White Papers

41. ICH GCP E6 (R2): A Primer For Small Biotech And Specialty Pharma Companies 3/30/2020

    With recent updates to the ICH Good Clinical Practice guidelines biotech and specialty pharma innovators face even greater sponsor responsibilities, the most significant of which may be design and development of Clinical Quality Management Systems to achieve compliance with the revised guidelines. In this white paper, we will explore the revised guideline and discuss its impact on small biotech and specialty pharma sponsors, with a focus on risk-based approaches to quality management.

42. Breakthrough Therapy Designation And Accelerated Approval With Inadequate CMC Program Development: Hurry Up And Wait 3/26/2020

    This article examines the development and marketing application review processes for the chemistry, manufacturing, and controls (CMC) aspects of products targeting serious conditions in the context of the FDA’s expedited accelerated approval (AA) and breakthrough therapy designation (BTD) programs.

43. Mitigating Inherent Risks In Global Sample Processing 3/19/2020

    The global demand for specialized sample processing has grown dramatically however despite the rising need, research teams continue to struggle to obtain high-quality laboratory support services to perform sample processing. Learn how innovative flow cytometry fast turnaround and monitored, specialized processing can help safeguard samples.

44. ePRO And Agile Methodology: A Winning End-to-End Solution For Oncology Studies 3/9/2020

    In oncology clinical research, patient reported outcomes (PRO) have historically been collected on paper. This white paper describes a unique, agile ePRO deployment methodology used by a global clinical trial technology company, discusses the benefits of using ePRO in oncology trials, and explains why this agile process is beneficial for oncology trials.

45. Successful BYOD In Any Phase 3/6/2020

    The idea of BYOD for use in clinical trials during any phase has historically been conceptualized as a futuristic alternative, rather than what it actually is — a viable option for many clinical trials. While there has typically been hesitance among sponsors and CROs to choose a BYOD model for their study, there is an increasing number of trials that have successfully deployed this model with great results. Read more about the Advantages and Misconceptions of BYOD and what you should consider if you are deciding whether BYOD is an option for your study.

46. Approach Your Risk-Based Monitoring Strategy With Confidence 3/6/2020

    As the size, number, and complexity of clinical trials continue to grow, the standard approach to monitoring — a resource-intensive approach involving regular site visits and source document verification (SDV) — has become costly and is no longer realistic. However, the fundamental principles — protection of participants and assurance of data quality — remain paramount. Implementing an RBM strategy at your organization does not need to be complicated. This paper outlines several key strategies that will allow you to confidently develop an effective RBM approach in your clinical research program.

47. Basket Clinical Trial Designs: The Key To Testing Innovative Therapies Is Innovation In Study Design And Conduct 3/4/2020

    As the science behind therapeutic interventions has deepened and grown, the clinical trial designs through which those interventions can be best tested have evolved as well. To study therapies directed against specific abnormalities, in cancer for example, it may make sense to include anyone with the target abnormality in the trial population, regardless of the location of their cancer.

48. Infectious Disease Challenge Studies: Ethical Issues In Causing Disease For Medical Knowledge 3/3/2020

    Infectious Disease "challenge" studies are ones in which healthy participants are intentionally infected with pathogens in order to investigate the cause, prevention, and treatment of infectious diseases- but are they ethical? These studies, while useful, pose ethical concerns, and numerous criteria must be met for an infectious challenge to be ethically permissible.

49. Five Easy Investigator Payment Fixes To Improve Site Relations 3/3/2020

    Investigator payments have long been a challenge for both sponsors and sites because the process is complex, fragmented, lacking in transparency and without standardization. Site satisfaction is closely linked to the frequency, accuracy and timeliness of payments. This white paper reviews five common issues that delay site payments and offers recommendations to resolve these issues, improve payment efficiencies, and ultimately site satisfaction.

50. Developing Analgesia Studies: Use Of Placebo Control In The EU 2/25/2020

    There is longstanding debate on the use of placebo control in clinical trials. This white paper reviews the regulatory, ethical, cultural, and even financial considerations surrounding the issue of placebo control in analgesia clinical trials.