Trial Financial Management Featured Articles

1. The Real Miracle Of Drug Development: Immunity From Inflation! 2/12/2016

   They say there are two certainties in life: death and taxes. If we were to add a third certainty to that list, it might be that we generally have inflation as well. But if rising prices on consumer goods are a fact of life, why are some people surprised when the cost of prescription drugs increase as well?

2. Six Ways You Can Avoid Malpractice Risk In Clinical Trials 5/2/2013

   When choosing a partner to participate in your human clinical trial, does it matter if you select a state- or federally chartered clinical facility versus a privately operated clinic or hospital? David Shuey, North America life sciences practice leader for insurance brokerage firm Willis Group Holdings plc., believes it does. In fact, if you are not aware of the differences, it could cost you dearly should a problem arise. The issue is sovereign immunity, an ancient carryover from England that is designed to protect the government from lawsuits.

3. Outsourcing Perceptions From The CEO Of An Early Stage Start-Up 4/1/2013

   Leslie Williams is President, CEO, and founder of ImmusanT, Inc., an early stage company focused on peptide treatments for auto-immune diseases. Williams has over 20 years of industry experience in healthcare, management, commercial product development and marketing. Williams took time out from her managerial duties to share her perceptions on outsourcing and working with CROs.

4. The Sunshine Act: Physician Payment Sunshine Provisions 12/18/2012

   The Sunshine Act requires manufacturers of drugs, devices, biologicals, and medical supplies to begin recording all physician payments—including payments made for clinical trial research

5. CROS And The PPSA (Sunshine Act) 10/8/2012

   As a CRO you will be hearing more and more about the Physician’s Payment Sunshine Act or PPSA in the next few months. By James Neal, Endign

6. The Soft Science Of Choosing A CRO 5/29/2012

   Small CROs have had a harder time competing in recent years against the worldwide giants of the field — Quintiles, Covance, PPD, Charles River, ICON, to name a few — in large part because the scary financial environment has prompted pharma and biotech executives to play the safer hand of choosing a large provider to handle their clinical services needs, even when a smaller vendor offers the same services at a competitive price. By Jacquie Mardell, Anhvita BioPharma Consulting

7. 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

8. A Chief Medical Officer's Perspective On Selecting A CRO 5/14/2012

   Santosh Vetticaden, Ph.D., M.D. is a drug development professional with over 20 years of experience spanning large pharma and biotech across multiple therapeutic areas. He has been involved in trials from Phase I-Phase IV and has been extensively involved in the design, planning, and implementation of global trials. By Rob Wright, Chief Editor, Life Science Leader magazine

9. Navigating The New Med/Legal Landscape 5/2/2012

   Imagine you are a physician, and you are concerned about the forthcoming public visibility that will be driven by the Sunshine Act. In the past, you worked with manufacturers on early-stage compounds to assist in the drug development process. Primarily, this was done via participating in a live, weekend advisory board, where you received a total of $1,000 in honorarium for your time. By Lance Hill

10. Streamlining The Workflow of CRCs: Understand the Challenges, Provide Solutions 5/1/2012

    Clinical Research Coordinators (CRCs) play a crucial role at sites in ensuring that research is conducted in a GCP-compliant manner. In many cases, processes could be streamlined to foster greater efficiency and quality in operations. In order to improve the processes, the challenges of current workflows must first be understood.