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

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

Benefits of Earned Value Management in Clinical Trials

Posted by Sunil Sadhwani on Aug 12, 2020 6:32:49 AM

Earned Value Management (EVM) techniques are commonly used as a disciplined process to track Key Performance Indicators (KPIs), Cost and Schedule. Typically for long duration projects which may span several major subprojects, these techniques can be extremely useful to gauge the team’s ability to adhere to a cost budget or a critical timeline for the project. A clinical study is a classic use case for applying EVM techniques as there are major subprojects within the project spanning different resource types. Additionally, the monetary value of clinical studies ranging from ~$5M in a phase 1 trial to exceeding $100M for a Phase 3 trial offer the opportunity to realize substantial financial savings through crisp execution using KPIs as benchmarks through the study.

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Topics: FSP, Functional Service Provider, EVM, earned value management, KPI, clinical trials

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