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


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


Consider Site Capabilities to Determine Risk-Based Monitoring Strategies

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

Clinical site monitoring is a key consideration for life science companies’ clinical trial timelines and budgets.  Regardless of development phase, the level of planned site visitation — which can take up not only a lot of clinical research associates’ time, but also trial budget — can potentially accelerate or delay trial progress.  While in-person site visits help sponsors identify a number of issues, risk-based monitoring strategies can improve monitoring efficiency and save companies time and money. Continue reading


Trial Master File Management: Laying the Groundwork for Clinical Success Starts with Innovative Strategies

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

Companies traditionally leverage a master file for each of their clinical trials. These master files help them organize trial documents and, consequently, adhere to regulatory standards.  Generally, Good Clinical Practices (GCP) guides what documents companies elect to include in this file.  Additionally, included documents range from those necessary for trial set-up to documents signifying trial completion. For example, companies would need to include materials as trial protocols, feasibility assessments, patient informed consent documents, to name a few. Continue reading


Risk-Based Monitoring (RBM) Defrays High Monitoring Costs during Longer Clinical Trials

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

For most life sciences companies, on-site monitoring is a significant expense during clinical studies.  In fact, one CRO executive interviewed by CEI’s analysts suggests that monitoring budgets — which supports the number of monitors required for the trial and their travel expenses — can equal up to 60% of overall clinical trial costs.  To defray some of these costs, many pharmaceutical companies are turning to risk-based monitoring (RBM) as an effective cost-reduction technique. Continue reading


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


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


Staffing Oncology Trials: An Ode to the CRA

Sarah Ray, staffing oncology trials researcher
By Sarah Ray,
Senior Research Analyst

As investigational drugs and devices move into larger and more complex trials, a growing variety of roles are involved in ensuring that clinical trials continue to run smoothly.  Cutting Edge Information’s oncology trials report focuses on how companies’ staffing roles — including data managers, statisticians and regulatory staffing — evolve to provide key clinical support.   Although each role is significant, the importance of the clinical research associate (CRA) stands out, in the opinion of clinical development executives.  In a word, CRAs are the jacks-of-all trades whose familiarity with trial protocols and previous clinical experience can prove instrumental in the success of a new product’s clinical trials.  Using their knowledge of Good Clinical Practices, CRAs can drive trial progress by facilitating sponsor-site communications and acting in a troubleshooting capacity, should specific challenges arise. Continue reading


Risk-Based Monitoring Strategy: Embrace Centralization Technology to Save Resources During Clinical Trials

Victoria Cavicchi, pharmaceutical clinical trial researcher
By Victoria Cavicchi,
Research Analyst

Risk-based monitoring (RBM) has recently emerged in the pharmaceutical industry as a way to reduce the costs of clinical trials while maintaining, or even improving, site protocol compliance and communication. In traditional trials, sponsors visit clinical sites frequently — often every four to eight weeks. However, these in-person site visits and monitoring strategies account for a large percentage — a suggested 30% — of clinical trial costs.  A risk-based monitoring strategy — especially when combined with in-person visits — conserves time and staffing resources while still enforcing good clinical practices. Continue reading