GUEST COLUMNISTS

  • 5 Actionable Steps To Expedite Clinical Trial Agreements
    5 Actionable Steps To Expedite Clinical Trial Agreements

    Clinical trial agreements have been notorious for delaying study start-up. This challenge remains even as different players in the industry strive to speed up clinical trial agreement finalization through efforts such as standardization of clinical trial agreement templates and the adoption of contract automation tools.

  • SOP Remediation: When Reinventing The Wheel Is The Best Approach
    SOP Remediation: When Reinventing The Wheel Is The Best Approach

    There is a growing industry focus on standard operating procedure (SOP) remediation. Although outsourcing, mergers, and acquisitions have been in play for the last 20 years, these activities seem to be skyrocketing, which is creating quite a few scenarios that drive the need for SOP remediation.

  • 4 Tips For Successful Collaboration With Your EU Qualified Person (QP)
    4 Tips For Successful Collaboration With Your EU Qualified Person (QP)

    Qualified Persons (QPs) are responsible for the certification of clinical trial materials in the EU and therefore are an essential link in U.S. sponsors’ supply chains. Indeed, engaging QPs well before the clinical trial material needs to be certified not only assures a smooth release process and trial start-up but mitigates pitfalls associated with unanticipated technical, quality, and regulatory challenges.

  • Hybrid Decentralized Trials: Using Technology To Create More Patient-Centric Studies
    Hybrid Decentralized Trials: Using Technology To Create More Patient-Centric Studies

    While it is not a new trend, the spotlight on digital innovation has grown brighter over the last year, with executives from all sides of the clinical research industry seeking technology solutions to improve the clinical trial experience for sites and patients alike. It was a recurring theme at this year’s Society for Clinical Research Sites (SCRS) Global Site Solutions Summit, with several sessions that addressed technological advancement and attendee feedback requesting more discussion on the topic at future Summits.

  • Driving Innovation: Blockchain Adoption For Clinical Trials Optimization
    Driving Innovation: Blockchain Adoption For Clinical Trials Optimization

    Pharmaceutical companies and research institutions are feeling the pressure to reduce the time, financial, and other resource costs associated with conducting clinical trials. With the influx of emerging applications for technologies such as machine learning, robotics and automation, and blockchain and other distributed ledger technologies (DLTs), many see a new path to more efficient and effective processes that can address the challenges faced today.

  • The EU Qualified Person (QP) Demystified: Fool-Proofing Your EU Phase 1 Trial
    The EU Qualified Person (QP) Demystified: Fool-Proofing Your EU Phase 1 Trial

    For U.S. sponsors planning to conduct clinical trials in the EU, Qualified Persons (QPs) may at times be perceived as a challenge to overcome, because their role and responsibilities are not fully understood. Conversely, part of the QP’s role is to support clinical trials in the EU by certifying compliant clinical trial materials while protecting public health.

  • Preparing For Health Authority Inspections: 4 Keys To Inspection Readiness
    Preparing For Health Authority Inspections: 4 Keys To Inspection Readiness

    Health authority inspections are one of the most stress-inducing experiences a sponsor, CRO, or site will go through. The mere mention of inspections is enough to throw some people into full on panic-mode. While preparing for an inspection will never be a care- and stress-free process, there are appropriate ways to get your organization ready for one without adding another layer of stress and frustration.

  • 5 Narrative Elements That Will Reveal The Masterpiece In Your TMF
    5 Narrative Elements That Will Reveal The Masterpiece In Your TMF

    In response to the increasing opacity of the trial master file (TMF), clinical trial decision makers have embraced quantitative metrics as a way of characterizing and understanding the health of a TMF. Quantitative metrics are easily generated through the reporting functionality of a modern electronic TMF (eTMF) and appear to add value by leveraging the data passively generated through modern clinical applications. Although helpful to address specific concerns, especially those related to completeness, these metrics are often unintuitive and do not readily describe the aspects of a clinical trial most instrumental for TMF health.

More From Our Guest Columnists

CLINICAL TRIAL WHITE PAPERS

  • CAR-T Cell Therapies: Safety Considerations and Toxicity Management

    Along with demonstrated efficacy in hematologic malignancies, CAR-T cells have the capacity to elicit serious toxicities. Safety considerations related to CAR-T cells may impact both trial design and trial management, as the adverse events (AEs) associated with immuno-oncology agents differ from those associated with cytotoxic therapies. Learn how to make anticipating, preventing and managing toxicity a key component of clinical studies involving CAR-T cells.

  • Advanced Analytics For The Monitoring Of Clinical Trials

    Clinical research generates a massive amount of data. Unfortunately, because of the way most clinical data programs currently work, much of these data are not used to their fullest extent; they are simply filed away. This white paper will focus on the benefits provided by a unique and advanced analytical approach to study monitoring beyond the minimum necessary RBM approach.

  • Bringing Real World Evidence Into Clinical Research

    Life sciences companies are embracing the essential roles that real world data (RWD) and the generation of real world evidence (RWE) play in the development of new treatments for patients.This paper will explore three areas where RWD and RWE are being applied to improve the design and execution of clinical studies.

  • 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.

  • Differentiating Oncology Research Pipeline In Today’s Competitive Era

    With novel therapies being launched there is a shift in data and evidence requirements as well. How can you be sure you are keeping up with the real-world evidence demands?

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • Trends In Oncology Trial Terminations Due To Toxicity

    Are studies focusing on elderly cancer patients at increased risk for discontinuation due to safety reasons, such as toxicity?

  • AstraZeneca Takes An Innovative Approach To Trial Results Summaries

    AstraZeneca made a commitment in 2015 to deliver PLS in advance of the European Medicines Agency (EMA) policy coming into play, says Julie Holtzople, Clinical Trial Transparency Operations Director. Many other sponsors have followed suit, taking a proactive approach to clinical trial disclosure and transparency. The statistics explain why. According to a 2017 (CISCRP) study1, 72% of the respondents said they want a summary of their results, 91% thought receiving results was really important, and 53% said they had never received a summary of results. “Our leadership made that commitment, and then we had to go figure out how to do it,” Holtzople says.

  • Conquer Study Start-Up Delays With A Data-Driven Approach

    Study start-up delays have perplexed the best minds in the clinical trials industry for decades. Discover how advanced analytics and an intense focus on the four problem areas can help.

  • Business And Cultural Considerations When Managing Clinical Supplies For Asia-Pacific Studies

    In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.

  • Comparing Continuous And Batch Processing In Downstream Purification

    Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.

  • eSource Is Here: What To Do Today To Ensure Success Tomorrow

    What can organizations – both in research and in technology – do to help define that future?

More Clinical Trial App Notes & Case Studies

CLINICAL LEADER CONTENT COLLECTIONS

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Patient recruitment and retention continue to hamper clinical trials, causing delays in start up and forcing some studies to be cancelled altogether. Approximately 50 percent of trials have delays in recruitment, costing companies an estimated $600,000 per day. In this free collection of articles, our experts from pharma discuss the actions you can and should be taking to make trials more patient centric.

More Content Collections

FOCUS ON PATIENTS

  • Hybrid Decentralized Trials: Using Technology To Create More Patient-Centric Studies
    Hybrid Decentralized Trials: Using Technology To Create More Patient-Centric Studies

    While it is not a new trend, the spotlight on digital innovation has grown brighter over the last year, with executives from all sides of the clinical research industry seeking technology solutions to improve the clinical trial experience for sites and patients alike. It was a recurring theme at this year’s Society for Clinical Research Sites (SCRS) Global Site Solutions Summit, with several sessions that addressed technological advancement and attendee feedback requesting more discussion on the topic at future Summits.

  • Collaborating With Patients: 3 Key Considerations For Drug Sponsors
    Collaborating With Patients: 3 Key Considerations For Drug Sponsors

    Historically, patient involvement has been vital in the design and execution of clinical trials, but in recent years there has been an increased desire to engage patients from start to finish during the drug development process. Today, patients are empowered by technological advances that have given them access to more information than ever before, especially regarding diseases and drug development.

  • The Patient Perspective On Patient Centricity: Insights From A Veteran Of 5 Clinical Trials
    The Patient Perspective On Patient Centricity: Insights From A Veteran Of 5 Clinical Trials

    Those who know me understand the value I put on bringing the voice of the patient and caregiver into the drug development process. They also know that I believe that today’s terminology — phrases like “patient-centricity,” “patient at the center,” and other sexy mottos — is sometimes used by organizations to show the world that the patient is at the forefront of everything they do. But are they really? Is patient feedback on a protocol enough to prove that their voices are heard? Is providing input on an informed consent what a patient really wants to do? Maybe.

More From Our Focus on Patients Series

LIFE SCIENCE INDUSTRY EVENTS

Evolution Summit November 18 - 20, 2019
Boston, MA
Preparing eCTD Submissions: A Step-By-Step Guide November 19 - 19, 2019
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance November 20 - 20, 2019
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Establishing Appropriate Quality Metrics November 21 - 21, 2019
1pm-2:30pm EST, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control December 12 - 12, 2019
1pm-2:30pm EST, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
More Industry Events