Clinical Monitoring White Papers & Case Studies

  1. Regulatory Approval Of Clinical Studies In The Netherlands 5/16/2013

    The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands. 

  2. End-To-End Management Of Clinical Trials Data 5/16/2013

    The introduction of electronic data capture (EDC) systems in clinical trial data management and analysis triggered the promise of better-managed clinical trials – with greater efficiency, faster access to higher-quality clinical data and better mapping of data flows to business processes.

  3. Beyond EDC: Resolving Data-Entry Challenges Faced By Electronic Data Capture Systems In Clinical Trials 5/8/2013

    Electronic Data Capture (EDC) systems have swept the Clinical Trials industry in recent years, promising to transform the drug development process.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Overcoming Clinical Challenges In Metabolic And Cardiovascular Disease With Metabolomics 4/10/2013

    Metabolic diseases (e.g. obesity, type 2 diabetes, and hypertension) are a rapidly expanding health care concern. Although there is a high demand for novel therapies, the challenges are substantial as existing drugs typically fail due to lack of efficacy or safety, and clinical studies often extremely large and protracted. 

  9. 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.

  10. PiKo® Monitors Brochure 4/27/2012

    Ideal for clinical trials, PiKo® Lung Health Monitors deliver lung function measurements not traditionally available through home monitoring.