Safety/Efficacy White Papers & Case Studies

  1. Critical Success Factors For Clinical Trials Of Immune Checkpoint Inhibitors 3/4/2016

    Oncologists and their patients have had reason recently to be encouraged by the launch of immune checkpoint inhibitors (ICIs) for the treatment of several difficult-to-treat diseases, including metastatic melanoma and non-small cell lung cancer. These novel agents activate the human immune response against antigens expressed on tumor cells, and the science has generated excitement among physicians, patients, the media and researchers.

  2. InVentiv Health Late Stage Research Datasheet 3/4/2016

    In today’s competitive landscape, getting a drug on the market is no longer about meeting clinical trial requirements, receiving regulatory approval and launching the drug. Drug developers need to generate evidence that shows whether a drug works in the real world and the benefit and value it provides to the healthcare system and patient.

  3. SynteractHCR Full-Service CRO Brochure 3/4/2016

    SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.

  4. What The Fitbit Is Helping Pharma Learn About Patients 2/22/2016

    Fitness trackers were popular holiday gifts this year and sales are on the rise. While counting steps and getting fit may be the primary reason consumers are purchasing Fitbits and other wearables, other sensors these devices include, such as heart rate and sleep monitors, could actually help big pharma collect a wealth of valuable data to revolutionize personalized medicine.

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

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

  6. Global Biosimilar Development 5/16/2013

    Inconsistency in nomenclature used for biosimilars has led to confusion in referring to some products.

  7. Switching EDC Platforms To Rescue In-Flight Clinical Trials 5/7/2013

    The decision to switch an EDC platform for in-flight trials is not easy and is fraught with risks. A majority of companies continue to plough forward with higher costs and operational pains due to a failing EDC platform. Read this white paper and learn how Acceliant's low-risk EDC migration can deliver legacy EDC retirement, lower operating costs, and peace of mind for all teams working towards the success of a clinical trial. By Ven Thangaraj, CTO, Acceliant

  8. 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.

  9. 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.

  10. 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.