decentralized & virtual clinical trials

Over the past years, the number of conferences and publications devoted to decentralized and digital clinical trials has skyrocketed in the pharmaceutical research sector. Nearly every clinical research company has joined the conversation, fuelled by the global pandemic. Conferences are there almost weekly to discuss methods and equipment for transferring laboratory-based research to clinical settings. […]

Read More →
medical device regulatory in Malaysia

There is a growing demand for medical devices in Malaysia, and overseas manufacturers are showing interest in registering and marketing their medical devices in Malaysia. The Medical Device Authority (MDA), the regulatory body for the medical device industry in Malaysia, projects that the market will grow at a 16.1% annual rate to reach US$1.4 billion. […]

Read More →
Malaysia drug approval regulatory

According to a recent analysis by an agency, the Malaysian pharmaceutical market is anticipated to increase from $2.3 billion in 2015 to $4.6 billion by 2022, reflecting a 9.5% CAGR. Seeing this demand many manufacturers are showing interest in registering their drug products in Malaysia. This information was last updated in March, 2023. The demand […]

Read More →
patient recruitment strategy in clinical trials

A clinical trial’s outcome depends on several variables, but one of the most important is patient recruitment. Ineffective trial recruitment strategies can cause late-stage trials to be delayed by roughly 11 months, increasing operational costs and extending time to market. Clinical trial recruiting strategies begin with the patient in mind and include a range of […]

Read More →
Clinical research associates for clinical trials in Thailand

Clinical research is a field that can be difficult in and of itself. So it is essential to understand the knowledge and skill requirements for the various roles. A healthcare professional who oversees various duties for clinical trials and other kinds of medical research is a clinical research associate (CRA). Ensure to protect of the […]

Read More →
Nutraceuticals & food supplements regulatory in Japan

Japan has the same regulations and practices for nutraceuticals, food, and beverage goods as any other nation. Legitimate safety regulations, regulatory protectionism, and customs taxes present manufacturers with significant obstacles when they attempt to enter the market. The Ministry of Health, Labour, and Welfare (MHLW) and Consumer Affairs Agency (CAA) are in charge of enforcing the Food […]

Read More →
choosing a BIOSTATISTICIAN for clinical trial

Clinical Biostatistician and biostatistics are crucial for clinical trials and team members because they are path deciders for finding clinical trial end-points. For instance, it is essential to understand how to derive the components used in the analysis and assumption of the resulting data.  The statistician’s role is critical from the start to ensure that […]

Read More →
Food supplements market and clinical trials

Although people seek dietary supplements, many are concerned about the potential benefits, safety, and results. Therefore, clinically tested and approved food supplements have a good market. We should conduct clinical trials on food supplements under Good Clinical Practice (GCP) to determine the potential benefits of dietary supplements. Health and diet have received more attention since […]

Read More →
Clinical Trial Software & Compliance

Although many clinical trial sites wish to use technology, they are concerned about software compliance, particularly regarding 21 CFR Part 11 compliance. Using non-compliant technology can result in audits and tense interactions with the FDA and other regulatory authorities.  In order to obtain smoother and quicker approvals from the regulatory authorities, researches need to use […]

Read More →