rescue study

When it’s time to rescue a study

Planning and executing a global, interventional medical device study is a complex process. Whether you’re managing the study internally or partnering with a qualified CRO, there are times when studies may not go as planned. If multiple problems arise that … Read More

Medical Device Development

Medical Device Development: Distinctions Matter in Clinical Studies

Developing medical device clinical trials for investigational Class II or Class III devices typically means planning around a lot of moving parts that aren’t normally factors in drug studies. Devices are often engineered to have multiple components—hardware, software and/or medicinal … Read More

mHealth

mHealth: Trendy or Revolutionary?

The use of mobile and wearable health (mHealth) technologies has garnered significant attention recently.  From the launch of Apple’s ResearchKit in March to Medtronic’s recent approval for the first remote monitoring app for implantable pacemakers, mHealth is making a strong … Read More