GUEST CONTRIBUTORS

  • An FDA Perspective On Patient Diversity In Clinical Trials
    An FDA Perspective On Patient Diversity In Clinical Trials

    Since the late nineteenth century, it has been well-known that individuals can vary widely in their responses to the same medication. Yet, accurately predicting and addressing the effects of that variability during drug development has continued to bedevil researchers, drug sponsors, and regulators.

  • 4 Villains That Can Delay Your Clinical Trial Agreement (CTA) And How To Defeat Them
    4 Villains That Can Delay Your Clinical Trial Agreement (CTA) And How To Defeat Them

    Imagine for a moment you are your favorite superhero, charged with the task of saving the whole world from villains such as the Joker, Lex Luthor, Doctor Doom, and the Green Goblin. You would not be very effective — or much of a superhero, for that matter — if you only took one of them out while letting the others roam free. In the same way, as an industry, we cannot effectively tackle the issue of delays in the execution of Clinical Trial Agreements (CTAs) by only addressing one or two of the “villains” contributing to this industrywide problem. 

  • Can Mexico Become A Regional Powerhouse For Clinical Trials?
    Can Mexico Become A Regional Powerhouse For Clinical Trials?

    Located between the United States and Central America, Mexico’s geography and Spanish language put it in an ideal position to act as a gateway to Latin American pharmaceutical markets. With an estimated size of $10 billion in 2016, the country’s pharmaceutical market ranked twelfth globally, lagging behind only Brazil as the second biggest market in Latin America. Mexico has a stable economy, and although it is classified as upper-middle income, it also offers lower costs than other countries.

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CLINICAL TRIAL WHITE PAPERS

  • Managing eCOA Data: Principles & Best Practices For Data Managers
    Managing eCOA Data: Principles & Best Practices For Data Managers

    With the quality of data captured throughout a trial playing a crucial role for the success or failure of a study, clinical data management (CDM) is a key element of any research program. During a study lifecycle, data managers will deal with data from many sources such as MRI scans, ECG, lab data, as well as eCOA – all of which are equally important. 

  • Mobile Apps: A 360° Guide For Clinical Trials
    Mobile Apps: A 360° Guide For Clinical Trials

    This paper isolates three specific areas that warrant close attention for app developers, clinical trials sponsors and CROs designing trials powered with mHealth app tools: technology considerations, data considerations and regulatory considerations. These areas are vital to developing a compliant trial that generates meaningful data for clinical development using mHealth sources.

  • Applying An Innovative Mindset To Post-Approval Research
    Applying An Innovative Mindset To Post-Approval Research

    Post-approval research studies are becoming increasingly large and complex in the clinical research landscape. These programs are often massive in scope, engaging thousands of physicians and tens of thousands of patients. Unfortunately, post-approval operational strategies have not kept pace with the needs and demands of post-approval (Phase IV) research.

  • Reducing The Burden Of Data Collection In Oncology Trials
    Reducing The Burden Of Data Collection In Oncology Trials

    Understanding patient reported outcomes (PROs) in oncology clinical trials enables researchers to develop more effective treatments for patients battling this illness. But if it isn't easy for patients to report their health data, they won't - so it must be accessible for them.

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ABOUT CLINICAL LEADER

Welcome to Clinical Leader, the premier online community that helps streamline clinical research by connecting trial sponsors and cutting edge service providers. Clinical Leader is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

Visitors are enriched with valuable information on CRO, Pre-Clinical Contract Research Organization, Bio-Analytical Contract Research Organization, Clinical Contract Research Organization, Pharmacovigilance, Clinical Data Management, Electronic Patient Reported Outcomes (ePRO), Point-of-Care Testing (POCT), Patient Recruitment, Electronic Data Capture (EDC), Clinical Trials Management Systems (CTMS) and more that can improve your business and make it more profitable.

Please take a moment to join our community and discover the benefits of your free membership.

INDUSTRY INSIGHTS

  • 3 Ways To Avoid The Hidden Costs Of EDC Training And Support
    3 Ways To Avoid The Hidden Costs Of EDC Training And Support

    It has now been several decades since EDC was first introduced as a tool for data management in clinical trials. In that time, boosted by continuous developments and enhancements, the technology has grown from a somewhat esoteric alternative to paper to a standard considered essential throughout most of the industry. Without thorough and comprehensive training and support resources, though, it will be a challenge for today’s EDC users to fully benefit from the capabilities the technology has developed over the years. While the best EDC systems are defined by simplicity and intuitiveness, they still offer an intricate array of functionalities that require a certain level of instruction in order to access.

  • What Does The Chan Zuckerberg Biohub Mean For Clinical Research And EDC?
    What Does The Chan Zuckerberg Biohub Mean For Clinical Research And EDC?

    Medical research has seen a great deal of high-profile philanthropic investment in recent years. Last year, for example, tech billionaire Sean Parker made a $250 million donation to further the development of immunotherapy. More recently, the Chan Zuckerberg Biohub has made headlines by announcing plans to invest $3 billion in new research over the next 10 years. The investment is part of the Biohub’s ambitious goal of curing all disease by the end of the century. It will be directed toward a wide array of medical solutions including new drugs, vaccines, and diagnostic tests - and the first round of grant recipients has already been chosen.

  • The Vanguard of Patient Centricity: Patient-Led Clinical Trials
    The Vanguard of Patient Centricity: Patient-Led Clinical Trials

    Amid the AIDS epidemic during the late 80’s, Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, found himself at a crossroads. As a long-time proponent of the traditional “research to approval” drug development model, involving randomized clinical trials and lengthy regulatory reviews, Fauci was faced with the realization that this traditional approach would be of little benefit to AIDS patients without the luxury of time. Something had to be done. But what?

  • EMA Guidance On Risk Management Plans (RMPs) In The EU
    EMA Guidance On Risk Management Plans (RMPs) In The EU

    On Friday, 31 March 2017 the EMA released the revised Module V- Risk Management Systems (Rev 2) of Good Pharmacovigilance Practice (GVP) (EMA/838713/2011 Rev 2) accompanied by a revised Guidance on the format of the risk management plan (RMP) in the EU – in integrated format (EMA/PRAC/613102/2015 Rev.2).

  • The Pulse On Clinical Study Startup
    The Pulse On Clinical Study Startup

    Clinical project managers are expected to make smarter decisions on intelligence derived from clinical trial data and sponsors/CROs are looking for ways to incorporate Business Intelligence into the eClinical systems they are using to empower oversight — turning raw trial data into actionable information.

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LIFE SCIENCE INDUSTRY EVENTS

Best Practices in CMC Dossier Preparation – Facing Tough Challenges April 24, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Document Authoring, Archive, and Inspection – Challenges And Tips For Establishing Audit-Proof Processes April 25, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Cleaning Validation – Health Based Limits and Beyond: Answers to Current Industry Gaps April 26, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Computer Systems Validation (CSV) – Avoiding The Top Five Regulatory Pitfalls May 2, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
eSource Data in Clinical Investigations Bootcamp May 2 - 3, 2017
Philadelphia, PA
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