Newsletter | March 20, 2013

03.20.13 -- Getting to Phase I, Oncology Trials, EDC, And IVR Set-up Tips

Outsourced Pharma Newsletter
Preclinical Development Clinical Development Discovery Research Logistics
Featured Focus: Preclinical Development
How Do I Get My Compound Into Phase I?
By Dr. Scott E. Boley and Greg Ruppert, MPI Research
The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials.
ARTICLE: When Outsourcing, Focusing On Low FTE Rates Can Be Costly
By Roger Frechette, cofounder and partner, New England PharmAssociates, LLC
When selecting a CRO, you get what you pay for. A low-cost contract research partner may require you to do the work twice.
» Clinical Development
ARTICLE: Covance Advances The Role Of Central Labs In Oncology Trials
By Wayne Koberstein, Covance, Inc.
Testing drives drug development. From laboratory tests on patients’ blood, tissue, and waste products comes almost all the clinical data needed for a new drug application. How and where those specimens are collected, transported, stored, and analyzed can have a huge impact on the quality and usefulness of the data they produce.
ARTICLE: Electronic Data Capture And IVR Study Setup Tips For Clinical Trials
By Jennifer Price, Director Of Clinical Solutions, BioClinica
While they offer sponsors the ability to run faster, more efficient clinical trials, using an Electronic Data Capture (EDC) or an Interactive Voice/Web Response (IVR/IWR) system can be a challenge for any sponsor.
ARTICLE: Impact Of Questionnaire Layout On Patient Responses
By Paul O'Donohoe, Manager Health Outcomes, CRF Health
There are many things to consider when developing a questionnaire, however, an element that is often overlooked is the actual layout of the questionnaire. For sure, great importance is given (or should be given) to ensuring that the questionnaire is easy on the eye and intuitive to follow; but how do these decisions impact the perception of the user?
WHITE PAPER: Sponsor And CRO Pharmacovigilance Alliances: Best Practices To Ensure Success
By Dr. Sabine Richter, PRA
The benefits of outsourcing in general also hold true for pharmacovigilance services. Fixed resource costs are converted into flexible, workload-oriented costs. In the outsourcing model, pharmaceutical and biotech companies reduce costs because significantly less effort is needed for recruitment, management, and training of staff.
PRODUCT: This Is NOT Your Sponsor's CTMS
By Brian Wulff, Business Development Manager, Forte Research
Sponsors do have their own CTMS or EDC systems, and sites log into them to enter clinical data for a given sponsor or trial. But none of these systems belong to the site, and none are devoted to the business operations of the site across all studies.
» Discovery Research
ARTICLE: Unlocking Brain Tumor Biology: Covance's Genomics Laboratory And The Institute For Systems Biology Begin To Unravel The Genetic Mechanisms Of Gliobastoma Multiforme
By Anup Madan, Ph.D., and Sergey Stepaniants, Ph.D., Covance, Inc.
In March 2011, Covance’s Seattle-based Genomics Laboratory (CGL) collaborated with the Institute for Systems Biology (ISB), also based in Seattle, to collectively unravel the complex regulation of gene expression in Glioblastoma Multiforme (GBM), one of the most common and aggressive forms of brain cancer.
» Logistics
Q&A: Overcoming Obstacles That Face The Pharmaceutical Supply Chain
Executive Q&A: Richard Beeny, Cofounder and CEO of LifeScience Logistics
Richard Beeny is Cofounder and Chief Executive Officer of LifeScience Logistics. In this Q&A, Beeny addresses some of the obstacles that face today’s supply chain and gives advice on how to best combat those challenges.
ARTICLE: Track/Trace Solutions For The Logistics Supply Chain
CASE STUDY: Major Insulin Manufacturer Gets Help Moving Its Distribution Center From New Jersey To Indiana
CASE STUDY: How DSC Helped Bristol-Myers Squibb Satisfy Customers With Customized Service