GUEST CONTRIBUTORS

  • Improving Patient Retention & Engagement Through Health Programs
    Improving Patient Retention & Engagement Through Health Programs

    Patient recruitment is often highlighted as the key factor in ensuring clinical study success. Ensuring on-time enrolments of patients, investigators, etc. is a constant concern throughout the clinical trial phases. However, patient retention through engagement is also a key factor — and one that is often overlooked. Patient dropout rates for pharmaceutical clinical trials are estimated to range between 15 to 40 percent of enrolled participants, depending on the trial phase.

  • 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

    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.

More From Guest Contributors

CLINICAL TRIAL WHITE PAPERS

  • 5 Ways MasterControl Ensures System Compliance With 21 CFR Part 11

    Under 21 CFR Part 11, FDA-regulated companies that choose to maintain electronic records to meet predicate rules are required to validate their electronic record-keeping systems.

  • User Testing ... Time Is Running Out It is now over two years since Directive 2004/27/EC introduced a change in the order of presentation of information in patient information leaflets (PILs) and the requirement that PILs should reflect the results of consultations with target patient groups. We have until July 2008 to comply with Article 59(3) and to complete user tests for all existing, as well as new products. Submitted by ICON
More Clinical Trial White Papers

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

  • Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies
    Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies

    There are many reasons to be excited by the science being presented at this year’s American Society for Clinical Oncology meeting. The data presented at a special section on Saturday morning opened the door to a future when tumor genetics and biomarkers will change the way we think of about cancer treatment. As a physician working in clinical development, there is also the excitement around intriguing new questions that when answered could lead to life-saving treatments unimaginable just a decade ago. 

    More than 2,000 people packed into a cavernous conference hall at 8 a.m. on Saturday – demonstrating the high level of shared interest in emerging immunotherapies.  

  • Key Considerations For Companies Outsourcing Their Clinical Packaging Needs
    Key Considerations For Companies Outsourcing Their Clinical Packaging Needs

    From virtual biotech companies to large pharmaceutical companies, outsourcing is a key consideration in clinical packaging and distribution. According to Sherpa Clinical Packaging, although outsourcing is a valuable strategy for companies of all sizes and capabilities, it should be entered into for reasons specific to a company’s requirements.

  • Start Using Your CTMS In A Fraction Of The Time With Significant Cost Savings
    Start Using Your CTMS In A Fraction Of The Time With Significant Cost Savings

    With thousands of people, hundreds of investigative sites, multiple CROs and various eClinical source systems—all generating massive amounts of data—clinical trials are an enormous undertaking. While leading organizations use Clinical Trial Management Systems (CTMS) to centralize operational data and automate processes so they can make better decisions, a CTMS can be out of reach for many small to mid-size companies, leaving them with isolated spreadsheets and/or inefficient, manual practices.

  • Reducing Study Rescue: The Importance Of Getting Clinical Trials Off To A Good Start
    Reducing Study Rescue: The Importance Of Getting Clinical Trials Off To A Good Start

    Clinical trials are not for the faint of heart. Conducting even one clinical trial is a monumental task with complex processes and issues that can surface and derail a study’s timeline. As a result, delays in regulatory filing, market entry, and ultimately, the delivery of new therapies to patients are all too common.

  • Top 3 Benefits Of Electronic Data Capture Adoption - Infographic
    Top 3 Benefits Of Electronic Data Capture Adoption - Infographic

    Electronic Data Capture (EDC), which collects clinical trial data electronically rather than on paper, is becoming an increasingly popular solution for streamlining data processing.

More Industry Insights

LIFE SCIENCE INDUSTRY EVENTS

Clinical Data Disclosure and Transparency January 18 - 19, 2017
Philadelphia, PA
Remote Monitoring Implementation Post ICH GCP E6 (R2): A Practical Guide January 18, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Using the ACE Program for FDA Imports – Ensuring Compliance & Speedy Product Delivery January 20, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
The Investigational New Drug (IND) Submission - Tips to Win the First Time January 25, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Data Integrity - Detecting & Mitigating Risk January 26, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
More Industry Events

TRAINING COURSES

Remote Monitoring Implementation Post ICH GCP E6 (R2): A Practical Guide January 18, 2017
1pm-2:30pm EST, Online Training
The Investigational New Drug (IND) Submission - Tips to Win the First Time January 25, 2017
1pm-2:30pm EST, Online Training
Data Integrity - Detecting & Mitigating Risk January 26, 2017
1pm-2:30pm EST, Online Training
More Upcoming Courses