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WHITE PAPERS AND CASE STUDIES

• Removing The Barriers To eConsent Adoption

  eConsent technology has existed for nearly 20 years in various iterations. Read how sponsors have taken a cautious approach to using eConsent, piloting it on individual studies but refraining from incorporating it across all pipelines in clinical operations.

• Achieving A F.A.I.R. Data Management Strategy

  Recently many industry leaders have been highlighting the problems of not having F.A.I.R. data. For example, a recent report estimates that data that is not findable, understandable or has incomplete metadata introduces inefficiencies and negatively impact research quality, ultimately costing the European economy in excess of €26 billion per year. In this white paper, we explore what the F.A.I.R. principles mean in practical terms for your R&D data management strategy before describing how IDBS enables organizations to make their scientific data Findable, Accessible, Interoperable and Reusable and mitigate the costs of not being F.A.I.R.

• Amorphous Formulations For Insoluble Drugs: Rational Design & Practical Approaches On Formulation Screening & Development

  The issues associated with amorphous formulations include solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, in vitro in vivo performance, process and scale-up.

• The Evolving Role Of The GxP Archivist

  Customers and regulators expect the highest level of data integrity. This white paper asserts that storing GLP data in the cloud is acceptable, provided certain conditions are met.

• Real-World Data Powers Advancements In Cancer R&D

  Innovation in the area of oncology has taken off at a historic pace. Private industry and the FDA are relying more on big data, specifically multi-source, point-of-care, real-world data (RWD) to power clinical and economic real-world evidence (RWE) outcomes. We are experiencing more powerful, streamlined ways to bring innovations and advances to patients who need them at the point of care.

• Global Pharma Company Dramatically Improves Collaboration, Communication, And Compliance In Trials

  A Top 5 global pharmaceutical company wanted to help sites do everyday tasks more efficiently, making it easier for site staff to adhere to the protocol and deliver high-quality data. After evaluations and pilots, the company deployed IQVIA Technologies’ Investigator Site Portal (formerly DrugDev) in a 4-phase approach that delivered benefits each step of the way.

• Specialty Pharma Connects Content Management And Regulatory Compliance

  A European specialty pharmaceutical business deployed a fully integrated, closed-loop document management system that also addresses the quality and compliance requirements of regulatory bodies.

• Five Easy Investigator Payment Fixes To Improve Site Relations

  Site satisfaction is closely linked to the frequency, accuracy and timeliness of clinical trial payments. Yet making payments has long been a challenging process between sponsors and sites. This white paper reviews five common issues that delay site payments and offers recommendations to resolve these issues, improving payment efficiencies and ultimately site satisfaction.

• Navigating The Adoption Of Continuous Pharma Manufacturing

  Driving a path forward for continuous manufacturing calls for a closer look at current global challenges, any existing barriers, and the ideas and initiatives necessary to fulfill its potential.

• Choosing An EDC With A Robust API For Digital Therapeutics (DTx) Clinical Trials

  This white paper explores the importance of choosing an EDC with an API before starting a clinical trial.

• The Secret Sauce In Successful Clinical Trial Payments Programs

  More than 80 percent of sites surveyed want to get paid in 30 days, and many clinical technology companies offer specialized software solutions to help manage several components of the site payments process. However, these systems still require a large effort by the sponsor to operate. What is the secret sauce for success?

• Apps Improve Inspection Workflows And Efficiency

  The Iowa Great Lakes Sanitary District (IGLSD) is a wastewater collection and treatment facility. IGLSD's work is critical for protecting the high water quality of Iowa's Great Lakes. These lakes are part of a chain of glacial lakes that span about 15,000 acres. The Iowa Great Lakes area attracts over one million visitors a year according to the local chamber of commerce.