EDC/Data Management White Papers & Case Studies
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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.
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33 Questions To Ask Before Buying Data Management Software
4/30/2013
While choosing the wrong product is never a good idea, when it comes to clinical trials software, the wrong product could be disastrous for your company.
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Global Pharmacovigilance And Safety Solutions
4/23/2013
As the world’s largest privately held provider of global communication and technology solutions to the life sciences industry, TransPerfect offers an end-to-end solution to handle all aspects of pharmacovigilance and safety management in over 170 languages.
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CFS Clinical Helps Top 20 Pharma Improve Investigator Payment And Budget Management While Addressing Sunshine & FMV Compliance
3/19/2013
Like its peers of all sizes operating in the United States, this Top 20 Pharma has faced the challenge of anticipating and addressing the Physician Payment Sunshine Provision (PPSP) within the Patient Protection and Affordable Care Act (PPACA) of 2009. Presented By Jim DiCesare, VP and General Manager, Contract and Regulatory Services
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CoSign Signature API (SAPI®) Brochure
3/5/2013
Signatures play a crucial role in our day-to-day lives. Organizations understand that paper processes are expensive and are looking to migrate from a pen on paper signature (wet signature) to a true paperless environment.
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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.
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Accelerating Preclinical Studies With Project Tracking And Optimization Software
2/13/2013
A large pharmaceutical company with globally distributed preclinical R&D operations including externalized services implemented an advanced assay/ study tracking and optimization system in conjunction with its enterprise electronic lab notebook.
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Improve Investigator Payment and Budget Management While Addressing Sunshine & FMV Compliance
2/11/2013
Like its peers of all sizes operating in the United States, this Top 20 Pharma has faced the challenge of anticipating and addressing the Physician Payment Sunshine Provision (PPSP) within the Patient Protection and Affordable Care Act (PPACA) of 2009. By CFS Clinical
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Phase II Primary Insomnia Program In Need Of Full-Service CRO Management
12/6/2012
Clinilabs, a contract research organization (CRO), was selected by an international drug discovery and development company to provide full-service CRO management of a phase II primary insomnia program.
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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).