GUEST CONTRIBUTORS

  • Accelerating Clinical Trial Patient Engagement & Retention Through Mobile Technology
    Accelerating Clinical Trial Patient Engagement & Retention Through Mobile Technology

    This article assesses the mobile health apps market, key features of successful apps, and associated timelines and costs for developing apps that engage patients across categories and conditions.

  • How To Ace Your FDA IND Submission (And How To Rebound If You Don’t)
    How To Ace Your FDA IND Submission (And How To Rebound If You Don’t)

    Whether you read Part 1 of this three-part series — and sought pre-IND (Investigational New Drug) feedback from the FDA — or not, let's assume you have your pre-IND ducks in a row. Now you're ready to embark on preparing and submitting the IND application to the FDA, which, if approved, will allow you to test your drug in humans for the first time.

  • The 4 Biggest Investigator Site Payment Issues — And How To Solve Them
    The 4 Biggest Investigator Site Payment Issues — And How To Solve Them

    Imagine that after a tedious job interview process you are finally offered what promises to be a fulfilling and rewarding position with a new company. However, after working there for a while, you notice that the employer is only really paying you every three to six months, which has made it difficult to keep up with your bills and to stay financially afloat. You also notice that when you do receive a check from the employer, you have no way of verifying for which days or hours you have been paid since no explanation is sent with the check and you were never told who at the company you could contact for these types of questions.

  • Evidence Synthesis: Reducing The Guesswork Of Clinical Trial Design

    One of the biggest challenges to the success of new drugs is that approval and uptake rely heavily on the evidence collected during development, yet decisions on the design of clinical trials occur long before much is known about a drug or its effects. The available evidence for existing and potential competing interventions is expanding constantly, raising the stakes for efficient and appropriate study design even further.

  • Open Source Data: Fact Or Fiction

    At the recent Data & Technology in Clinical Trials conference, I had the pleasure of listening to Aneesh Chopra speak. Chopra is the president of NavHealth and formerly served as assistant to President Barack Obama and Chief Technology Officer of the United States. His speech was electrifying, dynamic, and set the room abuzz.

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CLINICAL TRIAL WHITE PAPERS

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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

  • 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.

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LIFE SCIENCE INDUSTRY EVENTS

Root Cause Analysis Post ICH GCP E6 (R2): Beyond Fishbones and 5 Whys! March 27, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD) – An Overview March 28, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Clinical Trial Collaborations April 3 - 4, 2017
Renaissance Boston Waterfront Hotel, Boston, MA
Electronic Informed Consent (eIC): How The New FDA/OHRP Final Guidance Affects You April 4, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Drug Development 101 – How A Drug Is Made April 5, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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