Leverage Centralized Risk-Based Monitoring Tactics to Preserve Data Quality and Highlight Potential Problem Areas

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Since its inception in 2012, the industry group TransCelerate has developed many clinical initiatives, from clinical data standards to site qualification and training.  Each of these ongoing programs is aimed at improving research and development practices across the biopharmaceutical industry.  The group’s risk-based monitoring initiative—also launched in 2012—aims to help life science teams maximize site monitoring outcomes by developing site visit schedules based on potential trial risk.  Continue reading


Pharmaceutical Brand Spending Focus Shifts to Commercialization During Registration and Launch

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Senior Research Analyst

Pharmaceutical brand spending varies dramatically from early-stage brand development to pharma brand launch.  During pre-clinical to Phase 2 clinical trials, brand teams skew support toward medical affairs activities.  However, by late-stage development—and especially as pharma brands prepare to enter the market—brand teams must shift their focus to commercialization efforts. Continue reading



EFPIA Member Companies and Associations Prepare for Transfer of Value Disclosures in 2016

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

With 2016 off to a start, it’s time to take a look at the increasing number of countries requiring life science teams to publicly disclose any payments provided to either physicians or healthcare organizations.  The European Federation of Pharmaceutical Industries and Associations (EFPIA) mandated countries with member associations to adopt its code on disclosing payments made to healthcare professionals and organizations no later than December 31, 2013.  However, the code did not require member companies to begin collecting payment information until 2015.  Life science companies that are EFPIA members began documenting transfers of value as of the first of the year and are set to disclose these payments no later than June 30, 2016.  Continue reading


Life Science Teams’ Use of Electronic TMF Components Remains on the Rise

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

In 2015, Cutting Edge Information researched how global and country-level life science teams balance paper-based and electronic documents within their trial master files (TMFs).  So far, global teams report the highest percentage of electronic documents within their TMFs.   Currently, life science teams at the global level report TMFs that are an average of 54% electronic and 46% paper.  By comparison, surveyed US teams report TMFs that are, on average, only 38% electronic.  Continue reading


Physician Fair Market Value with FMVConnect

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Senior Research Analyst

Determining fair market value (FMV) payments to healthcare professionals for speeches, advisory boards or consulting can be at best a minor effort and at worst a major compliance headache.  FMV rates will vary by the speaker’s country, tier, type of activity and therapeutic area, meaning that teams may have to evaluate different rates for each individual speaker working at a given event.  Life sciences companies can turn to Cutting Edge Information to make FMV evaluations as painless as possible. Continue reading


Building Better Payer Relationships in 2016: Three New Year’s Resolutions for Pharmaceutical Companies

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

It’s January, so right now it feels like everyone around us has made resolutions to get more exercise, eat better, or otherwise improve their lives. In that spirit, let’s take a look at what companies can do to improve their payer relationships in 2016. According to The Wall Street Journal, drug prices are on the rise, so the value propositions of health economics groups will be increasingly important when working with payers. Continue reading


Balancing Clinical Trial Planning and Execution Activities: The Growing Importance of the CRO

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

According to clinical outsourcing research conducted earlier this year, life science teams report varying levels of CRO involvement in their clinical studies. Often, companies seek CRO expertise on the trial execution side of clinical operations.  As shown below, surveyed pharmaceutical and device teams outsource an average of 68% of their data management workloads and 60% of their clinical operations workloads (Figure 1).  Surveyed teams also outsource relatively high percentages of other execution-based activities as well.  For example, surveyed pharmaceutical and device companies outsource an average of half of their non-risk-based trial monitoring activities and roughly 44% of their drug safety duties. Continue reading


Establishing KOL Travel Compensation at Fair Market Value

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Senior Research Analyst

In the course of working with pharmaceutical companies, many key opinion leaders must travel to contribute to advisory boards or speaking events.  As such, firms must determine how to compensate physicians for the time and cost of this travel.  However, there is no industry standard for KOL travel compensation.

Through its fair market value research, Cutting Edge Information talked to several life sciences executives regarding key opinion leader travel compensation.  When working with KOLs, companies’ travel considerations fall into two different categories: Some companies compensate for activities or meeting expenses only while others provide for these expenses as well as travel honoraria. Continue reading


Pharma Companies Focus Pre-Clinical New Product Planning on Medical Affairs Expenditures

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Senior Research Analyst

Pharmaceutical brand spending is a key consideration as commercialization groups begin new product planning.  Life sciences companies must be able to right-size brand support across many functions. Throughout a product’s lifecycle, brand teams must be able to determine budget allocation across medical affairs, market access and marketing expenditures.  In the early stages of new product planning, commercialization groups often focus pharma brand spending on medical affairs activities. Continue reading