clinical operations strategy

4.3.2014 Clinical Development

Selecting the Right Vendor for Phase I Clinical Trials: Preferred Provider List or Bidding Process?

By Natalie DeMasi, Research Analyst Phase I clinical trials are supposed to be the quickest, easiest trials with the simplest question in mind: will the drug harm the patient?  No? Good, then you may proceed. However, sometimes the trials are not...
 

1.2.2014 Clinical Development

Get Safety Data Right the First Time in Critical Phase 3 Trials

By Ryan McGuire, Research Team Leader Getting safety data correct the first time is essential to keeping drug development on schedule and avoiding potentially costly overruns.  Several recent cases in which regulators requested additional drug...
 

12.23.2013 Clinical Development

Targeting the Alpha 7 Nicotinic Receptor May Be More Difficult Than Companies Originally Anticipated

By Sarah Ray, Research Analyst One of the characteristic symptoms of schizophrenia is patients’ inability to differentiate among important and unimportant stimuli in their environments.  Researchers attribute this symptom to a “P50 Auditory...
 

12.2.2013 Clinical Development

Clinical Teams Should Re-Think Risk-Based Monitoring to Improve Their Bottom Line

By Jennifer Harrell, Research Analyst Often, news surrounding the clinical development process seems pretty grim.  R&D budgets are being slashed, promising new compounds fall short in late-stage trials, patients struggle to find and enroll...
 

11.26.2013 Clinical Development

Let’s Give Thanks for Specialized Clinical Trial Third-Party Vendors

By Nicole May, Research Analyst This Thanksgiving, let's all put down our forks and thank third-party vendors performing critical clinical trial tasks. Third-party clinical trial vendors provide Continue reading “Let’s Give Thanks for...
 

5.28.2013 Clinical Development

Nexavar Debuts Thyroid Cancer Indication at ASCO

By Nicole May, Research Analyst The ASCO abstracts are out!  Well most of them — some of the most exciting will be kept under wraps until the conference begins early next month.  One of those generating the most buzz is Abstract #4, “Sorafenib...
 

5.14.2013 Clinical Development

CDx Partnerships: What You Want and What You Don’t Want

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...
 

4.18.2013 Clinical Development

Minimize Phase I Clinical Trials Delays with Early CRO Communication

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...
 

4.17.2013 Clinical Development

Promising Oncology Drug Receives Third Breakthrough Designation from FDA

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...
 

1.23.2013 Clinical Development

Phase IV Patients Are a Virtue

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...