Our complimentary white papers draw on our primary research findings to provide you information on critical life sciences topics. Please fill out the short form accompanying each white paper in the list below. You will then be directed to links to the downloadable PDFs.
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Latest White Papers
Exciting Trends in Medical Affairs 2016
Medical affairs is evolving into a strategic function invaluable to healthcare decision makers and the internal organizations of life science companies. While there are many parts to this evolution, this paper highlights three points. First, the MSL role is expanding beyond relationship-building. Today, MSLs are getting involved in clinical trials, aid in payer discussions and bring insights back to the internal organization. Second, healthcare decision makers increasingly emphasize real-world evidence, and Phase 4 teams are innovating trial designs that go beyond standard randomized controlled trials to get a closer look at product effectiveness, utilization and costs in a clinical setting with a diverse patient population. Finally, the demand to prove value encourages medical affairs to bring strategic insights to the internal organization. These insights can inform company strategies and demonstrate how medical affairs’ value relates to both external and internal stakeholders.
Ensuring Compliant TMF Practices: Common Regulatory Inspection Pitfalls and How to Avoid Them 2016
This white paper provides a series of recommendations to help pharmaceutical and medical device teams fine-tune their TMF management operations. Internal teams must ensure that sponsor-managed files are comprehensive and reflect the standards of Good Clinical Practice (GCP). Findings from European and British regulatory agencies’ inspections highlight the aspects of TMF management that companies are likely to find most challenging.
The State of Global FMV Payments in 2016 2015
2016 will present more changes in fair market value (FMV) regulations. Gauging the impact of regulatory changes on compliance and KOL management teams’ FMV rates requires a market-by-market analysis. From the United States to the United Kingdom, and parts of South America and Southeast Asia as well, governments are increasing their monitoring of the money that drug and device manufacturers spend on physicians. This white paper describes key factors impacting FMV determination worldwide, including the challenges and difficulties involved in developing rates in emerging markets. It also focuses on emerging regulatory trends around the world that influence compliance and medical affairs teams’ ability to apply an updated, uniform methodology to FMV calculation processes.
Sponsor-CRO Relationships: The Benefits and Challenges of Collaborating with 3rd-Party Providers 2015
Contract research organizations (CROs) provide instrumental support for the design and execution-based aspects of sponsors’ clinical research. Many pharmaceutical and device companies recruit CROs to help them overcome a challenging clinical environment. This environment includes growing R&D costs, pricing pressures and evolving regulatory guidelines. This paper provides a glimpse into sponsor and CRO relationships, including what responsibilities sponsors most often outsource, how CROs may help sponsors propel existing clinical strategies, and how these two teams can work together to overcome clinical trial challenges.