is approved or is on the market but extends to the […]
The post… Read More
2023-07-06 11:08
Biosimilar clinical trials and study designs’ Considerations The rising prevalence and large market share of biological products emphasize their importance as treatment options for sev… Read More
2023-06-26 09:45
As per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related ar… Read More
2023-06-06 12:26
Being the second most populous country in the world with skilled labor and good infrastructure, India is a favorable destination for clinical trials for a wide variety of diseases. However… Read More
2023-05-31 07:38
Introduction: Clinical trials are a crucial component of the pharmaceutical and medical research industry, aimed at evaluating the safety and effectiveness of new drugs, treatmen… Read More
2023-05-15 11:31
Clinical Research Organizations (CROs) are companies that provide support to the pharmaceutical and biotech industries by managing various aspects of the drug development process and conduct… Read More
2023-04-27 10:51
Pharmacovigilance is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse event… Read More
2023-04-05 11:16
Clinical trials form the decisions for regulatory approval of drugs and medical devices and as a result are the most important step of a drug development program. In addition to […]
T… Read More
2023-02-13 06:21
Historical events such as the sulfanilamide elixir tragedy that resulted in the mass poisoning and the deaths of hundreds of patients in the 1930s and the thalidomide scandal which caused [… Read More
2023-01-12 09:54
In India, the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Government of India is the National Regulatory Authority (NRA) responsible… Read More
2022-12-27 08:39
Clinical trials form the crux of all regulatory decisions regarding any new health intervention such as drugs and medical devices and thus require to be performed with the utmost care [&hell&hell…Read More
2022-12-12 11:45
The post-pandemic clinical trial landscape has paved way for the integration of technology, data analytics, and digitization to facilitate all aspects of trial management from patient identi… Read More
2022-11-23 09:11
Biological products have unlocked the potential for the management of several diseases such as cancers and autoimmune diseases for which treatment with small molecule, chemically synthesized… Read More
2022-10-31 10:26
A clinical trial is a culmination of the several stages of a drug or medical device development program that begins with the discovery of a candidate molecule followed by preclinical [&helli&hell…Read More
2022-09-21 09:40
According to the World Health Organization (WHO), cancer is the leading cause of death worldwide, with a death rate of one in six in 2020 (1). Aside from the high […]
The post Cancer… Read More
2022-08-23 11:41
Real-World Evidence Studies: Introduction, Purpose, and Data Collection Strategy The first image that comes to mind when one thinks of where safety and efficacy data for a new treatment is [… Read More
2022-07-25 08:51
Planning a Rare Diseases Clinical Trial? View from United States and Europe The Orphan Drug Act (ODA) defines a rare disease as a disease or condition that affects less than […]
The p… Read More
2022-06-29 11:19
According to the World Health Organization (WHO), cancer is the leading cause of death worldwide, accounting for nearly 10 million deaths in 2020 (1). In addition, GLOBACAN estimated… Read More
2022-05-26 11:51
The United States has always been and remains to be the leading place for the conduct of clinical trials. According to Clinicaltrials.gov, the largest clinical trials registry, 32% of regist… Read More
2022-03-15 09:40
Clinical trials are research studies in which participants volunteer to test new treatments, therapies, or tests in the hopes of preventing, detecting, treating, or managing a wide range of… Read More
2022-02-28 06:47
The World Health Organization (WHO) defines clinical trials as a type of research that studies new tests and treatments and evaluates their effects on human health outcomes (1). Clinical tri… Read More
2022-02-08 05:58
A lot has changed over the past few decades in the way clinical trials are conducted. Advances in data management systems, risk-based monitoring, pharmacovigilance, electronic databases, and… Read More
2021-12-16 05:58
Drug development strategy for US FDA It takes a staggering 12 years on an average for a drug to travel from the laboratory bench to your bedside! This is coupled […]
The pos… Read More
2021-11-17 10:16
Covid 19 Booster Dose – Should we consider it? The idea of booster doses for Covid-19 vaccinations is gaining traction around the world, but India remains a skeptic. Various countries… Read More
2021-11-09 08:24
Use of Social Media and Mobile Devices – Study Participants Recruitment There has been a significant change in the clinical trial and advertising industries over the last five years th… Read More
2021-08-13 06:52
Acceptance of foreign clinical trials data by US FDA Foreign Clinical Trials (FCTs) Prior to the 1962 Kefauver-Harrison Amendments, it was uncommon for a Sponsor to submit FCTs data. In [&he&hell…Read More
2021-07-21 11:38
Emergency Use Authorisation Approval Process of US FDA and Treatments Approved for COVID – 19 in the USA The COVID-19 pandemic has transformed the worldwide regulator performing on app… Read More
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