post-marketing study

7.23.2013 Lifecycle Management

From Phase 3 to Post-Marketing Studies: The Journey of Aripiprazole IM (Abilify Maintena)

By Sarah Ray, Research Analyst Schizophrenia is a complex psychological disease state that distorts patients’ cognitive and emotional responses. Patients may experience positive symptoms such as delusions, hallucinations or disorganized thought...
 

8.21.2012 IIT Studies

Looking for Better IIT Submissions? Try moving the process online.

As the old saying goes, "Good help is hard to find." Well, sometimes the best option is to make it easier for the help to find you. Our research has shown that Investigator-Initiated Trial proposals are on the rise over the last three years — averaging 173.3...
 

7.26.2012 Medical Affairs

Accelerating Phase 4 Clinical Trials a Matter of Improving Enrollment

Phase 4 clinical trials not only serve to gather valuable data surrounding drugs’ safety, tolerability and real-time effectiveness, but also to test potential new indications, develop stronger marketing profiles, gain payers’ favor and prove superiority over...
 

5.9.2012 IIT Studies

Four Guideposts to Improve Investigator-Initiated Trials Payment Processes for FMV Compliance

By David Richardson, Research Team Leader The Office of the Inspector General at Health and Human Services (OIG) has been highly focused recently on tracking and publicizing pharmaceutical companies' payments to thought leader physicians and clinical...
 

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...
 

3.16.2012 IIT Studies

Investigator Initiated Trial Management Earns the Dedicated Resources It Deserves

By Ryan McGuire, Senior Research Analyst Pharmaceutical companies are growing more strategic in their investigator initiated trial (IIT) selection. As Research and Development organizations have sharpened their focus on mission-critical pre-approval...
 

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...
 

12.6.2011 IIT Studies

Internet-Based Investigator Initiated Trial Submission Systems Grow

Over Half of Drug Companies Now Use Electronic or Web-Based Tools for Managing Proposals Electronic or web-based submission systems for investigator initiated trial (IIT) proposals are now in place at 58% of biopharmaceutical companies, and that number is expected...
 

11.29.2011 Medical Affairs

Phase IV Trials Becoming Regionalized by Differences in Regulatory Environments and Payer Demands

Our recent study of Phase IV Trials found that post-marketing studies are increasingly "regionalized" to better meet U.S. and European market requirements. Differences in what regulators and payers are looking for in post-approval information in Europe and...
 

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...