Most people believe a clinical trial fails because of something that happens during the study. A protocol deviation. A regulatory delay. A recruitment slowdown. But the truth is far simpler. Most trials fail long before the first participant ever steps into a site. One of the most critical choices a sponsor has to make is […]
The FDA approved 50 new drugs in 2024, compared to roughly 35 in 2023, signaling steady growth in drug approvals. This has led to an increase in demand for medical writing services. High-quality medical writing is one of the most critical foundations of clinical research. Every protocol, clinical study report, regulatory submission and safety document must […]
Early-phase clinical trials, particularly Phase I and early Phase II, are often seen as exploratory stepping stones. Yet, what happens at these stages can determine the fate of an entire drug development program. At the heart of these early decisions lies biostatistics: the scientific foundation that transforms raw observations into meaningful insight. Unfortunately, many sponsors underestimate its importance. Poor biostatistical […]
Sponsors face mounting pressure to deliver high-quality trials on time and within budget. That’s why having a reliable partner for clinical monitoring is critical. Whether you’re considering traditional clinical trial monitoring or exploring hybrid models, the right monitoring partner can turn oversight from a cost centre into a value driver. At Innovate Research, we’ve seen how an intelligent, data-driven approach to monitoring can transform oversight into measurable operational and […]
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 […]
