How to Navigate Country-Specific Regulations in Global Clinical Trials
Are you aware of the worldwide differences in regulations for global clinical trials? Among other factors affecting global clinical trials, country-specific regulations differ in their rules and standards for: Gathering and protecting data Importing and exporting clinical supplies Handling validation issues Protecting human subjects Exercising quality control Gathering and Protecting Data: Global clinical trials are […]
Contract Research Organizations (CROs) – An Overview for Sponsors
Contract research organizations (CROs) are being increasingly used by biotechnology, pharmaceutical, and medical device sponsors due to various driving factors such as cost containment pressures, globalization of clinical research, and the ability of CROs to conform to government regulations and international standards. As per the latest statistics, the CRO industry is expanding with about $50 […]
Quick Guide for Conducting Global Clinical Trials on Time and within Budget
The interdependence of time and budget in clinical research trials has far-reaching consequences on the research protocol. Missed or delayed appointments due to lack of patient transportation or reimbursement can not only affect the study schedule but also raise questions about the reliability of the data. It is critical to have a timely negotiation and […]
Why These Are the Top Countries for Conducting Clinical Trials
Clinical trials are currently being held on every continent except Antarctica. However, emerging countries have long been rising to the top level of consideration for conducting clinical trials. Most sources identify emerging countries based on their economic development and reform programs: They “have begun to open up their markets and ’emerge’ onto the global scene. […]
Three Ways to Reduce Cost and Complexity in Clinical Trials
When discussing ways to reduce cost and complexity in clinical trials, the over-riding mantra is to keep expectations realistic. Any clinical trial that begins with an unrealistic budget or schedule is bound to become mired in unexpected costs and the complexities associated with getting back on budget, raising more money and revising the schedule. Those […]