GUEST CONTRIBUTORS

  • Trump And The FDA: What to Expect (And What’s At Stake)
    Trump And The FDA: What to Expect (And What’s At Stake)

    Donald Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn about the agency, to help facilitate the transition from the Obama administration to the Trump administration. In this article, I describe what I expect the nascent 2017 agenda will be as Trump’s team walks in the door, and I offer a few thoughts as to why the Trump team would do well to consider the unique nature of FDA as transition planning takes shape.

  • A Relationship Driven By Technology:  How Sponsors And CROs Can Improve Collaboration
    A Relationship Driven By Technology: How Sponsors And CROs Can Improve Collaboration

    The typical relationship between clinical trial sponsors and CROs is rarely described as ‘simple.’ And few, if any, are based on the trust and collaboration that would improve efficiencies in clinical research. With over 70% of clinical trials being outsourced to CROs, and less than 10% meeting trial completion dates, the question becomes not when, but how can this critical relationship be improved to make clinical development more efficient?

  • Three Questions To Ask When Evaluating a Patient Recruitment Plan
    Three Questions To Ask When Evaluating a Patient Recruitment Plan

    Today is a big day. Today is the day your clinical protocol is finalized. Your inclusion and exclusion criteria are polished to perfection. Your informed consent form has “IRB APPROVED” stamped on it in big, bold letters. Now is the time to deliver it into the eager hands of eligible patients.

  • The High Price Of Failed Clinical Trials: Time To Rethink The Model

    Back in 2014, a study in Nature Biotech showed that only 32% of drugs have a probability of making it to Phase 3 trials, and only one in 10 drugs overall actually makes it to market. Things haven’t improved since then. BIO recently put out a study reporting that the average overall likelihood of approval (LOA) by FDA from Phase I was 9.6 percent – a 1 in 10 chance. The rate is even lower for major disease areas like oncology.

  • CROs Can Be Indispensable As Pharma Companies Focus On Value

    The healthcare industry’s transition to value-based care is putting a lot of pressure on pharmaceutical companies in terms of margins and the need to demonstrate improved outcomes at lower costs. In attempting to create breakthrough therapies and “beyond the pill” solutions with fewer resources, companies are demonstrating an increased appetite for outsourcing functions – and Contract Research Organizations (CROs) could be the beneficiaries.

More From Guest Contributors

CLINICAL TRIAL WHITE PAPERS

  • Why Choosing The Right Digital Collaboration Program Is Critical To Future Success

    Increasing drug development costs, longer trial durations and insufficient rates of success are prompting the search for innovative solutions for clinical trials. As sponsors seek new ways to mitigate risks and maximize opportunities in clinical development efficiencies, many are turning to a digital collaboration platform. By Within3

  • How ePRO Improves Trial Efficiencies

    Sponsors, trial managers and health outcome directors continue to obtain greater degrees of data quality, program efficiency and patient safety with ePRO. Studies show that in a typical clinical trial involving 250-300 patients over 3 months, using ePRO rather than paper to capture patient data can save as much as $150,000. At the same time, ePRO improves the trial’s efficiency and trustworthiness, yields better quality data, reduces trial length, and makes it more likely new drugs will receive agency approval.

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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

  • Smooth IRT (IVR/IWR) Vendor Transition Guide
    Smooth IRT (IVR/IWR) Vendor Transition Guide

    Pharmaceutical and biotech companies are increasingly reliant on their CROs (contract research organizations) and vendor partners to provide innovative, cutting edge solutions that will help them bring new therapies to market faster. According to a recent market research report1, the global clinical development outsourcing market will reach more than $64 billion by 2020, with CROs managing close to 72% of all clinical trials. As sponsors continue to adopt the outsourced model, sponsor-vendor relationships will play a pivotal role in the success of the clinical trial.

  • Phase I In The Age Of Precision Medicine And Patient Diversity
    Phase I In The Age Of Precision Medicine And Patient Diversity

    As clinical research evolves and becomes more refined, the industry is coming to acknowledge a simple truth: that everyone is different. A drug that works wonders for one individual may have little to no effect on, or even be detrimental to, another. Alternatively, the discovery that a treatment is ineffective or dangerous in a small group of clinical trial patients may cause the discontinuation of that drug’s development, allowing its potential to help the general population to go undiscovered.

  • CSS Archiving Project With Billions Of Clinical Trial Data Pieces - Infographic

    The CSS Archiving Project s a massive undertaking, containing thousands of trials and billions of trial data pieces from 14 locations all over the world.  With this project in place, World Courier will be able to take client's trial records and either return them, destroy them or archive them in a long-term storage.

  • 12 Ways An EDC System Totally Changed My Life
    12 Ways An EDC System Totally Changed My Life

    My career started in clinical research. I was formerly a Study Manager and a Data Manager for a large medical device company. In the early days, we used carbon-based CRFs. We’d manage discrepancies by communicating through fax. Randomizations would be through a batch of envelopes sent to the sites. Inevitably, they’d open the wrong envelope, get the wrong randomization assignment, and you’d scramble to correct things. It was a mess, but that’s how things were run back in the day.

  • You’ve Gone This Far, Now Complete Your TMF
    You’ve Gone This Far, Now Complete Your TMF

    The Medicines & Healthcare Products Regulatory Agency (MHRA), an executive agency of the UK’s Department of Health, recently updated its definition of critical GCP inspection findings to include incomplete and inaccessible trial master files (TMFs). Specifically, the MHRA says the TMF is not compliant if it “…is not readily available or accessible, or the TMF is incomplete to such an extent that it cannot form the basis of inspection....”[1]

    Repeated inspection delays due to inaccessible and incomplete sponsor TMFs prompted the MHRA’s update – in fact, last year, 35% of commercial sponsor inspections required extra days due to an incomplete TMF or lack of accessibility.[2] Now, adding fuel to the TMF fire, nearly 30% of inspectors in the U.K. are refusing to use paper, requiring access to an electronic TMF (eTMF) instead, according to the Drug Information Association’s 2014 TMF survey.[3]

     
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LIFE SCIENCE INDUSTRY EVENTS

The New Medical Device Single Audit Program (MDSAP) for Manufacturers – Analyzing Rewards and Challenges December 8, 2016
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Update to ICH GCP E6 (R2) – Final Changes and Implementation December 12, 2016
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
eCOA/ePRO 2016 December 13 - 14, 2016
Philadelphia, PA
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response December 13, 2016
10:30am-12pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
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