3 Ways China is Creating Opportunities in Pharma Clinical Trials Worldwide

China is experiencing a surge in activity in pharma clinical trials, becoming an increasingly central part of the pharmaceutical industry. Now the world’s second-largest national pharmaceutical market, China is also pharma’s fastest growing market, with even more significant expansion predicted by 2022. With greater outsourcing to APAC, and modern technology like EDC and eSource allowing … Read More →

mHealth and Pharma: Bridging the Regulatory Gap

The often daunting challenges of pharmaceutical development are no secret: throughout the industry, stakeholders experience hefty price tags, lengthy timelines, and difficulties with patient recruitment and retention. According to Pharmaceutical Research and Manufacturers, it takes an average of ten years and $2.6 billion to develop a new drug – and there is typically just a … Read More →

How Clinical Trial Regulations Can Foster Innovation

The clinical research industry is nothing if not regulated. To a significant degree, discussion about clinical research, whether in industry publications or CRO offices, centers around the regulatory side of things. And with the General Data Protection Regulation (GDPR) now in effect, there are even more regulatory standards to be discussed, managed, and navigated. But … Read More →

The Post-Brexit Clinical Trial Conundrum

The clinical trial industry in the UK is about to change. Why does it matter? Britain is on the verge of a big shift away from Europe. The idea of a unified Europe has been tarnished lately, catalyzed by an ongoing refugee crisis that has prompted strong nationalist sentiment and a decade-long underperforming economy that … Read More →

Tips and Tricks for FDA Submission

You’ve built your study and collected your data, and now it’s time for database lock. Congratulations! This is no easy task – any number of unforeseen setbacks can arise during a clinical trial, from patient attrition to misplaced source data and beyond – so don’t be afraid to enjoy the moment. Now comes the moment … Read More →

Changes to WHODrug Are Coming – Will You Be Ready?

In our industry, regulatory changes are rarely sudden. It can take years for authorities to discuss, draft, revise, and finally enact modifications to regulatory frameworks. And stakeholders are nearly always involved in the plan of implementation. However, as deadlines approach and several years of headway turns into months, any delay can threaten compliance. This will … Read More →

3 Insights into Medical Device Regulations from MAGI West

Back in November, MAGI’s Clinical Research Conference came to the Fairmont Hotel in San Francisco, California. Considering the wealth of insight on the agenda related to clinical trial technology, regulatory issues, and more, as well as the conference’s convenient location – Medrio’s headquarters is just about a mile down the street from the Fairmont – … Read More →

What Are the eClinical Implications of the New EU Data Regulation?

A recent article in Clinical Leader outlined concerns about Pharma’s ability to comply with the new EU Data Protection Regulation set to go into effect in May 2018. Indeed, companies doing business in the European Union will have major regulatory changes to contend with, including: Increased territorial scope, which includes where data is processed and … Read More →

Monthly News Roundup: August 2017

Welcome to the Medrio Monthly News Roundup, in which we brief you on a sample of events and developments taking place around the industry. This recurring update functions on popular demand – the stories in this post come from the articles in our social media feeds that garnered the most attention from our readers and … Read More →

3 Considerations as Clinical Trials Go Global

Ask an economist to name the most defining business trend of the 21st Century, and there’s a strong chance the answer will be globalization. Nations and regions are becoming increasingly intertwined through trade and outsourcing. Clinical research is no exception to this trend. Multi-country clinical trials have risen in recent years, and new regions have … Read More →