clinical research solutions

Clinical Research Solutions are designed to support the complex requirements of clinical trials from start to finish. Effective solutions help teams manage study design, regulatory compliance, and patient safety. The following articles discuss innovative strategies and lessons learned from clinical research.
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Clinical Research Solutions

Pros and Cons of Working with a CRO

A Contract Research Organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract...

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Clinical Research Solutions

What is a Clinical Evaluation Report (CER)?

If you’re starting to explore marketing your medical device in the European Union (EU) or have a medical device that is currently CE Marked, you’re becoming familiar with the term 'CER' or Clinical...

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Clinical Research Solutions

Navigating Uncertainty with the FDA LDT Rule

On May 6, 2024, the US Food and Drug Administration (FDA) issued the Final Rule regarding regulation of laboratory developed tests (LDTs). The LDT Final Rule outlines a four-year phaseout period for...

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Clinical Research Solutions

Navigating the Regulatory Maze: Clinical Data for Medical Device Approval

In the world of medical devices, particularly those categorized as moderate to high-risk, clinical data is a critical component of the regulatory approval process. This data, presented to regulatory...

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FSP Solutions

What is the FSP Model in Clinical Research?

The term Functional Service Provider (FSP) concept is highly regarded in the field of clinical research. With drug discovery and clinical trials becoming more complex, pharmaceutical firms and...

Meet the Expert: Terri Levine

Clinical Research Solutions

Meet the Expert: Terri Levine

Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...

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How Important is Biostatistics?

The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...

Meet the Expert: Demis N. Lipe

Meet the Expert: Demis N. Lipe

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Meet the Expert: Immaculich Rani

Meet the Expert: Immaculich Rani

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

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Frequently Asked Questions About Clinical Trials Registration and Disclosure

In the ever-evolving landscape of clinical trials disclosure, navigating the intricacies of registration, compliance, and ethical transparency has become more crucial than ever. Pharmaceutical and...

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EMA Policy 0070: Back on the Road to Transparency

By now, most involved in the clinical trials disclosures field are aware of the upcoming reinstatement of the European Medicine Agency's (EMA) landmark transparency regulation: Policy 0070. Policy...

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Biotech Startup Approaching IND: 5 Mistakes to Avoid While Writing a Development Plan

In the drug development process, the Investigational New Drug (IND) application holds immense significance for biotech startups. It serves as a comprehensive overview submitted to the US Food and...

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Why Decentralized Clinical Trials are the Future of Clinical Research

Decentralized clinical trials (DCTs) have emerged as a transformative approach in clinical research, offering unique benefits that challenge the traditional models. However, deciding whether to...

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Benefits of Decentralized Clinical Trials

In recent years, the landscape of clinical trials has undergone a remarkable transformation with the emergence of decentralized clinical trials (DCTs). These innovative approaches leverage technology...

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Why Partner with a CRO that has In-House DCT Capabilities?

When you need to outsource your clinical trials and decentralized visits, it can be beneficial to select a single provider that can do both. There are many synergies that come from using a single...

7 Questions to Ask When Selecting a DCT Provider

When considering a decentralized approach to your clinical trial, it can be confusing or overwhelming to identify a provider that will truly understand and support specific study needs. ProPharma...

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