Introducing the Reinvented FSP: Functional, Flexible, and Fractional Service Provider

Posted by Chad Birt on Oct 26, 2021 8:15:00 AM

Bringing a new drug, therapy, or medical device to market is a time-consuming and cost-intensive process. In fact, the average clinical trial takes six or seven years to complete with a typical price tag of $2.6 billion.

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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, data mangement, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, patient enrollment, FDA inspections

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

Everything You Need to Know to Start a Career in Clinical Research

Posted by Chad Birt on Apr 21, 2021 7:00:00 AM

Are you a professional in the health care or life sciences industry who wants to try something new? Does the thought of contributing to the discovery of new drugs or medical devices inspire you? If you answered yes to either of these questions, consider pursuing a career in clinical research. 

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Topics: Clinical Research, clinical research jobs, careers

6 Podcasts Geared Toward Clinical Researchers and Data Scientists

Posted by Chad Birt on Mar 10, 2021 8:00:00 AM

Podcasts have exploded in popularity over the course of the last decade. What was once a niche entertainment option is now mainstream, providing enjoyment to millions of Americans each month. 

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Topics: Clinical Research, podcast

A Brief History of Good Clinical Practices (GCP)

Posted by Chad Birt on Dec 2, 2020 7:30:00 AM

Clinical trials play a critical role in evaluating the effectiveness of medical, surgical, or behavioral interventions. They’re the go-to method when determining if a new vaccine, prescription medication, or medical device is safe and successful in its goals.

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Topics: Clinical Research, clinical trials, Good Clinical Practice

Decision Making Tools and Techniques for Use in Clinical Studies

Posted by Sunil Sadhwani on Nov 5, 2020 7:00:00 AM

Each organization has its processes and methodologies on how to vet critical decisions among its stakeholders. The criteria used for decision making are typically well defined and understood. Crisply allowing a good comparison of the options or trade space to have the decision be more apparent to the stakeholders requires some planning and creativity. This blog focuses on such techniques that may be useful to apply in Clinical Studies to make for a more engaging and efficient decision-making process. A brief introduction on the techniques is discussed and a relevant example on application of these techniques follows.

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Topics: Clinical Research, Functional Service Provider, project management, decision science

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