White Papers

Mar 20, 2017
Sponsored Content
As sponsors of clinical trials become more discerning about the strengths of individual contract research organizations (CROs), strategic alliances between CROs offer access to shared efficiencies in new geographic areas.
Mar 10, 2017
Sponsored Content
Increasingly sensitive and sophisticated pharmaceuticals and the proliferation of new regulations have made temperature control a hot topic. These issues raise concerns within pharmaceutical companies as well as with regulators. Download Almac’s ‘An eye on temperature’ article to learn more.
Mar 01, 2017
Sponsored Content
By Marken
Numerous changes in the pharmaceutical industry have affected the nature of clinical trials, which in turn have led to the evolution of systems used for the supply of clinical trial materials.
Mar 01, 2017
Sponsored Content
By Rho
This paper provides recommendations for effective use of Special Protocol Assessments (SPA) for Phase 3 including strategies for a successful SPA, tips for optimal use, and End of Phase 2 meetings as an alternative.
Feb 28, 2017
Sponsored Content
Clinical trial sponsors have an obligation to provide clinical trial results to trial participants. The Trial Results Summaries Portal offers a new approach to patient engagement and education that empowers patients and improves patient-centric communications.
Feb 03, 2017
Sponsored Content
Historically, IRT study- build processes followed a sequential, waterfall approach that introduced extra costs, time, delayed study lunch and more. Download the white paper to learn about the industry- changing, agile approach to IRT, and see how a CRO used Agile IRT to go live on a study only four and a half weeks after the original kickoff with only one UAT finding.
Jan 31, 2017
Sponsor's Content
As the pharmaceutical industry is heavily regulated, the demand for quality and sound data collection is highly recognised across all companies. Now is the time for your company to take control of your temperature and stability data. Find out how in this informative white paper.
Jan 09, 2017
Sponsored Content
With the aim of improving efficiencies in trial conduct while ensuring participant safety, regulatory guidelines have recently undergone revision. The revision to the ICH Guideline for Good Clinical Practice (E6 R2) primarily addresses quality management with a focus on risk identification, evaluation, control, review and reporting. With the pending adoption of these revised guidelines, it's time to evaluate how your organizational structure and processes will be affected.
Dec 23, 2016
Sponsored Content
By Rho
FDA’s Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review designations can reduce product approval timelines if pursued and implemented appropriately. Taking the time to understand the requirements and potential benefits of each acceleration mechanism will help you make informed decisions about what’s best for your product development program.
Nov 24, 2016
Sponsored Content
Bracket created an eBook that discusses the challenges with Alzheimer’s Disease and how the emergence of new approaches and investments in technology and research are paving a path forward.
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