3 Common Clinical Trial Models and Tips for Choosing the Right One

Posted by Chad Birt on Sep 21, 2021 9:00:00 AM

The last year and a half have been a whirlwind, particularly for clinical researchers. While the trial landscape is ever-evolving, efforts to “slow the spread” of COVID-19 have accelerated the process. 

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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, Clinical Research, Biotech, Pharmaceuticals, biotechnology, biostatistics, biometrics, FSP, clinical trials, online meetings, project management, Good Clinical Practice, patient enrollment, FDA inspections

4 cost-effective strategies for recruiting clinical trial participants

Posted by Chad Birt on Aug 23, 2021 8:00:00 AM

Designing and implementing a clinical trial is a time-consuming and costly process. In fact, a 2014 report by Aylin Sertkaya et al. submitted to the U.S. The Department of Health and Human Services found that on average:

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Topics: clinical trial strategic planning, clinical trial consulting, clinical trial remote services, Clinical Research, Pharmaceuticals, clinical trials, patient enrollment, patient recruitment

FDA Inspections - What They Are and How to Prepare

Posted by Chad Birt on Jul 20, 2021 8:45:00 AM

Food and Drug Administration (FDA) inspections are a routine aspect of operating an investigational site. Even so, the thought of an FDA auditor visiting your facility can be incredibly nerve-wracking, especially if you haven’t taken the necessary steps to prepare.

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Topics: Clinical Research, Pharmaceuticals, FDA inspections

Moving Up The Ladder in Clinical Research: 5 Keys to Becoming a Leader

Posted by Chad Birt on Jun 21, 2021 8:00:00 AM

Are you a clinical research assistant who dreams of becoming a clinical research manager or clinical operations director? When you’re just starting out, achieving a leadership position might seem like an impossible task, but if you plan ahead and map out a route, it’s absolutely possible. 

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Topics: Clinical Research, Pharmaceuticals, leadership, Business Etiquette

5 Tips for Establishing a Healthy Relationship with your CRO

Posted by Chad Birt on May 26, 2021 8:00:00 AM

A recent investigation published by JAMA found that the average cost of bringing a new drug to market is $1.3 billion. Considering only 12% of new pharmaceuticals receive FDA approval, developing these products requires large amounts of money and even more risk.

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Topics: Clinical Research, Pharmaceuticals, clinical outsourcing

Conducting Effective Project Management Meetings

Posted by Sunil Sadhwani on Sep 28, 2020 12:00:00 PM

In every organization regardless of industry, team meetings are a big part of a normal work day/week. Meetings are critical to ensure adequate communication across team members, especially in today’s environment with a highly diversified workforce that operate in multiple locations. It is certainly a common experience that some meetings are not as efficient as others and some are downright not worth the time spent at them! This blog focuses on some useful approaches for conducting effective meetings, specifically in a clinical study.

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Topics: Clinical Research, Pharmaceuticals, Functional Service Provider, clinical project management, project management

A Guide to Using Virtual Backgrounds in Zoom and MS Teams

Posted by Chad Birt on Sep 23, 2020 7:00:00 AM

A new report from the Stanford Institute for Economic Policy Research (SIEPR), found that 42% of Americans are currently working from home full-time.

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Topics: Clinical Research, Pharmaceuticals, biotechnology, online meetings

Earned Value Management in Clinical Trials: Part 2

Posted by Sunil Sadhwani on Sep 15, 2020 5:15:00 AM

An earlier blog had identified the benefits of using Earned Value Management (EVM) techniques in Clinical Studies. This synopsis provides a practical example of how to implement those techniques and making useful decisions from the available data. To support this example, a mock study with the following scope of work, budget and timeline requirements has been established:

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Topics: Clinical Research, Pharmaceuticals, biotechnology, earned value management, function service provider, clinical project management

7 Stretches to Ease Pain and Boost Work-From-Home Productivity

Posted by Chad Birt on Sep 8, 2020 7:30:00 AM

At the start of the COVID-19 pandemic, many companies asked employees to leave the office and work from home. This helps reduce the viruses’ spread in work environments but also presents unique challenges.

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Topics: Clinical Research, Pharmaceuticals, biotechnology, work from home, stretching, home office

FSP for All

Posted by Ajay Sadhwani on Aug 25, 2020 6:43:05 PM

As resource forecasting for 2021 commences, it is a good time to visit existing resourcing models to ensure they can satisfy the demands of your development pipeline. One model worthy of consideration in a variety of areas is the Functional Sourcing Model (FSP). While FSP is traditionally thought of as applicable to companies with large programs and pipelines, it is increasingly being used by smaller companies who want the same benefits afforded by the FSP model which include: risk mitigation via tighter control over operational processes, consistency, scalability and flexibility in resource management, and cost controls on clinical trial conduct.

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Topics: clinical trial, fda, Clinical Research, Biotech, Pharmaceuticals, biotechnology, FSP

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