clinical operations strategy

7.17.2014 Clinical Development

Clinical Trial Staffing: Recruiting CRAs Best Suited to Trial Needs

By Natalie DeMasi,Research Analyst Clinical research associates (CRAs) are a crucial part of a company’s clinical trial staffing. CRAs often work as a liaison between the company and investigator sites, ensuring that the trials run smoothly. As such,...
 

7.16.2014 Clinical Development

All Right, Meow: Patient Recruitment for Animal Health Studies is Serious Business

By Sarah Ray, Research Analyst Patient recruitment isn’t just human subjects. Cutting Edge Information has conducted a number of clinically focused projects, examining an array of industry challenges.  How companies recruit for their clinical...
 

7.7.2014 Clinical Development

Aligning the Goals of a Diverse Risk-Based Management Team

As clinical research monitoring strategy moves toward a risk-based approach, creating a dedicated team to define a risk-based monitoring (RBM) strategy and oversee the management of RBM on a per trial basis is beneficial. Dedicated risk-based management teams are...
 

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...