Current Edition

Current features

The Role of Confirmatory Trials After Accelerated Approval

Initially developed for the HIV/AIDS crisis in 1992, the US Food and Drug Administration (FDA) established the accelerated approval program to expedite the approval of …

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Current features

Rethinking Statistical Significance in a Rare
Disease Context

Highlights of a recent panel debate moderated by Christian K Schneider, head of Biopharma Excellence, reviewing emerging approaches to clinical data collection where patient populations …

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Current features

Data Protection and Clinical Trial

The highly regulated nature of the pharmaceutical industry means that organisations within this sector are no strangers to the requirement to abide by the various …

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Current features

The Year Ahead for Life Sciences Regulatory
Operations

Amplexor asked some of its closest partners for their views on the most important developments in Life Sciences regulatory operations in 2022, and for their …

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Current features

Beyond modernisation– Unlocking the Value
of Regulatory Information Management

Biopharmaceutical companies are now at an important inflexion point. Most have completed their modernisation of the Regulatory function globally, bringing improvements to efficiency, according to …

Continue Reading →

Current Edition

Current Features

Current Features

Current features

The Role of Confirmatory Trials After Accelerated Approval

Initially developed for the HIV/AIDS crisis in 1992, the US Food and Drug Administration (FDA) established the accelerated approval program to expedite the approval of drugs for serious …

Read More →
Current features

Rethinking Statistical Significance in a Rare
Disease Context

Highlights of a recent panel debate moderated by Christian K Schneider, head of Biopharma Excellence, reviewing emerging approaches to clinical data collection where patient populations are small. Biopharma …

Read More →
Current features

Data Protection and Clinical Trial

The highly regulated nature of the pharmaceutical industry means that organisations within this sector are no strangers to the requirement to abide by the various strict rules and …

Read More →
Current features

The Year Ahead for Life Sciences Regulatory
Operations

Amplexor asked some of its closest partners for their views on the most important developments in Life Sciences regulatory operations in 2022, and for their predictions for 2023. …

Read More →
Current features

Beyond modernisation– Unlocking the Value
of Regulatory Information Management

Biopharmaceutical companies are now at an important inflexion point. Most have completed their modernisation of the Regulatory function globally, bringing improvements to efficiency, according to newly-published Gens & …

Read More →
Current features

Next-level Clinical Trial Technology Can
Avoid Dropouts and Accelerate Drug
Development

Despite the recent shift to hybrid and decentralised clinical trials (DCT), low enrolment, poor retention, and outdated processes are still holding research back. But it’s not the technology …

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Company Profiles

Catalyst Clinical Research

Catalyst is a clinical research organization (CRO) that provides highly customizable solutions to the global biopharmaceutical industry through two established, branded solutions: Catalyst Oncology and Catalyst Flex The company …

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PCI PHARMA SERVICES

PCI is a leading global CDMO, truly spanning the cycle, connecting development and commercialization, de-risking the supply chain providing clients with integrated end-to-end drug development, …

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Tower Cold Chain

Tower Cold Chain is a leading provider of temperature-controlled solutions to the global pharmaceutical, biotech and life-science industries. Working with businesses since 2007 to protect …

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Ramus Medical Ltd

Ramus Medical Ltd

Ramus Corporate Group is a union between Ramus Medical and Medical Diagnostic Laboratory Ramus. Ramus Medical is a full service Contract Research Organization based in …

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Trilogy Writing & Consulting

Meet the Masters of Medical Writing At Trilogy, medical writing is our passion. As specialists in regulatory documentation, we provide a service that is more …

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SGS

SGS

SGS, LIFE SCIENCES – CLINICAL RESEARCH SGS is a leading life sciences CRO providing clinical research and bioanalytical testing with a specific focus on early …

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