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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

EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market

PCI Pharma Services

Recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) opened an investigation into a patient complaint of mold on paracetamol (acetaminophen) tablets (1). It discovered the product was shipped by sea from India to multiple companies in the UK at temperatures reaching up to 60 degrees Celsius. Labeling for paracetamol tablets typically states they should be kept below 30 degrees Celsius. In addition, MHRA discovered the humidity levels exceeded 80 percent during shipping, which is too high for the packaging that was used.

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EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market

Six Strategies to Stretch Your Limited Drug Supply for Clinical Studies

PCI Pharma Services

Bringing a new drug to market can be a heavy financial burden on any pharmaceutical company. It has become even more burdensome over the last several years as the industry pushes the boundaries of innovation. This is because newer, often more-complex therapies not only increase risk in drug development but also drive costs even higher. A recent analysis of the investment needed to develop a new prescription medicine shows the total cost can be as high as $2.6 billion (1). That number becomes even more staggering when you consider the fact that only about 12 percent of drug candidates that make it to Phase I testing are eventually approved by the FDA (2). The investment companies lose as a result may be too devastating to their bottom line to ever recover.

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Six Strategies to Stretch Your Limited Drug Supply for Clinical Studies

Another Successful Visit Against the Odds

Medical Research Network (MRN) Limited

Our dedicated team of nurses, couriers and project managers deliver, come rain or shine. Making sure a Clinical Trial visit can go ahead in the home can be a complex process, and last month bad weather nearly stopped play on an important Home Trial Support visit. Thanks to the commitment and dedication from the entire team it went ahead against the odds.

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News and Press Releases

EXTERNAL COMMUNICATION, 24 October 2019, Copenhagen, Denmark PRESS RELEASE – FLYPHARMA CONFERENCE EUROPE 2019

For its fifth annual Europe conference, FlyPharma chose Copenhagen as its host city to address the latest supply chain challenges and industry best practices, putting together a global audience of (bio)pharma and logistics professionals. The two-day conference (22-23 October 2019) aimed to discuss the collaboration and growth within Scandinavia, with a special focus on women in pharmaceutical logistics and an exploration of the industry’s digitalisation and innovation.
More info >>


White Papers

How to Reduce Costs of Specialty Pharmaceutical Shipments and Increase Patient Satisfaction

Temptime Corporation

The specialty pharmacy industry could reduce costs by $27.5 million annually (product and call center staff costs only) if visual temperature indicators were used as decision-making tools to determine if medicine should be used or returned when patients suspect heat damage. In addition, 97% of patients surveyed, who received medicine from specialty pharmacies with a visual temperature indicator included in the package, agree that they would want an indicator in all shipments and 95% agree the indicator increased their confidence in the medicines received.
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Industry Events

2020 Avoca Quality and Innovation Summit

3-4 June 2020, Amsterdam, The Netherlands

The 2020 Avoca Quality and Innovation Summit will take place 3-4 June 2020, in Amsterdam, The Netherlands.
More info >>

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