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How FSP Solutions Support Risk-Based Methodologies and Tech Innovation in Clinical Operations

PPD

A recent white paper from the PPD clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years to the point where multiple outsourcing models are now commonly utilized. Electronic medical records (EMRs), for example, exemplify the evolving role of technology in clinical trials.

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Virtualizing clinical trials to bring trials closer to patients

The Pharma Data

Explore how emerging trends in clinical trial investigations are bringing patients closer to medicine making them more patient-centric. The patient experience is an important consideration in trial design. Innovative ways regulators are implementing new clinical practices to measure the patient perspective.

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Expert Interpretation and Analysis of Regulatory Intelligence Are Key to FSP-Delivered Pharmacovigilance

PPD

Our recent white paper explores the many ways in which a functional service provider (FSP) engagement delivers key pharmacovigilance (PV) capabilities necessary across the product life span and across different geographical regions. Working with a committed and experienced FSP PV partner is often the best way to achieve success.

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Patient-Centric Strategies for Successful Oncology Trials

PPD

For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. This is why oncology trials must be built around patient needs, and sponsors need to balance the complexity of oncology trials with a patient-centric mindset. Many of these patients’ conditions are disabling.

Trials 69
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Analysis Life Sciences Thank You Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon

Agency IQ

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic.

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Evolution of Clinical Operations Drives FSP Staffing Models to the Forefront

PPD

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area. In many cases, higher levels of sponsor oversight are even required by regulation.

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Analysis Life Sciences Thank You Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform

Agency IQ

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

Science 40