clinical trial management

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...
 

4.2.2014 Medical Affairs

Making the Most of Scientific Advisory Boards with Clear Objectives

By Jacob Presson, Research Analyst When bringing together a group of active clinicians and specialists for a scientific advisory board, companies should make sure to maximize the effectiveness of the resources seated around the table.  Each person...
 

3.31.2014 Clinical Development

Clinical Trial Management: Risk-Based Monitoring Represents Viable Oversight Solution

By Sarah Ray, Research Analyst With the growth in companies’ pipelines, clinical trial management becomes essential. One aspect of study oversight, monitoring trial risk, has evolved in recent years.  In traditional clinical studies, clinical...
 

2.21.2014 Clinical Development

Roche’s Bad News Emphasizes Clinical Data Transparency and Patient-Reported Outcomes

By Nicole May, Research Analyst Roche’s recent announcement about the failure of its schizophrenia drug, Bitopertin, highlights two hot topics within pharma: clinical trial transparency and patient-reported outcomes (PROs). The drug failed to...
 

2.4.2014 Clinical Development

Planning Ahead to Meet Clinical Data Stakeholders’ Expectations

By Sarah Ray, Research Analyst Clinical data transparency has become one of the hottest issues for pharmaceutical and biotechnology clinical development and regulatory teams. From new disclosure policies at PhRMA and the EFPIA to working with the...
 

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...
 

12.31.2013 Strategic Planning

New Year’s Resolutions for Pharma Teams

By Victoria Cavicchi, Research Analyst As 2013 comes to a close, the Pharmaceutical and Life Science industries are gearing up for new challenges and new opportunities in 2014. Cutting Edge Information is pleased to present a snapshot of our 2014...
 

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...