Safety/Efficacy White Papers & Case Studies

  1. A Comprehensive Named Patient Programme (NPP) That’s Adaptable To Expansion

    Challenge: A biotech company launched a Named Patient Programme (NPP) that required complex and dedicated operational support. The NPP demanded expedited patient eligibility review and urgent drug shipment to an extremely sick patient population. High patient demand from a global population encouraged them to seek a pharma services provider to manage the programme.

  2. Does ICH E6 R2 Effect Risk-Based Monitoring And Overall Quality Risk Management?

    Regulators are encouraging the industry to take a new quality risk management (QRM) approach to clinical trial execution. The latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 R2 guidelines represent the first update to the guidelines in over 19 years.

  3. Clinical Trials Breathe Life Into Standard Operating Procedures (SOPs)

    Standard Operating Procedures (SOPs) have long been fundamental to many industries, and the clinical trials sector is no exception. With the advent of the Good Clinical Practice Guideline in 1996 from the International Conference on Harmonisation (ICH-GCP), stakeholders have been motivated to develop SOPs, not only for regulatory compliance, but also as a routine business practice. Yet, too often, after companies devote significant time and resources into creating SOPs, they may not be followed.

  4. Become A High-Performing Clinical Site: Tools For Hospitals, Clinics, And Academic Centers

    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.

  5. Rare Disease And Orphan Drug Research Brochure

    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.

  6. Chronic Obstructive Pulmonary Disease (COPD) Research Brochure

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

  7. Clinical Trials Feasibility And Clinical Informatics Services Brochure

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

  8. Autoimmune Disease Research Brochure

    Autoimmune disease covers a wide spectrum of unmet medical needs.

  9. Study Startup: The Last Major Frontier In Automating Clinical Operations

    The industry has stepped up with various cloud-based solutions such as clinical trial management systems (CTMS), electronic data capture (EDC), and the electronic trial master file (eTMF)—all quantum leaps—yet lengthy cycle times, lasting nearly seven years,1 are still commonplace. A key reason is that they do not address the one part of a study’s lifecycle that strongly impacts the overall timeline of clinical trial conduct—study startup (SSU). As more stakeholders acknowledge that better SSU processes are essential for shorter clinical trial timelines, SSU has become the last major frontier in clinical trial automation, the final holdout where spreadsheet methodology still looms large, and where innovation is making a resounding difference.

  10. Considerations For Pursuing Accelerated Approval In Oncology Indications

    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.