clinical trial management

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 Teams

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...
 

5.1.2014 Clinical Development

Including Personalized Medicine in Clinical Trial Budgeting: Worth the Cost?

By Jennifer Harrell, Research Analyst Personalized medicine may change the way healthcare is provided, increasing the benefit of interventions to patients who need them most. Despite this excitement, it is important to consider that personalized...
 

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...