White Papers

1. Special Considerations For Pediatric Trials 4/1/2020

   Clinical research with minors poses several significantly different issues than research conducted on adults. Therefore, researchers must address a number of special considerations when conducting any pediatric clinical trial.

2. Managing Conflicts Of Interest In Clinical Research 4/1/2020

   Managing conflicts of interest in clinical research is a critical mission for many reasons.Here we discuss the need for conflict of interest policies, examine the role of an IRB in managing conflicts of interest, and review key elements an IRB’s policy should include.

3. Tips For Submitting Expedited Review Studies 4/1/2020

   Becoming familiar with the expedited requirements is a good way to ensure you can navigate the review process effectively. Set yourself up for success by reading 6 tips for submitting research studies for expedited review.

4. The Convergence Of GDPR, The HIPAA Security Rule, And Part 11 On U.S. Clinical Research 4/1/2020

   As electronic research systems are increasingly relied upon to store participant data, report results, and confirm informed consent, regulatory bodies around the world are re-examining old regulations and developing new ones. Discover what it means for US research.

5. Botanical Medicines In Research 4/1/2020

   Botanicals have been used for millennia to combat illness—but why are there so few clinical trials testing the merits of this modality? This white paper describes rationale for why IRBs should embrace botanical medicine protocols.

6. 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.

7. 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.

8. Clinical Relevance Of Measuring Resting Heart Rate 3/20/2020

   Resting heart rate may change with age and has been identified as both a risk factor and a modifiable treatment outcome, especially in lifestyle related chronic disease. Monitoring RHR and prevention of long-term increases in RHR may aid to reduce the risks of adverse health outcomes. Read how heart rate monitoring is a clinical parameter that can be simple to measure, easy to collect and interpret, and involves low costs.

9. 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.

10. 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.