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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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Clinical Trial-Specific Travel Programs as a Patient Retention Tool

For many patients, participating in a clinical trial is a major endeavor. Depending on the protocol requirements, study visits can be exhausting. There are a number of reasons why a patient may choose to participate in a trial only to drop out. Conversely, there are several approaches to proactively try to prevent this from happening. There are various methods professionals implement for patient retention. This white paper explores patient travel services as one patient retention strategy.

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Clinical Trial-Specific Travel Programs as a Patient Retention Tool

The Rare Disease Patients Experience

When planning a clinical trial for a rare disease, it is important to have a holistic understanding of your patient population. You want to be aware of where your patients are coming from, and what it is like to walk in their shoes. These patients need your trial just as much as you need them; even from the earliest stages, conceptualize your rare disease trial as an altruistic relationship between the patient population and your study.

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News and Press Releases

Sphere Fluidics expands into additional facility at Granta Park in Cambridge, UK

New offices at leading science hub support the Company’s rapid growth following recent investment New facility is in addition to headquarters at Babraham Research Campus, Cambridgeshire, UK and offices in Monmouth Junction, New Jersey, USA
More info >>


White Papers

Clinical Trial-Specific Travel Programs as a Patient Retention Tool

For many patients, participating in a clinical trial is a major endeavor. Depending on the protocol requirements, study visits can be exhausting. There are a number of reasons why a patient may choose to participate in a trial only to drop out. Conversely, there are several approaches to proactively try to prevent this from happening. There are various methods professionals implement for patient retention. This white paper explores patient travel services as one patient retention strategy.
More info >>


Industry Events

CPhI Worldwide

5-7 November 2019, Frankfurt, Germany

Join the World's Largest Pharma Event As it Celebrates its 30th Anniversary! Taking place from 5-7 November 2019 in Frankfurt, Germany, the event will bring together more than 45,000 visiting pharma professionals from around the globe and over 2,500 exhibiting pharma companies from every stage of the pharmaceutical supply chain - from ingredients and machinery to outsourcing services, packaging and more!
More info >>

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