post-marketing study

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...