Developing Successful Patient Recruitment Strategies Means Never Underestimating the Value of Market Research

Sarah Ray, clinical trial patient recruitment strategies researcher
By Sarah Ray,
Senior Research Analyst

Historically, clinical development sponsors — along with trial sites and CROs — have struggled to recruit sufficient numbers of patients for their studies. In some cases, this challenge owes to a sudden influx of trials that target the same patient groups. For example, more than one pharmaceutical executive has worked with sites that are running concurrent studies — each with similar enrollment criteria. In others, problems recruiting sufficient participants boils down to an inability to cater patient recruitment strategies to patient perspectives. Continue reading


Medical Science Liaison Training: Keeping Up with New Research and New Regulations

Natalie DeMasi, medical science liaison training researcher
By Natalie DeMasi,
Research Analyst

No thought leader management team is complete without a process for medical science liaison training.  Medical science liaisons (MSLs) tweak their knowledge and practices in response to constantly evolving compliance regulations and continuous clinical research.  But, MSLs don’t go it alone.  Companies offer MSLs training to help them keep up with the latest regulations and research.  Perhaps most importantly, medical science liaison training allows a company to standardize MSL processes across its widespread teams. Continue reading



All Hands on Deck: Assembling Teams for Medical Device Commercialization

Victoria Cavicchi, medical device commercialization researcher
By Victoria Cavicchi,
Research Analyst

When medical device companies — especially smaller start-ups — begin developing new products, it’s all hands on deck.  Most medical device commercialization teams expect their new products to face some competition in the US market; in fact, Cutting Edge information found that just over 30% of surveyed device firms expect high competition levels at launch.  To ensure successful medical device commercialization, companies call on the expertise of stakeholders throughout the organizations to contribute to strategic planning and market research. Continue reading


Three Steps for Calculating FMV Investigator Compensation

Natalie DeMasi, FMV investigator compensation researcher
By Natalie DeMasi,
Research Analyst

In recent years, regulatory policies dictate that life sciences companies must pay physicians fair-market value (FMV) payments.  But, regulatory guidelines offer no rule book for how to calculate FMV.  This situation — however dire it may seem — actually offers companies a tabula rasa for establishing the best methods for FMV calculations.  While pharma continues to build its own guidelines for FMV, there are three broad steps for determining FMV investigator compensation: Continue reading


Keep Health Economics Groups Out of Information Silos

Jacob Presson, health economics groups researcher
By Jacob Presson,
Senior Research Analyst

One of the major organizational challenges presented by health economics groups is the fact that they need data from the clinical and scientific side of the organization in order to make an effective case for payers that may be used to speaking with the commercial side of the company.  This issue is part of why many health economics groups report into medical affairs so that they can preserve their scientific expertise and credibility while bridging the gap to payers as needed. Continue reading


Strategic Pricing Lifecycle Management Strategies: If You Can’t Beat Generics, Then Join Their Pricing Scheme

Natalie DeMasi, portfolio and lifecycle management researcher
By Natalie DeMasi,
Research Analyst

Pharmaceutical lifecycle management strategies have changed in the past decades.  In the old days of industry lore, companies could roadblock generic market intrusion by conducting clandestine laboratory tests and sending letters to FDA pointing out flaws in the generic’s bioequivalence – just to list one colorful example.  But those days are past.  Today, pharma companies will have better success countering generics with strategic pricing techniques.

Generics often toll the death knell for branded drugs because of their low price.  Since companies can’t beat generic prices, they might as well join them by lowering the price or offering rebates of their branded drugs at the entrance of generics.  A recent study by Cutting Edge Information found that 40% of surveyed companies with strategic pricing utilized these strategies to slow market share decline after exclusivity loss (Figure 1). Continue reading


What’s New in the World of Risk Monitoring Strategies?

Sarah Ray, risk-based monitoring strategies expert
By Sarah Ray,
Senior Research Analyst

Well over a year ago, the industry group TransCelerate released its original risk-based monitoring (RBM) position paper.  The paper provided a series of insights regarding off-site monitoring approaches.  Each of these strategies hinged upon the concept of quality by design (QbD) in which trial designers leverage efficient risk identification, monitoring and mitigation practices to uphold patient safety and data quality in each of their clinical studies. Ultimately, TransCelerate leveraged its paper to emphasize the flaws in companies’ existing risk monitoring strategies — from the lack of sufficient risk-characterization tools to companies’ extensive use of source data verification (SDV).  Since May 2013, the industry has been abuzz with the best ways to implement RBM and overcome stigmas associated with not conducting 100% SDV. Continue reading



Medical Publication Strategies Start with Compliant Teams

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

Medical publications remain an important consideration for companies’ dedicated and non-dedicated medical affairs staff. Earlier this year, Cutting Edge Information conducted a study examining companies’ guiding medical publication strategies and their annual output patterns.

Figure 1 shows that the highest percentage of surveyed companywide, business unit and country-level teams ranked the following as extremely relevant publication goals: Continue reading