Safety/Efficacy White Papers & Case Studies

1. FDA Expectations For Diversity Inclusion In Clinical Research 5/24/2017

   The trend toward increasing the diversity of clinical trial participants is encouraging, but a continued effort is needed to keep moving in the right direction.

2. Avoid Wasted Trials: One Story Of An Estimated $100M Saved 3/8/2017

   The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information – like genomic profiles – have become critical to submissions for drug approval. Against this dynamic backdrop, the central challenge facing trial sponsors is the need to bring together diverse data sets, draw meaningful insights from them and act quickly to maximize return on investment.

3. Become A High-Performing Clinical Site: Tools For Hospitals, Clinics, And Academic Centers 10/31/2016

   This paper will give you the keys to set up a new clinical site, find the right model, pass the sponsors’ feasibility processes, acquire the right technologies, familiarize yourself with rules and regulations, and successfully mitigate risks.

4. Rare Disease And Orphan Drug Research Brochure 9/29/2016

   While developing drugs to treat rare diseases is more viable from a business perspective than ever before, the clinical research and go-to-market planning process is still fraught with challenges. Regulations, protocols, logistics, and reporting are all different when patients are scarce, the stakes are high, and treatments are complex.

5. Chronic Obstructive Pulmonary Disease (COPD) Research Brochure 9/29/2016

   Respiratory studies—particularly those for COPD—pose extraordinary logistical and clinical challenges for sponsors. INC Research/inVentiv Health, having extensive experience in conducting COPD trials, has developed unique ways to overcome these challenges.

6. Clinical Trials Feasibility And Clinical Informatics Services Brochure 9/29/2016

   At INC Research/inVentiv Health, our ultimate goal is to improve the planning and execution of clinical trials in a cost-effective and timely manner.

7. Autoimmune Disease Research Brochure 9/29/2016

   Autoimmune disease covers a wide spectrum of unmet medical needs.

8. Considerations For Pursuing Accelerated Approval In Oncology Indications 7/28/2016

   For many years, sponsors in the US have been able to apply for Accelerated Approval from regulators based on a surrogate endpoint. This approach is intended to speed products to market that treat serious or life-threatening conditions and that offer a benefit over current treatments.

9. Transforming Clinical Trial Risks Into Results With RBM 6/23/2016

   As the complexity of clinical trial grows, sponsors are increasingly revisiting their monitoring methods to uncover new efficiencies while ensuring ongoing patient safety and data quality.

10. 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.