clinical operations strategy

For companies that don’t have an in-house diagnostics development program, especially those not focusing on therapeutic areas optimized for companion diagnostic (CDx) development, outsourcing to a diagnostic firm is a great solution.  There are many reasons...

Staying on schedule with planned timelines is both essential to maximizing a product’s potential and monstrously difficult to achieve.  New data that we’ve compiled in a recent study (see Figure 1) show an average of more than five months’ difference between...

Pharmacyclics Inc. recently announced that the FDA granted an additional Breakthrough Therapy designation for its investigational oral agent ibrutinib as a monotherapy to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with deletion...

Finding patients in a very specific disease state is difficult enough, but in the shadow of Phase III, it’s nearly impossible.  In fact, next to Phase IV, Phase III patient enrollment looks easy.  Phase IV patient recruiters are stuck competing not only with...

The drug industry’s reliance on companion diagnostics (CDx), particularly among large companies, has grown in recent years. According to the BasePair Group, CDx Partnerships with pharma have more than doubled between 2011 and 2012. Cutting Edge Information found...

Imagine receiving an invitation to a banquet at which everything is free and attendees win prizes—but only if they arrive on time. Wouldn’t it make sense for potential attendees to use technologies (such as mobile calendars or GPS devices) to help them determine...

By Shaylyn Pike, Senior Research Analyst Pharmaceutical companies' global clinical development strategies are diverse, but there are some points of agreement: clinical trials in emerging markets are more successful when companies hire local expertise....

By Elio Evangelista, Director of Research The promise of adaptive clinical trials leading to significant cost savings is attractive, and many drug companies have already put the strategy into practice. But most times, companies implement adaptive clinical...

By Shaylyn Pike,Senior Research Analyst The emerging markets are not the United States, nor are they the European Union. It seems like a simple statement, but in Cutting Edge Information's latest research on clinical development in the emerging markets,...

While sponsors maintain editorial distance from investigators' findings, they increasingly push researchers to take action on publication Published data from investigator-initiated trials (IIT) have proven extremely valuable for both scientific and commercial...