SEPTEMBER 2021 Research Alert

This month we added five new studies to the Best Practice Database, the research repository for Best Practices, LLC. This month's new studies explore two topical areas: Medical Affairs' evolving role in product launch and management of Investigator Initiated Trials for CNS products. The first three studies revolve around IIT management in CNS, with the first document examining structure, activities, and oversight; the second study addressing resource allocation and networking, and the third document study investigating approvals and communication. The Medical Affairs studies look at how the function's launch role is changing, with the fourth study examining medical's role, collaboration, and digital use and the fifth study addressing timelines, success factors and digital influence.

The new Best Practices, LLC studies listed below under Newly Added Research explore how leading companies have made their operations more effective across these different areas.

	Download: Best Practices in the Management of Investigator Initiated Trials in CNS Therapeutic Area: Structure, Activities and Oversight (5693) The rising number of IIT submissions for CNS drug candidates has made IIT management a critical operational area for CNS manufacturers. This research will help in optimizing key operational aspects of IIT management at CNS companies, capturing critical metrics and insights on team structure, leadership, and functional involvement.
	Download: Best Practices in the Management of Investigator Initiated Trials in CNS Therapeutic Area: Resource Allocation and Investigator Networking (5694) As most CNS manufacturers rely on IITs to increase the breadth of clinical programs, it is important that organizations appropriately manage their funding and budget. Best Practices, LLC conducted this research to provide a detailed roadmap for improving IIT management in staffing, budget, investigator networking and payment milestones.
	Download: Best Practices in the Management of Investigator Initiated Trials in CNS Therapeutic Area: Approvals, Communication and Future Prospects (5695) With increasing number of IIT submissions for CNS drug candidates, it is important that CNS manufacturers properly vet each proposal and approve the ones that demonstrate scientific merit and align with corporate objectives. This benchmarking research examines critical metrics and insights on IIT submission review systems, communication, performance metrics and future prospects.
	Download: The Evolving Role of Medical Affairs in Product Launch: Role, Collaboration and Digital Use (5696) Change has been constant with Medical becoming the hub for insight and intelligence for the company. Additionally, the COVID-19 pandemic has triggered a rapid digital technological adoption for Medical Affairs. This research probes digital tool utilization and launch tool deployment, roles and responsibilities, and cross-functional alignment.
	Download: The Evolving Role of Medical Affairs in Product Launch: Timelines, Success Factors and Digital Influence (5697) The last decade has seen Medical Affairs move from a support function to a strategic, central function in biopharma. Change has been constant with Medical, from taking the lead in shaping the evidence agenda, establishing excellence in external engagement to value communication. This research identifies medical activity timelines, performance metrics and explores critical success factors and digital implementation for launch preparedness.