Trial Financial Management White Papers & Case Studies

1. New Molecular Entities (NMEs) - The Path Of Resistance 5/3/2013

   On a global scale, the number of new molecular entities (NMEs) in development—and, more importantly, the number being approved by regulatory authorities— has dropped significantly in recent years.

2. Moving Towards An Electronic Environment In Clinical Trials 5/3/2013

   With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.

3. Improving Life Science Operations With Digital Signatures eBook 2/27/2013

   Today, 8 of the top 10 pharmas and 6 of the top 10 CROs use ARX’s CoSign® digital signature solution to help them benefit from fully electronic regulatory document lifecycles, compliance with various FDA GxP regulations, and efficiency in supporting audits.

4. Investigative Site Improves Financial Management Of Clinical Trials 11/2/2012

   eStudySite is a San Diego-based enrollment and research organization that provides inpatient and outpatient clinical research services to pharmaceutical and contract research organizations (CROs).

5. Academic Medical Center Improves Financial Management Of Clinical Trials 11/1/2012

   The Wayne State University School of Medicine is the nation’s largest single-campus medical school. Located in the Detroit Medical Center among specialty hospitals and research centers, the School of Medicine offers an ideal venue for both learning and research.

6. Clinical Trials Business And Financial Management Services Brochure 9/5/2012

   CFS Clinical is the only company to offer turnkey business and financial management services for clinical trials. We help CROs, biopharmaceutical sponsors, and medical device companies to address today’s complex management challenges.

7. Contract & Regulatory Services Brochure 8/29/2012

   With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones—including drug shipment, IRB approval, and patient randomization—can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents.

8. Global Payment Services Brochure 8/29/2012

   Biopharmaceutical and medical device companies rely on investigative sites to complete their clinical trials. Building strong relationships with high-quality sites is critical to addressing a number of key challenges – from the growing number of trials to mounting pressures to minimize cycle times. Yet investigative sites increasingly denounce unrealistic payment schedules and inefficient payment processes as not only frustrating but also threatening to their financial viability.

9. The Sunshine Act: What Sponsors And CROs Should Know 3/27/2012
   There was a lack of concentration and information on HCP Aggregate Spend (the Sunshine Act and PPSA are other terms used to describe it) at the annual Partnerships in Clinical Trials conference in Orlando. It was as if the whole industry is ignoring the issue hoping it will simply disappear.
10. Advancing Vaccine Development 5/11/2011
    With extensive experience in vaccines development, as well as market access and commercialization strategy, Quintiles is uniquely qualified to be your ally in vaccines.