Global expansion is no longer a strategic option for pharmaceutical and medical device companies. It is a commercial necessity. Yet, from a chief risk officer’s vantage point, global expansion is also where regulatory risk multiplies at the fastest possible rate.   Across FDA-regulated markets, EU MDR territories, emerging Asia-Pacific zones, and Middle Eastern regulatory ecosystems, the […]

India’s medical device industry is on the rise. Initiatives like Make in India, paired with a rise in chronic diseases and VC funding, have helped the Indian medical device market become the 4th largest market in Asia and top 20 globally.    Along with the rise in the medical device industry, regulatory expectations under UDSCO are […]

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 […]