Using Standard Operating Procedures to Prepare for TMF Regulatory Audits

Carson Hurt, Research Analyst
By Carson Hurt,
Research Analyst

To document the progression of clinical studies conducted on a product, clinical trial teams are required to maintain a trial master file (TMF).  These files serve not only as a helpful means to promote accountability among team divisions but also as a box for regulatory agencies to check off during the product approval process.  Regulators take TMFs very seriously, and, as a result, many teams find that managing them properly can increase the probability of a successful regulatory audit.  Common trial master file management problems that can jeopardize audit results include missing or unnecessarily repeated documents — especially those outlining the breakdown of team and CRO responsibilities in the trial.  To mitigate the risk of failed regulatory audits, teams employ quality control teams to review trial documents prior to inspection.  These teams utilize standard operating procedures (SOPs) to guide their TMF inspection process in preparation for auditing.  Recent Cutting Edge Information research reveals that the vast majority (72%) of surveyed teams utilize standard operating procedures in TMF quality control (Figure 1).

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Start Relationships Early to Best Meet Payer Requirements

Carson Hurt, Research Analyst
By Carson Hurt,
Research Analyst

For market access teams, forming relationships with payers is a crucial step towards building a winning product value story. According to a recent Cutting Edge Information study, the vast majority of market access teams — especially US teams — are involved in payer relationships. Ninety-four percent of surveyed US teams are assigned to build and maintain relationships with payers (Figure 1). However, beginning relationships early in the product launch window can make a big difference for teams trying to understand and meet payer requirements.

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Optimizing Brand Profile Spending Distribution: Increase Late-Stage Development Resources to Improve Post-Launch Commercialization

Matthew Doscher, Research Analyst
By Matthew Doscher,
Research Analyst

By Phase 3, practically all of a pharmaceutical company’s operations have begun preparing for the product launch. As a product nears marketing entry, the brand profile often includes a broad spectrum of launch activities. Each department has numerous responsibilities including thought leader engagement for medical affairs, pricing negotiations for market access and product label preparation for commercial teams. Appropriately distributing funds among all aspects of the brand profile is crucial for successful commercialization after a pharmaceutical brand launch.

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Outsourcing Can Play a Key Role in Market Access Staffing

Carson Hurt, Research Analyst
By Carson Hurt,
Research Analyst

Outsourced staff can bring valuable expertise to market access teams and help in-house personnel manage activities during the busiest periods of a product’s lifecycle.  Small companies, especially, tend to rely on third-party vendors to fill gaps in market access staffing.  Their teams are generally smaller than large company market access teams.  As such, small teams may have many capability gaps that outsourced staffing can fill.  This is especially true for product pricing and launch sequencing.  These activities usually reach their peak near product launch, overwhelming already busy small company market access teams.  For these teams, outsourcing pricing and launch sequencing activities to third-party vendors can take pressure off of over-extended staff.

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Strategic Account Management: Collaborations Between KAMs and Other Internal Groups

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

Strategic account management entails interacting with every level of the target organization.  While a company’s sales reps interact with hospital specialists, for instance, key account managers (KAMs) may meet with higher-level individuals in the hospital system.  This layered approach ensures that the company builds relationships personnel both on the ground and at the higher organizational levels.

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Understanding Appropriate Systems for Managing KOL Compensation Exceptions

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

For most teams that engage with thought leaders and other HCPs, the emphasis is typically on documentation and consistency.  And for good reason – regulatory audits are much easier to manage when processes are clearly explained and explicitly stated. However, for every rule there are compensation exceptions, and companies should build contingencies for this into their policies.

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Value Assessment: Determining ROI of Patient-Centric Marketing Initiatives

Matthew Doscher, Research Analyst
By Matthew Doscher,
Research Analyst

It can be very difficult to gauge the benefits of patient-centric engagements and marketing programs. Calculating ROI can prove difficult due to complications when collecting “hard” commercial metrics, such as change in sales. In fact, 41% of surveyed teams do not measure ROI for their initiatives. If the initiatives focus more on medical affairs or patient access, measuring ROI may not be possible.

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The Values and Vices of Observational Studies in Postmarketing Research

Carson Hurt, Research Analyst
By Carson Hurt,
Research Analyst

Postmarketing studies are becoming more and more common as a means to gather data supporting product effectiveness, health economics and outcomes. Teams seldom collect these data during Phase 3 trials. Consequently, they are turning to late stage studies to gather metrics important to payers. Many teams find observational studies to be a cost-efficient method to gather necessary data. They are however, not without limitations.

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How Brexit Could Change Pharmaceutical Launch Sequencing Plans

Carson Hurt, Research Analyst
By Carson Hurt,
Research Analyst

As uncertainties continue to mount following the recent vote in the United Kingdom to leave the European Union, questions remain about the referendum’s impacts on pharmaceutical launch sequencing decisions. Assuming that the UK does successfully leave the European Union, the future of the country’s medical regulatory system remains in question. Should the European Medicines Agency (EMA) lose its regulatory jurisdiction over the UK life sciences industry, pharmaceutical companies seeking to launch in the British market could face additional regulatory hurdles. This could have an impact on companies’ launch sequencing plans and even jeopardize the UK’s status as a first-wave launch market.

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