Whitepapers

• Challenges in today’s approach to SAE reconciliation • Power of a cloud-based and source-system agnostic, data lake platform • Case study on how a large global biotech streamlined SAE reconciliation

In this eBook, industry leaders Validic, Quintiles and Duke Clinical Research Institute explore the four categories of digital health technologies--wearable fitness devices, clinical devices, sensors and applications-and discuss what each category includes, endpoints they collect and how they’re being used in trials today.

Many pharmaceutical, biotechnology and medical device companies have adopted globalization as a business model for their clinical trials. This model is especially pertinent within oncology with the number of competing trials consistently rising while patient access across North America and Western Europe has plateaued. While this geographic diversity of oncology trial sites has potential to open future markets, it also adds logistical hurdles ranging from import and export licenses to regulatory approval to variances in standard of care. This white paper explores several of the areas critical to the success of global oncology trials, including study planning, conducting feasibility and navigating regulatory submissions.

Teaming up with Eli Lilly and DrugDev Advisory Board, eyeforpharma conducted a 'State of the Industry' survey to investigate how pharma is currently leveraging data and technology and how this will change over the next 2 years. Highlights include: - Adopt a risk based approach for a cheaper way to clean your data, ensure optimum data quality and patient safety - Integrate real world and real time data for faster data generation, to quickly demonstrate value to patients and find urgent answers to unmet needs - Overcome rising R&D costs by utilizing big data to identify patient sub groups, integrate patients into research stages to better identify new biomarkers and provide more personalized treatments - See how mobile and wearable devices encourage patient participation by virtualizing parts of trials, reduce patient burden and enhance data quality

Clinical trials using electronic Clinical Outcome Assessments (eCOA) benefit from compliance rates 300% higher than paper-based studies - but some sponsor shy away from eCOA adoption due to a misconception that paper diaries are cheaper. Read our eBook to understand the frequently neglected cost calculations proving that eCOA is the cost-effective and superior data collection solution for many clinical trials.

The drug design process is a challenge in healthcare that calls for the better use of data at every turn. Download this article to uncover four ways pharmaceutical organizations and CROs can leverage patient-generated data from mobile health devices during the drug design process.