GUEST COLUMNISTS

  • 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.

  • 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.

  • What Will Clinical Trials Look Like In 10 Years? Experts Forecast 3 Key Trends
    What Will Clinical Trials Look Like In 10 Years? Experts Forecast 3 Key Trends

    Clinical research has benefited from several advancements in recent decades. Expanding access to information has empowered patients to have greater autonomy in their care and a voice during the development process. Personalized medicine has given rise to promising new therapies treating smaller, more targeted populations. And the number of clinical trials leveraging virtual health tools and mobile technology is increasing. But seismic challenges still remain.

  • 8 Steps To Achieve The Cultural Change Needed For Co-Creation With Patients
    8 Steps To Achieve The Cultural Change Needed For Co-Creation With Patients

    Now more than ever, patients are informed and active about their health. Technological advances are equipping patients with real-time health data. At-home genetic testing kits have the potential to reveal future health risks. And the internet can help increase health literacy and connect patients with other patients. These, and other tools, can empower patients to take control of their health while enhancing their ability to engage with the healthcare ecosystem.

  • RWE In Clinical Research: Challenges, Opportunities, And 2 Case Studies To Move Us Forward
    RWE In Clinical Research: Challenges, Opportunities, And 2 Case Studies To Move Us Forward

    This is the second article in a two-part series addressing real-world evidence (RWE) for life sciences leaders who may be struggling to make sense of the rules. In this part, we will explore the challenges and opportunities RWE presents for life sciences companies, review two recent examples, and discuss how this newer way of thinking will transform the way we design and conduct clinical research or evaluate value-based decisions for the better.

  • Tackling Pharmacovigilance Issues In The Clinical Trial Stage Of Product Development
    Tackling Pharmacovigilance Issues In The Clinical Trial Stage Of Product Development

    Pharmaceutical and device manufacturing companies often outsource their pharmacovigilance (PV) activities to vendors and consultants to meet their safety, medical information, and regulatory needs. When doing so, these companies have a regulatory obligation to oversee the activities and quality of their vendors. However, vendor audits conducted by these companies can yield a wide range of results due to differences in auditors, scope, and understanding of PV principles and operations.

More From Our Guest Columnists

CLINICAL TRIAL WHITE PAPERS

  • Pharma’s Digital Awakening: Research-Ready Health Information And AI To Reduce Cost And Deliver Better Treatments

    Digital innovations and their emerging technologies, such as artificial intelligence (AI), advanced analytics, and cloud-based computing, are transforming industries and markets across the world as they offer novel ways to boost R&D, increase product quality and safety, and ultimately improve customer satisfaction.

  • Seven Essentials For Successful Drug Development

    In reflecting on the differences between successful and unsuccessful clinical trials or programs, several factors consistently emerge as essential components of success and failure. This article reminds of the essentials so that effective therapies have a greater likelihood of reaching patients in need.

  • Embracing Innovative Designs In Early Phase Oncology Trials

    Advancements in science and technology are driving accelerated timelines and creative pathways for oncology drug development. Oncology sponsors and regulators seek new ways to efficiently move promising therapies from the clinic to approval – embracing a streamlined path that bypasses the traditional development paradigm of standalone sequential Phase I/II/III trials.

  • Adaptive Trial Design and Implementation

    Understand the concept and benefits of adaptive trials and if they should be a consideration for your company.

  • Objectively Tracking Lesions In Dermatology Clinical Trials

    There is an increasing need for objectivity in mapping and analyzing of lesions to create confidence in trial findings, reproducibility and translation to clinical practice for dermatology sponsors, regulators and clinicians. This paper examines evolving diagnostic practices coupled with advancing technology and their application to reduce subjectivity in dermatology clinical trials.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • Custom Software Enhances Decision-Making

    AstraZeneca needed a software tool that could create standardized outputs to streamline communication, save time, and extend the framework with additional features.

  • How To Accelerate Trial Enrollment: What Works And What Doesn’t

    As you evaluate clinical trial enrollment acceleration strategies, be sure to understand the root causes of slow enrollment and the reasons why traditional acceleration programs do not work. 

  • CRO Consolidations – A Boon for Pharma?

    CRO mergers affect the agility and speed of operations and may hamper efforts to bring in new technologies but at the same time can add significant value to both the pharmaceutical industry and the patients who depend on the life-saving medicines it produces.

  • Innovative Clinical Supply Solutions - Cold Chain

    With our team of packaging experts and extensive cold chain capabilities, this case study discusses the creation of a custom packaging and distribution solution to meet this client’s unique needs. Through our partnership, the product was successfully packaged in sufficient quantity and on time for the Phase I trial.

  • Leveraging Expertise To Exceed Immunotherapy Customer Goals

    A biologics company needed a CRO with a dedicated oncology team to manage its Phase I, multi-center study to evaluate the safety and pharmacokinetic (PK) profile of an immunotherapeutic drug in subjects with advanced solid tumors. They found a clinical trial partner with oncology experience that could support protocol design and accelerate the start-up process to meet a quick first-patient-in (FPI) milestone.

  • Expert Project Management And An Effective Comparator Sourcing Strategy Streamlines Sponsor’s Complex Global Trial

    Some clinical trials face numerous and critical complexities which increase pressure and risk for the success of the trial. This case study, highlights the complexities faced by one sponsor that were compounded by rigid timeframes, comparator sourcing availability, sensitized drug product and intricate kit design. By partnering with Almac, the sponsor was able to harness Almac’s expertise in project management and comparator sourcing to deliver multiple shipments to sites and depots on time and within specified conditions.

More Clinical Trial App Notes & Case Studies

CLINICAL LEADER CONTENT COLLECTIONS

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Learn how to find and hire competent CRAs in this free collection of articles highlighting CRA turnover as well as how to spot fraudulent resumes and counterfeit degrees. 

More Content Collections

FOCUS ON PATIENTS

  • 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.

  • 8 Steps To Achieve The Cultural Change Needed For Co-Creation With Patients
    8 Steps To Achieve The Cultural Change Needed For Co-Creation With Patients

    Now more than ever, patients are informed and active about their health. Technological advances are equipping patients with real-time health data. At-home genetic testing kits have the potential to reveal future health risks. And the internet can help increase health literacy and connect patients with other patients. These, and other tools, can empower patients to take control of their health while enhancing their ability to engage with the healthcare ecosystem.

  • An Inside Look At Novo Nordisk’s Disease Experience Expert Panel (DEEP) Model
    An Inside Look At Novo Nordisk’s Disease Experience Expert Panel (DEEP) Model

    Novo Nordisk recognized that if it wanted to develop innovative treatments for patients living with chronic diseases, it was essential to form meaningful partnerships in which patients’ expertise, knowledge, and experience are included and put into action. It was this radical shift in thinking that led to the creation of the Novo Nordisk Disease Experience Expert Panel (DEEP), a network of patient experts and advocates.

More From Our Focus on Patients Series

LIFE SCIENCE INDUSTRY EVENTS

Writing Effective 483 and Warning Letter Responses October 23 - 23, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
CNS Summit October 31, 2019 - November 3, 2019
Boca Raton, FL
Cleanroom Microbiology – A Foundational Introduction November 5 - 5, 2019
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Implementing a Robust Change Control Program – Key Elements for Process and Documentation Compliance November 6 - 6, 2019
1pm-2:30pm EST, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It Works November 12 - 12, 2019
1pm-2:30pm EST, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
More Industry Events