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Comparator Sourcing in Oncology Trials

Clinical Services International

This is an exciting time for oncology trials, year on year record numbers of therapeutics are launched and the indications for many drugs on the market are increasing rapidly. Immunotherapies and next generation biotherapeutics are being approved for more tumour types and a growing percentage of the late stage oncology pipeline are targeted biologics.

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Comparator Sourcing in Oncology Trials

Outsourcing and Insourcing: How Eurofins solves the bio/pharma industry’s challenges associated with meeting drug development timelines and budgets with restricted headcounts

Eurofins BioPharma Product Testing

Pharmaceutical and biopharmaceutical companies face a significant challenge to get their drug products developed and launched quickly, all while keeping development costs down. One of the most common ways for companies to lower development costs is to manage fixed headcounts. But when the same scope of work still needs to be completed by a designated time with fewer staff members, this presents a significant challenge. So, how do bio/pharma companies solve this ever so common challenge of increasing output while decreasing headcount? There are essentially three options: temporary staffing, outsourcing, or insourcing.

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Outsourcing and Insourcing: How Eurofins solves the bio/pharma industry’s challenges associated with meeting drug development timelines and budgets with restricted headcounts

Clinical Trials in Emerging Markets: Goldmines or Landmines?

Pharm-Olam, LLC

Over the past decade, biopharmaceutical companies have increasingly turned to emerging markets as a way to reduce clinical trial costs and timelines. Areas such as Eastern Europe, India, and Latin America—with their ready population of treatment naïve patients—can be an answer to the intense competition for patients seen in developed markets. Many of the countries within these regions may now be considered as “emerged” countries but yet, conducting trials in these regions does require some special attention and expertise. Before deciding to conduct studies in these areas, companies should have a full appreciation for the ethical, medical, regulatory, legal, and operational hurdles that must be surmounted for success. Here we highlight a number of those issues and offer our recommendations for how sponsor companies can deal with them effectively.

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Clinical Trials in Emerging Markets: Goldmines or Landmines?

The Emerging Use of Social Media in Orphan Disease Drug Research

Worldwide Clinical Trials Ltd

The use of various social media platforms, such as Twitter, Instagram, Facebook, and LinkedIn, for dissemination of clinical trial information has created a cornucopia of possibilities enabling clinical trial performance. Characterized by a people-to-people immediacy, social media permits extraordinarily adaptive modification of study information in real-time, and it does so in a highly targeted fashion.

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Risk-Based Inspection Readiness: Reducing Headaches with Advanced Preparation

The Avoca Group

So often, inspections are a major source of stress in the clinical trial environment. This is especially true when processes involved in preparing for an inspection are reactive. But, it doesn’t have to be that way. Using industry-leading practices and resources enables a proactive approach to mitigate—or even eliminate—the pain points associated with preparing for inspections.

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Risk-Based Inspection Readiness: Reducing Headaches with Advanced Preparation

Clinical Trial Disclosure Management: Build vs. Buy

TrialScope

Because software development is our core competency, TrialScope continues to make a significant investment in our technology. We employ agile methodologies to ensure that we can maintain a continuing level of responsiveness as disclosure requirements evolve across registries and regions.

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Clinical Trial Disclosure Management: Build vs. Buy

Spotlight on Quality in Study Startup

Oracle Health Sciences

This white paper addresses the growing interest in quality in clinical trial execution and how workflows play an essential role by building in the steps needed to comply with TMF guidelines, reducing downstream problems. This proactive strategy limits issues caused by siloes, yielding process improvements measurable by performance metrics.

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Spotlight on Quality in Study Startup

A Rules Based Approach to Labelling and Artwork Management

Kallik

Many organisations today are experiencing unprecedented demands from regulatory authorities and consumers alike for product labelling to be made clearer and more informative. Forthcoming regulations (including the new EU MDR regulations coming into force May 2020) also require that labelling content to be published electronically in addition to print. As companies seek to continuously differentiate themselves in established markets as well as gain entry into new territories, the increase in both volume and complexity of product and market variations will have a direct impact on labelling.

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ECCRT

ECCRT

The European Centre for Clinical Research Training (ECCRT) is a professional clinical research training provider focusing on the transfer of implementable knowledge for the day-to-day activities of our participants whether being new to the industry, starters on the job, or seasoned professionals. Our mission is to facilitate Clinical Research professionals to excel in their job for the benefit of patients. We aim to achieve this by providing clinical research professionals with competencies to develop new therapies for patients quicker & more efficiently, without jeopardizing quality and safety.

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ECCRT

What Your Clinical Study Design Reveals About Your Clinical Packaging Needs

PCI Pharma Services

As the cost and complexities of drug development increase, so do the challenges of global clinical trials. Today’s sponsors must be able to manage and coordinate multiple resources, processes, and locations with speed and accuracy to design effective and efficient clinical trials. Securing a stable supply chain to deal with the uncertainties of clinical trials is critical. One misstep can have a profound impact not only on the cost and time of your trial but also on its overall success.

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What Your Clinical Study Design Reveals About Your Clinical Packaging Needs
 
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News and Press Releases

Turkish Cargo includes Sheremetyevo Airport near Moscow to its cargo flights network.

As the fastest growing brand among the global air cargo carriers with its extensive flights network, Turkish Cargo included Sheremetyevo Airport (SVO), known as being the most important airport in Russia in terms of cargo activities, to its direct cargo flight destinations network.
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White Papers

galenIQ - The smart excipient

BENEO GmbH

galenIQ combines a multitude of outstanding characteristics and is suitable for a wide range of pharmaceutical applications. galenIQ can be used as more than just a bulk excipient. It also serves as an anti-caking agent, anti-humectant agent, stabilizer or oral care and taste agent to mention just a few additional functions.
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Industry Events

Evolution Summit

2-4 March 2020, The Meritage Resort & Spa, Napa, CA, USA

The 21st Evolution Summit is an invitation-only, premium Summit bringing leading clinical trial executives and innovative suppliers & solution providers together. The Summit’s content is aligned with key clinical trial challenges and interests, relevant market developments, and practical and progressive ideas and strategies adopted by successful pioneers.
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