Harsher Regulatory Scrutiny Has Lead Teams to Manage the IIT Process from Proposal Submission to Final Follow-Up
80% Of Surveyed Companies Have Dedicated Investigator Initiated Trial Management Groups in Place, Finds Cutting Edge Information
Cutting Edge InformationElio Evangelista, 919-403-6583
With regulatory agencies preparing to track every penny exchanged between pharmaceutical companies and physicians, executives cannot afford to avoid implementing proper oversight of any activities involving such payments. It is not surprising, then, that 80% of companies surveyed for Cutting Edge Information's medical affairs study now have dedicated IIT management groups in place to manage the IIT process from proposal submission to final follow-up on studies completed by investigators.
Additionally, the report found that dedicated IIT groups also serve as the first line for proposal review, weeding out undesirable submissions, trimming formal review committees' responsibilities and shortening timelines for the approval process. "During formal review, dedicated IIT management teams moderate the process, setting standards for approval and playing a role in the actual review committee meetings," said Adam Bianchi, chief operating officer at Cutting Edge Information.
"Whether centralized or not, dedicated IIT management teams pay dividends for companies wanting to make the most of their IIT programs," added Bianchi. "These teams streamline the IIT process, first by setting specific focus for investigator initiated trials and trying to match those up to KOL proposals, all without crossing any ethical lines."
Once companies approve the study proposals, IIT managers follow up to make sure the coordinating with external investigators gather the proper feedback to make sure the trials are progressing as promised and the investigator meets the agreed upon milestones. When investigators complete studies, IIT managers make sure the company uses the findings to their fullest extent by coordinating with and marketing groups.
Perhaps most importantly, IIT management teams ensure that all IIT activities are standardized and properly documented throughout the entire process. In so doing, any regulatory agency wanting to see details of interactions between companies and their external physician contacts will be able to do so.
"Investigator Initiated Trial Management" () contains benchmarks and best practices that will enable better IIT management, from allocating resources efficiently to streamlining processes.
For more information about investigator trial management, contact Elio Evangelista at 919-403-6583.