Through the Looking Glass: A Clinical Trial from the Patient’s Side

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Data Products Team Leader

Please Treat Me Better Than the Mice.

Here at Cutting Edge Information, we spend a lot of time researching how companies take products from pre-clinical through approval and then support those products once they reach the market. But sometimes a change in perspective is good. So a few weeks ago I enrolled in a Phase 1 clinical trial to see what the process looks like from the patient’s side. While I cannot go into great detail about the specific processes around the trial, I did have some observations for the industry that we all work in. Continue reading


Formalize Trial Master File Training Methods to Emphasize the Value that Dedicated TMF Groups Provide

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

Managing trial master files (TMFs) is more than an administrative function.  Even so, convincing internal teams of the substantive value that TMF functions provide is a challenge that many surveyed life science teams face.  The earlier that companies can prioritize TMF activities, the less likely they are to incur problems during future regulatory inspections. Continue reading


Scientific Affairs at Medical Device Firms: The Ongoing Challenge to Define Roles

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

Scientific affairs has evolved into a highly visible function throughout the life sciences industry. Companies look to these functions as the liaison between clinical-focused groups and the healthcare community.  However, some medical device organizations’ scientific affairs groups face ongoing challenges in defining their specific roles within the company.   Continue reading


Developing a Launch Sequence: Should Teams Build from Scratch or Repurpose Existing Sequences?

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

A product’s overall success may often depend on how well it does in its initial market debuts, meaning it is critical to launch the product first in markets where it is likely to succeed.  Teams develop a product launch sequence as a roadmap for when a product should reach particular markets.  These launch sequences typically take place in three waves, beginning with the most critical markets for the first wave and ending with the riskiest and/or nonessential markets in the third wave. Continue reading


Are all Patient Centered Outcomes Created Equal?

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

Patient centered outcomes, including patient-reported outcomes (PROs), may be as generic or disease area-specific as the PRO team would like.  As with any choice, however, there many factors to consider when deciding what type of patient centered outcomes instrument to use.  For instance, teams that custom-design specific PRO tools may have very targeted and relevant data for their products.  Continue reading



Benefit-Risk Profiles: Pharmaceutical and Device Products’ Electronic Medical Records

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

Benefit-risk analyses help life science teams compare identified safety concerns with product efficacy outcomes.  Often, life science teams begin constructing risk-benefit profiles while products are in the preclinical or early clinical development stages.  After establishing their initial profiles, teams will update risk-benefit information as new data becomes available.  Much like patients’ medical records, products’ benefit-risk profiles remain associated with them for life. Continue reading


Companies’ Experiences with KOL Contract Negotiations Are Changing

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Data Product Team Leader

Pressure on groups working with HCPs and other thought leaders has increased over the past five years with the rise of the Sunshine Act in the US and increased regulatory scrutiny around the world.  CEI has conducted extensive research on how companies should compensate thought leaders and what represents fair market value in the current healthcare landscape.  We are going to be leading a webinar on Thursday, May 19th at 2:00pm Eastern time to discuss a range of topics associated with KOL engagement by pharmaceutical companies. Continue reading


Managing Time and Cost of Health Technology Assessments

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Data Product Team Leader

As pharmaceutical companies continue to work to prove the value of their products to payers around the world, they are encountering health technology assessments (HTAs) in many markets around the world. These HTAs require companies to submit value dossiers that follow specific guidelines — often including health economics and comparative effectiveness work.  Our research has shown that different HTAs consume varying amounts of raw resources in terms of working hours and budgetary expenditure.  However, most companies’ proportions of timing and spending following similar patterns across regions and company types.  Continue reading


Right-Size Clinical Trial Monitoring Activities by Evaluating Individual Site Data

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

Clinical trial monitoring – or risk-based monitoring (RBM) – is a highly individualized practice among life sciences companies.  Each organization’s clinical trial team may have a different threshold of risk with which they are comfortable.  Teams also employ different mixtures of remote and centralized monitoring techniques. As such, firms must continually evaluate incoming data for factors that indicate a need for increased risk-based monitoring activities. Continue reading