White Papers

1. 2021 State Of Clinical Trial Technology Industry Report 1/4/2021

   How are clinical operations leaders making strategic technology investments in 2021 and beyond? This report provides insights from more than 200 respondents to the annual Florence State of the Industry Survey, from dozens of stakeholders who are members of the Florence Executive Advisory Board, and more than 8,500 study sites and more than 8,000 sponsors using Florence.

2. External Controls (Part II): Informed Choices Amidst A Portfolio Of Options 12/10/2020

   Regulatory concepts referable to the creation of an external control group have long been noted and occasionally implemented, particularly for diseases with severe morbidity, mortality, and unmet medical need. This white paper outlines the potential benefits and disadvantages of using an external control within a program and the key criteria from representative programs that have successfully passed industry and regulatory muster to use external controls in registrational programs.

3. Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records 12/7/2020

   Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

4. Real-World Data Powers Advancements In Cancer R&D 12/2/2020

   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.

5. Strategic Considerations For Regulatory, Operational, And Commercial Success In Dementia Research 11/30/2020

   Given the burden that caring for individuals with dementia places on both the health care system and caregivers, research and development efforts now extend beyond Alzheimer’s disease to explore a mosaic of syndromes, each of which presents unique and significant challenges, in part because so much remains unknown about the pathophysiology, clinical presentation, and course of these conditions.

6. Programs To Support Drug Development In Infectious Disease 11/23/2020

   Programs such as Generating Antibiotic Incentives Now (GAIN), its Qualified Infectious Disease Product (QIDP) Designation, and the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD), described below, were designed by the FDA to streamline development and encourage investment into targeting infections that lack effective treatments, but taking full advantage of each isn’t easy without a comprehensive knowledge of the rules, incentives and eligibility requirements.

7. Practical Considerations Of A Successful RBQM Implementation 11/22/2020

   Advances in technology, such as electronic capture and storage of study data and documentation, have accommodated the growing reliance on RBQM for clinical trials. With any new technology, there are questions about implementation and best practices.

8. The Next Generation Of Trial Master File Systems 11/20/2020

   The next generation of eTMF systems are coming into their own. They use Artificial Intelligence and Natural Language Processing (NPL) to improve efficiency, preserve one version of the truth, and maintain audit readiness. The following paper covers the current state of eTMF technology and the future level of functionality that users can now expect.

9. Preparing For A New Data Future: A Survey Of Clinical Research Technology Decision Makers 11/20/2020

   To better understand current views on technology software solutions that support clinical research and development (collectively referred to as “eClinical software solutions”), especially on a unified platform, Medidata surveyed current and former technology decision-makers representing large to mid-size pharmaceutical companies and contract research organizations (CROs).

10. Evolution Of Treatment Of Atopic Dermatitis 11/19/2020

    The Atopic dermatitis (AD) treatment paradigm has significantly evolved in the last five years. Currently, AD is an area of intense focus for clinical developers. Globally, more than 100 pharmaceutical and biotechnology companies are investigating new therapeutic solutions for AD. This white paper will explore the pathophysiology of atopic dermatitis, as well as the rationale and mechanisms of action of existing and emerging therapies for AD.