clinical trial management

4.26.2012 Medical Affairs

More Companies Integrating Planning and Execution of Phase 4 Clinical Trials Under Medical Affairs

By David Richardson, Research Team Leader Post-marketing research is a growth area. An ever more cautious and stringent regulatory environment, payers that require more and more data to justify formulary approval and reimbursement, and more crowded...
 

4.23.2012 Regulatory

The Widening Talent Gap in Regulatory Affairs is a Problem for Small Pharma

By Casey Ferrell, Senior Research Analyst In sports, payroll tends to have a big impact on the quality of a roster. Though it doesn't always equate to Stanley Cups or World Series rings, the rule is pretty simple: more money equals better players equals...
 

3.5.2012 Clinical Development

Adaptive Clinical Trials: Three Challenges that Give the Pharma Industry Pause

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...
 

2.17.2012 Clinical Development

Understanding Culture is Crucial for Successful Emerging Markets Clinical Trials

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,...
 

1.4.2012 Medical Affairs

Investigator Initiated Trial Budgets Set to Rise in 2012

Our current review of pharmaceutical and biotechnology strategy for the new year finds that 42 percent of companies will be increasing their budgets for investigator initiated trials. Companies fund investigator initiate trials (IITs) to support additional clinical...
 

12.5.2011 Clinical Development

Outsourcing of Phase II Drug Development Now Accounts for 63% of R&D Budgets

Clinical development outsourcing budgets have steadily risen since 2008, but Phase II outsourcing has grown at a faster rate than any other phase, according to our recent clinical development study. Patient recruitment, complex setup requirements, and the need...
 

11.2.2011 Medical Affairs

Phase 4 Trials Conducted within Clinical Development often Face Stiff Internal Competition

By David Richardson,Research Team Leader Within pharmaceutical companies that manage Phase 4 trials through their Clinical Development organizational structure, Phase 4 clinical programs must compete directly with the company's own pre-launch clinical...
 

11.1.2011 Clinical Development

Mobile Focus on Commercialization Creates Clinical Development Opportunities

By Casey Ferrell,Research Analyst Smartphones are quickly becoming the standard device consumers use to connect to friends, the internet and the world at large. The share of smartphones as a proportion of overall device sales has increased to 29 percent...
 

10.7.2011 Medical Affairs

Phase IV Clinical Trials Outsourcing Up

Regulatory pressure, more demanding payers and stiffer competition push overall Phase IV growth Our recent Phase IV clinical research report finds that Phase IV work is growing rapidly, meaning expanding budgets for post-marketing research studies. And more...
 

9.12.2011 Clinical Development

Internal CROs Bring Outsourcing In-House

The percentage of clinical budgets that sponsors allocate to outsourcing often swings like a pendulum: increasing for a few years and then decreasing, only to increase again a few years later. Currently, the pendulum is swinging toward increased levels of outsourcing. However,...