GUEST COLUMNISTS

CLINICAL TRIAL WHITE PAPERS

  • Basket Clinical Trial Designs: The Key To Testing Innovative Therapies Is Innovation In Study Design And Conduct

    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.

  • ePRO And Agile Methodology: A Winning End-to-End Solution For Oncology Studies

    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.

  • Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring

    Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

  • Mitigating Inherent Risks In Global Sample Processing

    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.

  • Maximizing Success In Early Stage Oncology Trials: Considerations And Strategies In The Era Of Molecularly Targeted Agents

    Making a meaningful impact on the survival and quality of life of patients with cancer remains a significant challenge. This white paper discusses considerations and strategies for maximizing the likelihood of success in early phase oncology trials and developing significantly improved therapeutics for patients.

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • A Multiple Sclerosis Clinical Trial Collaboration

    Managing multiple outcome measures and rapid patient recruitment for Phase IIB clinical trial on targeting relapse-remitting Multiple Sclerosis

  • Regulatory Inspection SOP Checklist: How to Prepare for an Inspection

    A best practice for inspection preparation is a standard operating procedure (SOP) that codifies the roles, procedures, and training your organization will enact in preparation for an announced inspection.

  • Adopting Label Change Best Practice To Promote Clarity And Compliance

    Globalized clinical trials are quickly becoming a pre-requisite for success. Read Almac’s latest case study to learn how one sponsor was able to extend its trial into new countries without risking labelling non-compliance, which enabled them to continue on their mission to improve the health outcomes for millions of patients.

  • FDA Inspections Need Not Be Stressful

    As a stakeholder in a research facility the prospect of an inspection by the US Food and Drug Administration (FDA) may elevate your blood pressure and induce feelings of panic. But according to Dr. Harvey Arbit, "the FDA inspection process should go quite smoothly if you're doing everything right." Still nervous? Don't be.

  • Fast Track To Flexible Clinical Trials

    So, about that clinical trial running right now. In several countries. Clinical setting required. Hmm. We at ISR are speculating that sponsors are shopping around for providers who can adapt, and adapt quickly, to current times. We know that outsourcing is already a challenging undertaking – which CRO is best-suited to conduct a given trial? Who will perform the best? These are loaded questions in normal times, and we provide the reliable data needed to tackle them. Every year we survey hundreds of clinical development outsourcers to share their perspectives and experiences regarding CRO selection and performance evaluation. Did we have the foresight to ask about trial adaptability in the face of a global pandemic? Unfortunately, no, but some findings suggest change is coming.

  • Solution For Independent Data Monitoring Committee Services

    Client turns to this CRO when they needed a team experienced with the full range of IDMC activities to provide a seamless solution.

CLINICAL LEADER CONTENT COLLECTIONS

19_07_CL_RealWorldEvidenceEbook_300x200

 

In this eBook, we take a close look at Real World Evidence. What is it, how is it being used, why all the hype over it, and how the use of RWE is bringing together the worlds of pharma R&D and healthcare. But more importantly, how can we best tap into the data we have available to us today to improve clinical studies and healthcare in the future. Our experts include executives from Bristol-Myers Squibb, Pfizer, the University of Southern California, and Harvard Medical School.

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