White Papers

31. Challenges And Opportunities In Clinical Data Management 4/14/2020

    Breakthrough medical interventions are nothing without accurate, comprehensive clinical trial data. Unfortunately, in today’s high-pressured, fast-paced clinical development environment a huge challenge exists with the cleanliness, completeness and quality of clinical trial data. This recent survey of professionals involved in clinical data management at large pharma companies, biotechs, device developers and CROs based around the world provided valuable insight.

32. Impact Assessment Of eClinical Technologies And Industry Initiatives On Sites 4/14/2020

    Sites are dynamic environments, and new technology and industry initiatives are important complements to the critical need for relationship-building and maintenance. But, are these technologies and initiatives helping improve site and sponsor-CRO collaboration and creating a competitive edge through improved clinical trial performance?

33. Clinical Data Transparency & Public Disclosures: Overcoming Challenges With Prospective Writing 4/13/2020

    If a prospective approach is applied while preparing one document, it can support the creation of the other documents at a later stage. In this paper, we will discuss the development of document connections while preparing material for internationally regulated disclosure and how to apply this information.

34. Navigating The Changing Clinical Trial Landscape 4/13/2020

    The only way to map a course to a better future is to understand the reality of the current landscape and what perpetuates the status quo. To do this, insight was gathered from those involved in clinical trials. The output of this research reveals the challenges and priorities that will shape the journey to the future of clinical research.

35. The H1N1 Study: Conducting Public Health Research During A Pandemic 4/7/2020

    This article describes Rho’s involvement in a recent clinical trial that assessed the safety and immunogenicity of the 2009 H1N1 vaccine in adults and children (aged 12-79 years) with severe asthma.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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.