Phase IV White Papers & Case Studies

  1. Late Stage Clinical Research Services Brochure 9/29/2016

    As a result of our holistic approach to Late Stage clinical programs and with our expertise in Product Life Cycle Management, INC Research/inVentiv Health is strategically positioned to collect real world, differentiating product evidence that can prepare our clients to more successfully go to market.

  2. Commercial Regulatory Approval And Market Adoption Expertise Brochure 9/29/2016

    We’ve invested in a strategic mix of proprietary services and infrastructure that offers each client customized solutions through a singular team to thrive in the new market reality.

  3. Commercialize Oncology & Hematology Services Brochure 9/29/2016

    At INC Research/inVentiv Health, we are reinventing the way our oncology clients commercialize products to optimize performance, reduce risk, and expedite the delivery of healthcare innovation to patients worldwide. In the last five years, we have conducted over 250 full-service oncology programs in more than 65 countries.

  4. Commercial Regulatory Approval And Market Adoption Expertise Brochure 9/29/2016

    We’ve invested in a strategic mix of proprietary services and infrastructure that offers each client customized solutions through a singular team to thrive in the new market reality.

  5. Top 10 Questions To Ask Your Clinical Supply Vendor About Temperature Sensitive Drugs 6/13/2016

    When conducting trials of biologics, the number of considerations to evaluate within the clinical trial supply chain can be daunting. Keeping investigational products at the right temperature and environmental conditions takes careful coordination of resources and, when required, tight integration with an experienced vendor.

  6. 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.

  7. Quality Assurance: Investigation Trials & Postmarketed Projects Phase I-IV 6/10/2014

    The function of Chiltern’s independent QA auditing group is to assess, for investigational trials or postmarketed projects (Phases I-IV), the state of compliance with ICH-GCP and/or applicable regulatory requirements, Standard Operating Procedures (SOPs), the study protocol and/or project plans.

  8. Expediting Companion Diagnostic Development Through Collaboration 1/2/2014

    August 2011 cemented a remarkable two months for companion diagnostics, with the FDA posting draft guidance on companion diagnostics in July and then approving two cancer drugs and their accompanying tests weeks later. Zelboraf® and the BRAF mutation test for patients with metastatic melanoma were approved August 17, and Xalkori® and the corresponding Vysis ALK Break Apart FISH Probe Kit, which detects gene rearrangements, were approved just nine days later.

  9. Avoiding The Gas-Guzzler: 8 Steps To More Productive Observational Studies 6/17/2013

    When it comes to the subject of research studies, and specifically to observational, non-interventional studies. Suffice it to say that our industry needs to retool in order to cost-effectively respond to the need for these unique types of studies. By Jeff Trotter, Executive Vice President, Phase IV Development

  10. Sourcing For Savings Case Study 5/29/2013

    To help the client overcome these challenges, INC Research/inVentiv Health formed a strategic partnership with the biopharmaceutical company and took over responsibility for all of its trial-level clinical data management activities in the United States.