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Empowering Global Medical Information Teams with Software Solutions - White Paper

This whitepaper discusses the attributes of high performing medical information (MI) teams operating in a global environment and discusses in detail the expertise, processes and tools required to increase the performance and value delivered by a truly global MI team. This paper further compares the key types of medical information...
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Achieving Total Safety: White Paper

ArisGlobal’s Total Safety™ solution is a comprehensive globally-accessible, globally-compliant drug safety system supporting the full range of pharmacovigilance and risk management activities from clinical trials through post authorization. It enables life science organizations, regardless of status or size, to implement effective domestic and global pharmacovigilance, clinical safety and risk management...
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Challenges in Global Pharmacovigilance - White Paper

The scenario of sustained business growth and diverse, evolving regulatory requirements to comply with across regions poses several unique challenges to the pharmacovigilance departments in Life Sciences companies. In order to successfully function across multiple markets, life sciences companies must evolve their internal processes and systems to comply with diverse...
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Resource Planning & Task Tracking

Faced with concerns such as increased regulatory scrutiny, the increasing number and complexity of clinical trials, post-marketing commitments, a narrowing drug development pipeline, resource constraints and increased costs, all sponsors of clinical trials are looking to reduce drug development costs by enhancing overall efficiency. Clinical trial costs continue to spiral...
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Investigator Selection & Site Monitoring

The life science industry is fully aware of the guidance around site monitoring and it is widely known and accepted to be one of the most costly and resource-intensive functions of any clinical trial. Currently it is estimated almost one third of the cost of a clinical trial is spent...
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Achieving Total Safety: White Paper

ArisGlobal’s Total Safety™ solution is a comprehensive globally-accessible, globally-compliant drug safety system supporting the full range of pharmacovigilance and risk management activities from clinical trials through post authorization. It enables life science organizations, regardless of status or size, to implement effective domestic and global pharmacovigilance, clinical safety and risk management...
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Preparing for E2B(R3) - Understanding the challenges, options and opportunities

This whitepaper is aimed at those involved in managing drug safety operations in life sciences organizations across the world and explores the most significant challenges facing life sciences organizations in complying with E2B(R3). It explores the approaches that an organization might want to consider to ensure compliance with the new...
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UDI – Next Frontier for Medical Device Regulatory Affairs - White Paper

The Unites States Food and Drug Administration (FDA) released the final rule on September 24, 2013 that requires most medical devices distributed in the United States to carry a unique device identifier (UDI). It also applies to certain combination products that contain devices and to devices licensed under the Public...
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The XEVMPD, One Year On – An Industry Viewpoint

It is more than a year since the date passed for the mandatory submission of data for the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) on 2 July 2012. Less than 50% of products were submitted by that date, but perhaps 85% have now been submitted. The EMA has not initiated...
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Investigator Portals: Facilitating and Streamlining Communications & Collaboration with Study Sites

The reality is that investigator site personnel are often frustrated with the lack of transparency and communication with their sponsors, leading to significant dissatisfaction and often withdrawal from current and future studies. The adoption of investigator portals gives sponsors a platform that fosters collaboration and improves site management. This white...
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Intelligent Monitoring Topic - White Paper

One of today’s big conversations in clinical research is how the conventional approach for monitoring trial conduct simply doesn’t give the best view of data to protect patient safety, comply with protocol procedures and ensure the accuracy of data collected during the conduct of a study. This conventional approach, involving...
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The IRT Landscape Regulations, Challenges and Solutions - White Paper

Nearly all companies worthy of mention have received a letter containing one or several of these notifications: “You do not consistently report Adverse Drug Experiences (ADEs) within 15 days of initial notification…” “You do not have adequate written procedures for managing from all sources…” “You have failed to maintain records...
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