GUEST CONTRIBUTORS

  • CROs Can Be Indispensable As Pharma Companies Focus On Value
    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.

  • Israel’s Emergence As A Go-To Market For Conducting Clinical Trials
    Israel’s Emergence As A Go-To Market For Conducting Clinical Trials

    Driven by the steep costs of hosting clinical trials in the United States and Western Europe, pharmaceutical companies have increasingly turned to global markets to conduct trials over the last decade. During that timeframe, Israel has emerged as an attractive market – bolstered by its high-quality medical infrastructure and well-trained physician workforce, diverse patient population and widespread adherence to Good Clinical Practice (GCP) standards.

  • Phase I Clinical Supply Landscape: Trends, Demarcation And Security
    Phase I Clinical Supply Landscape: Trends, Demarcation And Security

    The core addressable early phase market is USD 11.9 billion growing with a CAGR of 2 – 3 percent. Early-phase trials are outsourced at greater than 60 percent by pharma, as the trials are costly and small in number. The supply market for early phase is comprised by CROs, research centers, and academic institutes. The market size that is comprised by the CROs is estimated to be around USD 8 billion, which is about 67 percent of the early phase market.

  • Pharma And Physicians – The Key To Successful Clinical Trials

    Traditionally in the pharmaceutical and biotech industry worlds, a pharma company develops a candidate product and then works with a group of doctors to test that product under careful standards and procedures—very much managed by the pharma company. If the product shows therapeutic value and safety, it becomes available to prescribers to administer to patients.

  • Are You Recruiting Nurses For Your Clinical Research?

    In clinical trials involving patients with complex medical diseases such as chronic kidney disease or cancer, nursing skills are especially useful. Nurses are trained on how to interact with, evaluate and appropriately care for, patients. They are familiar with complex medical regimes and are comfortable talking with and educating patients.

More From Guest Contributors

CLINICAL TRIAL WHITE PAPERS

  • A Dynamic Approach To Models In Phase I The primary focus in Phase I clinical trials has traditionally been the assessment of safety, tolerability, and pharmacokinetics. However, there has been increasing interest over the last decade in the application of biomarkers and surrogate endpoints in healthy volunteer studies to provide information on putative efficacy, dose response, and time effects of investigational drugs. Submitted by ICON
  • Often Disguised As Wolves In SaaS Clothing, SaaS Knockoffs Fail To Live Up To Expectations

    While many life sciences system vendors espouse the popular promises of Softwareas-a-Service (SaaS) technology, only a rare few can deliver.

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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.

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INDUSTRY INSIGHTS

  • New Apps For Clinical RBM: Improve Patient Safety And Data Quality
    New Apps For Clinical RBM: Improve Patient Safety And Data Quality

    In advising and providing consulting to many different companies in recent years making a switch to risk-based monitoring (RBM) it's become apparent to me that the opportunity to improve patient safety and enhance data quality is the top reason for adoption.  Later this year when the revised ICH E6 (R2) guidance goes into effect we will have even more incentive to adopt RBM!

  • How To Enhance Efficiencies In Clinical Development And Market Approval
    How To Enhance Efficiencies In Clinical Development And Market Approval

    Once a sponsor has completed research and clinical trials and believes enough evidence is available on the safety and effectiveness of the new drug, the final step of the development process is to submit an application to regulatory authorities to gain approval for marketing the product. The application must contain data outlining the technical specifications of the product, as well as statistical analyses demonstrating the safety and efficacy of the new molecular entity as evidence of the acceptable benefit:risk profile.

  • TransCelerate Companies Lead The Way In Adopting Risk-Based Monitoring
    TransCelerate Companies Lead The Way In Adopting Risk-Based Monitoring

    I recently had the opportunity to attend DIA. While listening to the panelists, I realized TransCelerate companies appear to be the furthest along in their journey of risk-based monitoring (RBM), and even so, RBM is still relatively new for most of them. For the companies presenting at DIA, the main reasons given for implementing RBM were to comply with the impending ICH E6(R2) guidelines, increase the overall quality of their data, provide better oversight of patient safety and target their efforts on the areas of trials that matter most.

  • 3 Ways to Manage Excessive CRA Turnover
    3 Ways to Manage Excessive CRA Turnover

    CRA turnover is a problem in the industry. Finding qualified CRAs can be a problem for many companies. It then takes time to train and educate them on policy, procedures, and protocols. If that asset then leaves the company, you are back to square one.

  • Expect The Unexpected: Daiichi Sankyo’s Glenn Gormley Shares Post Interview Insights
    Expect The Unexpected: Daiichi Sankyo’s Glenn Gormley Shares Post Interview Insights

    I first met Glenn Gormley, M.D., Ph.D., at the 2014 PhRMA’s (Pharmaceutical Research and Manufacturers of America) annual meeting in Washington, D.C. At the time, I was engaged in a conversation with James (Mit) Spears, EVP and general counsel for PhRMA, and so my discussion with Dr. Gormley was brief. However, our encounter reminded me of an idea I once had for doing an article about Daiichi Sankyo. Though the company has a lengthy history, it had little experience in the area of oncology R&D. As Gormley is the senior executive officer and global head of R&D at Daiichi Sankyo Co., Ltd., as well as chairman of the board, executive chairman and president of Daiichi Sankyo, Inc, I thought perhaps he could share some insight on the company’s approach to entering into the field of developing cancer therapeutics. We conducted our formal interview on June 30, 2014. It resulted in the September 2014 Life Science Leader magazine cover feature — How Daiichi Sankyo Is Venturing Into The Unfamiliar Terrain Of Oncology R&D.

    As is my custom, I provide interviewees with questions in advance to guide our discussion. After an article is published, it is rare for me to revisit these questions. Further, it is unheard of for me to receive legally approved written responses to my interview questions — especially after an article is complete. But with Glenn Gormley, I have come to expect the unexpected. What follows are the previously unpublished written responses to my interview questions, which serve to shed additional insight into Daiichi Sankyo’s approach to entering the field of oncology drug development.  

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LIFE SCIENCE INDUSTRY EVENTS

Partnerships in Clinical Trials 2016 October 5 - 7, 2016
PCT Loft at the Boston Convention and Exhibition Center (BCEC), Boston, MA
Pediatric Clinical Trials: Special Considerations and Requirements October 6, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Biosimilars: Preparing For Opportunities And Challenges October 11, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Medical Device Design Controls 101 – A Practical Crash Course October 12, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance October 13, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
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TRAINING COURSES

Pediatric Clinical Trials: Special Considerations and Requirements October 6, 2016
1pm-2:30pm EDT, Online Training
Biosimilars: Preparing For Opportunities And Challenges October 11, 2016
1pm-2:30pm EDT, Online Training
Medical Device Design Controls 101 – A Practical Crash Course October 12, 2016
1pm-2:30pm EDT, Online Training
The Top Method Validation Mistakes – And How to Avoid Them October 14, 2016
1pm-2:30pm EDT, Online Training
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