Site Selection/Study Start Up Featured Articles
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New EU Regulation Set To Drive Clinical Trial Harmonization
7/28/2015
Sponsor companies conducting clinical trials in the European Union (EU) are currently regulated by EU Directive 2001/20/EC, which provides guidance on clinical trial applications and conduct. Unfortunately, Directives always have to be transposed into National law. By transposing, different countries interpret Directives in slightly different ways. Every country has its own national legislation, resulting in different submission requirements, timelines, classifications, and safety reporting. The result of this lack of harmonization is a complicated and expensive trial process.
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How One Bio Company Tackled Its Data Visualization Challenge
7/16/2015
Data visualization is a problem for many life science companies. Being able to visualize reliable data in real-time, and make smarter decisions faster, is vital to delivering speed and quality across clinical trials.
While many companies struggle with quality uncertainty and surfacing relevant data trends, those that specialize in rare diseases have a more unique challenge. With rare diseases, trials are open label (patients and researchers both know which drug is being administered) and non-comparative. By design, personnel have access to data in an unblended way. That provides the opportunity to see actual data as it emerges, enabling personnel to understand the data in a way that would not be possible in a blended trial.
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Quality Of Outsourced Trials: Why Do Disconnects Still Exist Between Sponsors And CROs
7/14/2015
The requirement for quality during the conduct of clinical trials is an absolute; a given that few in the pharmaceutical, biotech, and CRO industries would debate. Yet longitudinal survey data collected by The Avoca Group highlight that disconnects - the definitions of what constitutes quality, alignment on required levels of quality, and success at delivering to these expectations - continue to exist. Business models for designing and implementing clinical trials require that multiple stakeholder organizations (e.g. pharma/biotech, CROs, co-development partners, and regulators) align on and successfully implement to mutually agreed quality expectations.
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Can Small And Midsized CROs Survive In Today's Strategic Outsourcing Environment?
11/5/2014
In today's outsourcing environment, strategic partnerships seem to be the preferred partnering method for many pharma companies. Bayer HealthCare has strategic agreements in place with Covance and INC Research. Pfizer has similar agreements in place with ICON and PAREXEL. But if pharma companies continue to pursue this type of partnering model, will many of the small to mid-sized CROs survive?
SynteractHCR CEO Wendel Barr thinks so. His contract research organization is one that targets the small to mid-sized biotech companies. In many cases, these companies have very little infrastructure in place. They do have experts in-house, but generally that expertise centers primarily on the drug itself. As a result, these companies must rely on their CRO to provide the needed expertise they are missing, be it scientific, regulatory, or project management.
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“Non-Traditional CROs” Find Solutions While Managing Costs
9/30/2013
In the 1970’s and 1980’s pharmaceutical and biotechnology companies started to outsource many of the clinical operations services to organizations that have come to be known as contract research organizations (CROs). “Traditional CROs” established themselves by hiring and training employees to manage and monitor clinical trials. The individuals selected included those preferably with a scientific background and were most often fresh out of college or nursing school. The training they received was essential as they lacked experience in a fledgling industry. Strict supervision was also required based on low levels of experience. CRAs with zero to two years of experience made up the majority of the workforce and it was difficult for Traditional CROs to find CRAs with the requisite experience to appoint to studies. Therefore, many organizations sought to have blended teams of the more experienced monitors (3 or more years), along with ‘green staff’ or very inexperienced monitors (0 to 2 years). Many of these organizations were financially successful using this approach, yet it was significantly inefficient in terms of time and client’s budget.
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The Shifting Geography Of Life Sciences Innovation
5/30/2013
The life science industry is experiencing change at a pace that is forcing companies to examine how they should operate and innovate more effectively.
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Clinical Trials Ontario: Harnessing Its Research Expertise
9/28/2012
As clinical trial placements began to decline after 2008, Ontario became the first Canadian governmental entity to fund an organization to change the clinical trials landscape, Clinical Trials Ontario (CTO).
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Demystifying Fair Market Value
9/28/2012
Confusion exists over the definition of fair market value (FMV) when you ask any biopharmaceutical sponsor or investigative site and this article attempts to demystify some
basic factors related to FMV principles, with the goal of fostering improved understanding and dialogue on FMV issues. -
Executive Insights From A China-Based Biotech On Selecting A CRO
5/21/2012
Coreen Oei, Ph.D. is the SVP of clinical operations and project management at BeiGene. Oei oversees the execution of clinical trials and the development of budgets and project timelines for BeiGene’s clinical portfolio. Prior to joining BeiGene, she spent 10 years at GlaxoSmithKline where her most recent role was VP, Scientific and Clinical Operations in the Virtual Proof of Concept Unit. Oei recently took time out to answer some questions posed to her by Life Science Leader magazine on her approach to selecting a contract research organization (CRO) from the perspective of a China-based biotech. By Rob Wright, Chief Editor, Life Science Leader magazine
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Former CRA Turned Pharma Exec Provides Insights On Selecting A CRO
5/14/2012
Marc Tokars is the Sr. Director of Clinical Operations for Luitpold Pharmaceuticals, a manufacturer of branded and generic pharmaceutical products. Tokars has over 20 years of tenure in the pharmaceutical industry and has been involved in the development of regulatory strategies, clinical trial design, trial conduct, and outsourcing. By Rob Wright, Chief Editor, Life Science Leader magazine