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Streamlining regulatory approvals in India

Relaxation and modification of the regulations to streamline regulatory approvals in India India has grown steadily as a preferred hub for conducting clinical trials. Thanks to the amendments made through the years to the Drugs and Cosmetics Act and Drugs and Cosmetics Rules. What is the Drugs and Cosmetics Act? The Drugs and Cosmetics Act […]

Modern technology in clinical research

As the world looks at various improvements and challenges everyday on a wide array of subjects, improvements in technology is what catches everybody’s attention in no time. Technology – in terms of developing new devices and machines, or improving the functionality of existing devices and machines, and writing new computer codes – has influenced the […]

Patient safety in clinical trials

Clinical trials are research studies done to analyze the safety and efficacy of a drug, treatment or device on humans. It requires participation of both patients and healthy individuals. Results obtained from clinical trials help to determine what treatment is best for patients with a specific medical condition, and if it is associated with any […]

National Regulatory Authority of India (NRAI) receives highest rating in WHO assessment

National Regulatory Authorities of India (NRAI) have successfully completed an assessment by the World Health Organization (WHO) with a maturity score of four out of five parameters. This score is the highest based on currently set definitions of assessment. NRAI has been declared “functional” based on scores obtained following assessment of nine functionalities. A WHO-led team […]

Clinical research has a bright future in India

Clinical trials guidelines and laws in India have recently been revised. The new updates make the approval process quicker, more predictable, and as per global norms. This has improved the future of global clinical trials in India. Last year has been particularly exciting for the Indian pharmaceutical market. With a compound annual growth rate of […]

Common challenge to patient participation in clinical trials

Enrolling and retaining patients in a clinical trial is a challenge. Here we discuss the challenge to patient recruitment and how a site management organization can help you with better patient participation for your clinical research. Common challenge to patient participation in clinical trials Ever wondered why enrolling and retaining patients in a clinical trial is a […]

5 Solutions to Avoid In Order to Ensure Recruitment Efforts Don’t Fail

Despite the heavy spending in patient recruitment, many sites often have trouble while finding the right patients for clinical trials. When the enrolment goals for a particular trial aren’t met, it can lead to delays in the trial and cost a lot of extra money as well. Avoiding the following 5 mistakes can ensure effective […]

All you Wanted to Know about The Phases of Clinical Trials

Clinical trials are conducted to evaluate the safety and efficacy of new drugs, biologics, or medical devices. Before the study is undertaken on human subjects, it is tested in laboratories and on animals. If the investigational product is found safe and efficacious in the preclinical testing, it is further approved for studies on human subjects […]

Four Trends From the Future of Drug Clinical Trials

Drug clinical trials are complex, prolonged and most importantly expensive – The Tufts Center for the Study of Drug Development states that it takes 2.5 billion USD to bring a drug successfully into the market. This multibillion dollar industry is witnessing some slow and steady changes. Read on to find out what is in store […]

How Research Firms Can Streamline Drug Studies

By definition a clinical trial is a study performed with patients in order to evaluate the effects, risks and benefits of a new drug or medication. Participants have to meet certain criteria in order to participate in such trials as the drug is typically designed to work against a particular disease or condition. There are […]