Clinical research has entered a new era; one where data from everyday patient experiences holds as much value as data from carefully controlled clinical trials. These insights, known as Real-World Evidence (RWE), are helping researchers, regulators, and healthcare providers make smarter, faster, and more patient-centred decisions. In India and across the world, Real-World Evidence Studies […]
Clinical research is constantly evolving due to the introduction of advanced technology and artificial intelligence. The success of a clinical trial is no more about strong data collection. Factors like patient safety, protocol adherence, and regulatory compliance should also be considered. This evolution has caused a dilemma among pharmaceutical companies: ‘How do you identify clinical […]
Imagine investing millions in a clinical trial only to face rejection from regulators because of data inconsistencies that are completely avoidable. Even worse, consider the risks to patient safety if adverse events are overlooked due to weak statistical planning. Unfortunately, this scenario is not rare. Studies show that nearly 90% of clinical trials fail to […]
In the race to bring new therapies and technologies to market, clinical operations have become non-negotiable to life sciences. Whether you’re developing a pharmaceutical compound, a nutraceutical formulation, a biotech innovation, or a medical device, the ability to execute trials swiftly and safely is what separates successful launches from stalled pipelines. At Innovate Research, we […]
Running a clinical trial in India comes with great opportunities: a large patient pool, cost advantages, and growing infrastructure. But one major challenge that can delay or derail a trial is poor data management. According to the Indian Council of Medical Research (ICMR), a significant number of clinical trial delays are linked to poor quality […]
After spending a few years researching, developing, and collecting data for breakthrough therapies and novel devices, it’s important for the pharma company to get through the regulatory submissions. However, navigating the Indian regulatory system, especially under the Central Drugs Standard Control Organisation, often proves challenging due to evolving guidelines, multi-tiered requirements, and limited standardisation. Innovative […]
When it comes to advancements in medicine, clinical trials are often at its centre. However, to run them smoothly, safely, and accurately, they need constant oversight, highlighting the need of clinical monitoring. In recent years, clinical trial monitoring in India has evolved rapidly, shifting from traditional on-site checklists to modern, tech-driven approaches. Today, India is […]
Clinical trials are the foundation of modern medicine, but without data integrity, their findings can be unreliable or even unsafe, leading to wrong conclusions about the treatment’s effectiveness. This is where clinical trial monitoring plays a critical role. From detecting data discrepancies to ensuring protocol adherence, clinical monitoring acts as the backbone of reliable, ethical […]
Oncology is one of the most complex and resource-heavy areas of clinical research. Unlike other therapeutic domains, cancer trials must navigate rapidly evolving treatment methods, complex trial designs, and significant safety concerns. Often while racing against time for patients with life-limiting conditions. Here, generalized trial management approaches often fall short. Specialized clinical trial monitoring services […]
Submission of inadequate documentation can lead to delays and postponements by months or longer. Today, the success of a new drug depends not just on the quality but also on the precision and clarity of the documentation. Strict regulatory authorities such as the US FDA, EMA, and CDSCO evaluate hundreds of new products every year, […]
