Login Register
Life Science Training Institute
  • WEBINARS/eLEARNING
    • Live Courses/Webinars
    • On-Demand Courses/Webinars
    • By Category
      • Clinical Trials (GCP)
      • Manufacturing
      • Medical Devices
      • Regulatory
      • R&D
      • Leadership & Training
    • eLearning
      • Clinical Pathways
      • DIGR-ACT: Critical Thinking Skills for Clinical Trials
    • LSTI Learning Library
    • Training Voucher Packages
    • Checkout
  • Custom Training
    • Live Training
    • Elearning Solutions
    • LSTI Corporate Learning Library
    • CRA Academy
  • Articles & Resources
  • About LSTI
    • LSTI Leadership
    • LSTI Instructors
    • Contact Us
    • Connect with LSTI
    • Frequently Asked Questions
  • Connect
  • WEBINARS/eLEARNING
    • Live Courses/Webinars
    • On-Demand Courses/Webinars
    • By Category
      • Clinical Trials (GCP)
      • Manufacturing
      • Medical Devices
      • Regulatory
      • R&D
      • Leadership & Training
    • eLearning
      • Clinical Pathways
      • DIGR-ACT: Critical Thinking Skills for Clinical Trials
    • LSTI Learning Library
    • Training Voucher Packages
    • Checkout
  • Custom Training
    • Live Training
    • Elearning Solutions
    • LSTI Corporate Learning Library
    • CRA Academy
  • Articles & Resources
  • About LSTI
    • LSTI Leadership
    • LSTI Instructors
    • Contact Us
    • Connect with LSTI
    • Frequently Asked Questions
  • Connect
Capacity & Competency Of The Clinical Research Workforce — Today & Tomorrow

It’s not simply an issue of supply and demand. It’s closer to life and death. Put bluntly, we may not be able to keep up with future clinical trial demand because our workforce isn’t growing fast enough. In fact, by some metrics, we’re already falling behind.

Posted in: Clinical, Training,
Tags: clinical research, clinical trial, CRO, drug development, workforce,
How To Accelerate Adoption Of Patient Technology In Clinical Trials

Although the benefits of implementing it in clinical studies are evident, patient technology has yet to make a clear entrance into the clinical arena, as many trials continue to rely on traditional research methodology.

Posted in: Clinical,
Tags: CRO, digital technology, patient technology, PT, PT adoption,
How To Combine Quality Management With Risk-Based Monitoring In Clinical Trials

It is important to understand why risk-based monitoring (RBM) alone is not enough for a trial to succeed and what the industry can do to extend the use of risk-based strategies to ultimately support improved data quality and increased patient safety in clinical trials.

Posted in: Clinical,
Tags: CRO, RBM, RBQM, risk-based monitoring, risk-based quality management,
Adverse Event Reporting On Social Media — What You Need To Know

Adverse events (a suspected reaction to the API or to the API in combination with prescribed medicines or environmental factors) are, naturally, a challenging situation for patients in a clinical trial and may, in rare cases, become severe or even fatal. For sponsors, contract research organizations (CROs), and logistics partners, early notification and accurate information is vital to understanding and responding to a suspected adverse event. What happens if the patient goes off protocol and turns to social media?

Posted in: Clinical,
Tags: adverse events, API, CRO, social media,
A Simulation-Based Approach To CRO Selection

Protocol or clinical trial simulations have been on the radar screen of the industry for quite some time as a technique for optimizing trial design and decision making.

Posted in: Clinical,
Tags: CRO, CRO selection, modeling, simulations,
CRO Partnerships 101: What Sponsors Need To Know

Much of the focus these days, especially after the release of ICH E6(R2), has been on how Sponsors can better monitor and oversee the performance of their CRO partners. This discussion, and resulting effort, around CRO oversight is worthwhile and useful, but too often it is narrowly focused on metrics. A holistic approach to successfully partnering with CROs is needed, starting with the initial assessment of outsourcing drivers all the way through to trial completion.

Posted in: Clinical, R&D,
Tags: CRO, partners, sponsors,
Strategies For Effective Risk And Capability Assessments When Choosing A Clinical Provider

Recent revisions to the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice, as outlined in ICH E6 (R2), have provided an impetus for sponsors to reevaluate their oversight and quality management processes throughout the clinical development process.

Posted in: Clinical,
Tags: CRO, ICH, ICH E6 (R2), oversight, sponsors,
5 Keys To Establishing Quality Partnerships Between Sponsors And CROs

What is the cost of a failed partnership between a pharma company and its CROs? Is it financial? Research and development time?

Posted in: R&D,
Tags: CRO, sponsor,
How To Negotiate Study Budgets Like A Pro

Are you a clinical site that finds budget negotiations with a clinical research organization (CRO) or sponsor an uphill battle? Or do you work at a sponsor or CRO where you feel sites are making up study budget numbers or are never happy with any budget proposal?

In this article, I’ll share insights on how sponsors and CROs set up overall study budgets and discuss five secrets to getting your dream budget approved.

Posted in: Clinical,
Tags: budget, CRO, sponsors,
Should You Bring Site Management And Monitor Oversight In-House?

When a pharma or biotech sponsor company engages with a contract research organization (CRO) and other service providers, it develops a list that details which organization is responsible for each task to be conducted. The degree to which a small to midsize sponsor has the expertise and the resources internally to manage a task, as well as budgetary constraints, will dictate which tasks it delegates and which it keeps in-house.

Posted in: Clinical, Manufacturing, R&D,
Tags: CRA, CRO, oversight, site, sponsor,
  • 1
  • 2
  • Next

Upcoming Live Courses

  • China GCP 2020: Understanding and Implementing New Compliance Requirements
  • How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer
  • It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020
  • Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation

Product categories

  • Coronavirus / COVID-19
  • Uncategorized
  • Clinical Trials (GCP Training)
  • Introductory Pharma Courses
  • IT & Data Integrity for Pharma
  • Leadership & Training
  • Live Webinars
  • Manufacturing (GMP)
  • Medical Device Training
  • On-Demand Courses
  • Quality
  • Regulatory & Compliance
  • Research & Development
  • Special Packages

About Us

The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

EMAIL COMMUNICATIONS

Get LSTI Email Communications straight to your inbox. Sign Up Here

Contact

  • 101 Gibraltar Road, Suite 100 Horsham, PA 19044
  • 215-675-1800 (option 3)
  • info@lifesciencetraininginstitute.com

Course Categories

  • Clinical Trials (GCP Training)
  • Coronavirus / COVID-19
  • Introductory Pharma Courses
  • IT & Data Integrity for Pharma
  • Leadership & Training
  • Live Webinars
  • Manufacturing (GMP)
  • Medical Device Training
  • On-Demand Courses
  • Quality
  • Regulatory & Compliance
  • Research & Development
  • Special Packages

Meet Our Instructors

Footer logo
Copyright © 1996 - 2020 VertMarkets, Inc. All Rights Reserved.
  • Webinars
  • Custom Training
  • About LSTI
  • Privacy
  • Terms
Search
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.Ok