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IDMP Medicinal Product - White Paper

The definition of an ‘IDMP Medicinal Product’ can be complex and putting together information about medicinal products in the ISO IDMP data model can be quite a challenge if an organization doesn’t understand the intricacies of the data model and the levels of the product at which unique identifiers are...
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Understanding True eTMF Requirements - White Paper

Maximizing eTMF and eClinical Solutions for Improved Metrics and IRB Submissions Given that eTMF solutions have been available for a while, why is the industry still struggling and why are inspectors still complaining and issuing critical findings because they can’t find the information they need? Compared to EDC, for example,...
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Solving Data Management Problems through Unified Solutions - White Paper

“Slow and costly study builds continue to be a headache, even in the most modern electronic data capture (EDC) platforms. This is for many reasons, such as the need for expert programmers, building in the back end without instant visibility of forms and edit check outputs, inefficient spec, build, review...
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Realizing the Promise of EDC: Deriving Greater Value Through its Optimized Use - White Paper

The clinical development industry is entering a new era of change and opportunity. It faces an increasing array of drivers from the commercial, regulatory, safety and patient sectors, the likes of which have never been seen before. In response to these pressures, the industry is embracing new techniques and technologies;...
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Total Clinical - Overview Brochure

Click on the link below to view the datasheet Total-Clinical-Overview Brochure
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EudraCT Results Reporting - White Paper

Version 10 of the EudraCT database heralds the first step of a process through which summary clinical trial results will be made publicly available. “EudraCT Results Reporting: Are You Sure You’re Ready?” provides a high-level introduction into results reporting in EudraCT and how it will impact your trial disclosure requirements....
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Everything you ever wanted to know about IDMP - White Paper

The European Medicines Agency has mandated that organizations doing business in the EU will need to submit product information according to the ISO-IDMP standards by July 2016. This is however not just a European challenge, as the FDA is working on the adoption of the IDMP standard and it is...
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ライフサイエンス企業へのE2B(R3)の影響(ホワイトペーパー抜粋版)

以下のリンクからご覧になる資料は、「Preparing for E2B(R3) – Understanding the challenges, options and opportunities」ホワイトペーパーより抜粋した資料になります。 preparing-for-E2BR3_JP
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RAUM 2014 Presentations

On behalf of the RAUM 2014 organizing committee at ArisGlobal we wanted to thank you for attending the RAUM Annual Conference in May 2014 at Nice, France. We hope that you found the conference informative and worthwhile. The primary goals of this conference were to bring together users for product...
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Pharmaceutical Medical Information and Social Media

This white paper details out the potential synergies between social media and medical information practices and also explains how social media could be an exciting and effective channel for medical information teams to engage consumers and providers. Further in this paper we will also explore perspectives of various Medical Information...
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Trial Disclosure: How to Ensure Consistency and Keep Control Over Data

Trial disclosure is a fast-moving area as reflected in the changes in existing registries as well as in the emergence of new ones. This white paper examines the trial disclosure process and the value that available technology can provide to deliver greater efficiency and consistency of published data while giving...
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Medical Information Role in Pharmaceutical Industry - White Paper

This white paper details the MI function, roles, workflow, tools and related topics to give you an inside look at this critical but often overlooked and underestimated department. Whether a global pharma, emerging bio-tech, CRO, aspiring PharmD, or just an interested party, we believe you’ll get value from this new...
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