GUEST COLUMNISTS

  • How To Conduct Better GCP Audits (Even When You Feel Like An Impostor)
    How To Conduct Better GCP Audits (Even When You Feel Like An Impostor)

    How many of us drive to work every day? How many of us know the route so instinctively that we no longer think about where we have to go? It’s easy, right?

  • How Many Internal ClinOps Resources Should You Have For Study Startup?
    How Many Internal ClinOps Resources Should You Have For Study Startup?

    If you are like most small biotech companies, your budget is small and your timelines are as tight as possible in order to get the data needed to support the next round of funding and take the next step in your clinical development program. The best insurance you can use to achieve that next step and end up with a high-quality study that will pass an audit or inspection is proper planning ahead. This article will focus on proper resourcing of a sponsor’s internal clinical operations (ClinOps) team to adequately support a clinical trial during study startup.

  • 5 Tactics To Overcome Technology & Innovation Adoption Challenges In Clinical Research
    5 Tactics To Overcome Technology & Innovation Adoption Challenges In Clinical Research

    Our global digital population — people around the world that are active internet users — has grown to 4.3 billion as of July 2019, representing roughly 56 percent of the global population. Of this global digital population, almost 4 billion are accessing the internet using mobile devices, with non-tablet mobile devices contributing nearly half of web page views worldwide.

  • Email/Excel vs. Clinical Applications: What Do ClinOps Professionals Really Need?
    Email/Excel vs. Clinical Applications: What Do ClinOps Professionals Really Need?

    The Veeva 2019 Unified Clinical Operations Survey examines the extent to which the clinical trial industry has sought to overcome its dependence on outmoded processes through the implementation of clinical applications. The survey’s main objective is to grow understanding of the “drivers, barriers, and benefits of a unified clinical operating model” through the exploration of clinical stakeholders’ attitudes about the clinical applications they currently use.

  • 3 Critical Areas To Review In Strategic Site Selection
    3 Critical Areas To Review In Strategic Site Selection

    Have you ever put off doing something you knew needed to be done, even though you had the ability and money for it?  Think exercising, getting a will or going to the dentist (hopefully you have dealt with at least the latter).  In the same way, many study sponsors put off aggregating and utilizing key intelligence on their previously used investigator sites for use in future strategic site selections. At times, there will be unique reasons for engaging with a certain investigator site or the need to use research-naive sites. However, if previously used sites will be considered for a new study, it is vital to review some key information for a truly strategic site selection process.  Let's take a look at some of these key, yet often forgotten, areas.

  • Standard Of Care And The Internet Of Medical Things
    Standard Of Care And The Internet Of Medical Things

    During the American College of Cardiology annual meeting in March, researchers from Stanford University, Apple Inc., and other academic centers unveiled the Apple Heart Study, a first-of-its-kind large-scale study involving more than 400,000 members of the general population (iPhone and Apple Watch owners). The goal of the study was to identify users with a potentially lethal irregular heart rhythm called atrial fibrillation (AF).

  • Merck’s Patient-Centric Approach To Trial Recruitment, Representation, And Retention
    Merck’s Patient-Centric Approach To Trial Recruitment, Representation, And Retention

    Patient behaviors have changed drastically in recent years. With the widespread adoption of digital technologies, such as wearable devices that transmit patient data, and a surge in health-related information available online, patients have become more knowledgeable and engaged in the management of their own health than ever before.

  • Developing Triple-Combination Immunotherapies: Lessons Learned From HIV
    Developing Triple-Combination Immunotherapies: Lessons Learned From HIV

    Our body’s immune system appears to be the most effective therapy to fight cancer—more so than chemotherapy, radiotherapy, or any other anti-cancer therapy currently available. However, the immune system is only effective if it can detect cancer cells.

More From Our Guest Columnists

CLINICAL TRIAL WHITE PAPERS

  • 505 (b)(2) vs. ANDA: How Complex Drugs Fit In
    505 (b)(2) vs. ANDA: How Complex Drugs Fit In

    Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.

  • Top Five Reasons You Need IRT Expertise (Not Just Software)

    How IRT vendor relationships can ensure high quality builds that meet pharma companies' needs and avoid the potential pitfalls associated with RTSM.

  • How Virtual Trials Support Patient-Centricity

    In this digital age, virtual trials may very well become the norm at some point in the future, but there are many questions to answer before this can become a reality. In this white paper, we propose how virtual trials may be able to solve all these issues at once while also providing the added benefit of reducing costs related to study sites.

  • Health Consumer Mindsets

    How are consumers engaging with their healthcare in today’s environment and what drives engagement, and what hinders motivation or ability to engage? This study explores these questions.

  • Clinical Trial Disclosure Management: Build vs. Buy

    The big challenge for study sponsors is that clinical trial transparency remains a “volatile” area with continuously evolving requirements and expectations. Most life sciences companies don’t have the time, money or resources to develop a compliance solution.

  • An Overview Of The ICH E6 (R2) Guideline

    While the revisions to the guideline mainly impact sponsors, technology providers and contract research organizations need to be aware of the changes and make adjustments to operational procedures, documentation practices, quality approaches and computerized system functionality.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

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. 

FOCUS ON PATIENTS

  • Merck’s Patient-Centric Approach To Trial Recruitment, Representation, And Retention
    Merck’s Patient-Centric Approach To Trial Recruitment, Representation, And Retention

    Patient behaviors have changed drastically in recent years. With the widespread adoption of digital technologies, such as wearable devices that transmit patient data, and a surge in health-related information available online, patients have become more knowledgeable and engaged in the management of their own health than ever before.

  • Trial Navigators: The Key To Increased Patient Participation In Clinical Trials
    Trial Navigators: The Key To Increased Patient Participation In Clinical Trials

    The appallingly low rates of patient participation in cancer clinical trials, especially in the community setting, is no secret. The fact is that 98 percent% of our patient population isn’t aware of available trials, doesn’t know how to apply, or is under too much financial and emotional strain, etc. to even consider joining a trial. The blame for this rightfully falls on the proverbial shoulders of the main stakeholders: the biopharmaceutical industry, healthcare institutions, government, and — yes — patient support groups. 

  • Clinical Trials In The Era Of Precision Medicine: What Needs To Change?
    Clinical Trials In The Era Of Precision Medicine: What Needs To Change?

    Part 1 of this two-part article examined the implications the transition to value-based, patient-centric, precision medicine has for drug discovery, development, and deployment, particularly for clinical trials. Part 2 explores precision medicine in more depth regarding the tailored and targeted treatments that aim to match patients to medicines according to particular clinical, demographic, and lifestyle factors.

More From Our Focus on Patients Series

LIFE SCIENCE INDUSTRY EVENTS

Lyophilization - An Introduction to the Scientific Principles August 27 - 27, 2019
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success September 4 - 4, 2019
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
The Top Method Validation Mistakes – And How to Avoid Them September 9 - 9, 2019
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Pediatric Clinical Trials: Special Considerations and Requirements September 13 - 13, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
More Industry Events