The Strategic Alliance is Evolved, Not Dead: Building Meaningful Collaborations Across Sponsor and CRO Structures with a Master Services Agreement

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

Third party providers often provide an invaluable resource for life sciences teams.  These organizations may supplement lean in-house clinical staff and provide additional expertise, regarding patient recruitment and site selection processes.  According to the Association for Clinical Research Organizations, life science companies’ use of CROs has increased by 44% from 2007 to 2011.  However, according to Clinical Outsourcing:  Leverage Sponsor-CRO Relationships to Accelerate Trial Timelines, an upcoming study by Cutting Edge Information, teams may be growing increasingly selective regarding with which CROs they elect to work.  A growing percentage of life sciences teams have begun leaning toward use of strategic partnerships with clinical solution providers. Continue reading



IIT Approval: The Stanley Cup of Investigator-Sponsored Research

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

Like NHL playoff teams vying for the Stanley Cup, investigators submitting IIT proposals are also competing with one another — and the competition is fierce.  In its Investigator-Initiated Trial Management study, Cutting Edge Information found that surveyed life sciences teams received an average of 108.7 IIT proposals in 2014.  Of these proposals, companies evaluated an average of 99.2 of combined concept and protocol submissions and approved an average of 43.5. Continue reading


Proving MSL Team Value: Best Practices from ExL’s MASS East 2015

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

Proving value is a constant challenge for medical science liaisons (MSLs).  Like many medical affairs subfunctions, MSL teams are developing key performance metrics (KPIs) to illustrate their productivity levels to senior management.  Some teams begrudge this task, not wishing to condense MSL’s activities to mere numbers that may or may not reflect the quality of their work.  Still, many teams are building robust, outcomes-based, multifactorial KPIs that get closer to the heart of MSL value.  Continue reading


Schedule Regular Medical Publications Meetings to Guide Strategy Creation

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

Medical publications meetings are a key communication channel between the internal functions contributing to medical studies and those responsible for creating and distributing abstracts and posters. Regular communication equips companies with the information necessary to meet publications deadlines and to achieve publication goals. However, companies may look to various meeting frequency depending on team size and goals. Continue reading


Start Early Enough in Development to Get a PRO Instrument Designed Right

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

As companies work to integrate patient reported outcomes into both pre- and post-launch activities, the importance of a well-designed PRO instrument is increasing. There are a number of internal and external stakeholders for patient reported outcomes data — and this number is expected to grow in the next few years.  HEOR teams, clinical groups, and some commercial teams internally are now more interested in making sure that they have the right PRO endpoints to show to payers, regulators, and physicians. The PRO instrument to collect this information is a key part of this process. Continue reading


Some Medical Device Companies Leverage Clinical Trials to Supplement FDA Submissions and Enhance Marketing Messages Despite Avoiding Necessity to Complete Them

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

The US Food and Drug Administration (FDA) does not require that all medical device manufacturers file clinical findings along with regulatory submissions.  Companies developing medical devices that are similar to other products in the US market can use the pre-market notification 510(k) submission which requires bench and laboratory data, but not full-blown clinical trials. Continue reading


Consider Expected Attendance to Determine Investigator Meeting Budgets

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

Determining clinical investigator meeting budgets is a key component of meeting planning. To determine the meeting budget, companies typically evaluate the number of attendees, reimbursed items and the cost of reimbursed items per attendee. To build more accurate investigator meeting budgets, companies must be able to identify their expected costs during the planning phase. Continue reading


Risk Thresholds: A Key Ingredient to Any Risk-Based Monitoring Plan

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

Risk-based monitoring (RBM) plans are not necessarily a new phenomenon within the clinical space.  However, in recent years, life sciences companies have become increasingly active in their RBM explorations.  Inspired by recent regulatory publications — and under the guidance of non-profit industry group TransCelerate Biopharma — many clinical teams at pharmaceutical organizations have initiated pilot studies to examine the value posed by RBM strategies: from centralized to triggered monitoring practices. Continue reading