White Papers

1. Innovative Strategies To Maintain Product Integrity In Biologic & Biosimilar Clinical Studies 7/8/2020

   Delays encountered during clinical studies can have a serious impact on competitive advantage, speed to market and the availability of lower-cost alternatives for patients. Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and potential for patient harm resulting from an interruption or delay in necessary clinical supply. Maintaining product integrity and reliability of supply can be especially challenging for biologic and biosimilar studies which will almost certainly require cold chain handling.

2. Adapting To The Medical Monitor: Driving Tech Adoption In Clinical Analytics 7/7/2020

   The reasons behind the physician monitors’ reluctance, and what technology needs to offer to convince monitors their work can be more efficient — quickly detecting safety signals and speeding time to submission.

3. Overcoming Clinical Data Aggregation Challenges 7/6/2020

   Learn about the challenges for Sponsors and CROs when integrating a vast array of data sources, typical relational database structures and why they don’t work for clinical analytics,  as well as the ideal clinical data aggregation solutions for continuous, automatic data consolidation.

4. The Regulatory Evolution And Data Revolution In Medical Device Development 7/4/2020

   The Life Sciences and Healthcare industries are among the most heavily regulated industries in the world. This paper looks at the current, dynamic regulatory landscape within the medical devices sector and some of the current and future changes medical device organizations will need to adhere to. The in-vitro diagnostics (IVD) sector is also going through regulatory change - a topic that is out of scope for this paper.

5. Addressing A Critical Unmet Need: Considerations For Designing And Conducting Neonatal Clinical Trials 7/1/2020

   There is significant unmet need for approved treatments for neonatal-specific conditions. With improved understanding of the unique nuances of research in this young, vulnerable population, sponsors can increase their likelihood of developing and executing successful neonatal clinical trials.

6. Standardizing Principal Investigation Delegation Records: An Alternative Approach For Sites 6/30/2020

   In 2008 the US Food and Drug Administration (FDA) published Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects. The guidance document is specifically intended to clarify the FDA’s expectations concerning the responsibilities of clinical research investigators and sponsors regarding the supervision of clinical studies in which some study tasks are delegated to investigator employees, colleagues, or third parties. This article to briefly examine these responsibilities, with a specific focus on the delegation of authority, and to present methods clinical research organizations (CRO) can implement to effectively document the delegation of those responsibilities in compliance with FDA guidelines.

7. Signed, Sealed, Delivered: Streamlining Regulatory Processes With eSignatures 6/29/2020

   Transitioning to electronic regulatory (eRegulatory) systems and electronic signatures (eSignatures) is a matter of identifying the regulations that govern the use electronic documents and signatures, understanding eSignature adoption trends in clinical research, drawing on the experience and insight of others, and applying the best practices and lessons learned in that transition.

8. Steps To Paperless Clinical Research Sites 6/29/2020

   This paper presents insight and expertise on how investigative sites can begin the transformation to digital documents, including concrete, practical suggestions for eliminating the inefficiencies inherent in printing, storing, and managing paper documents.

9. The Evolution Of The Modern Medical Monitor 6/26/2020

   There is an opportunity for medical monitors to redefine their role in a new era of tech-enabled, productivity-focused digital data analysis. In this white paper, we’ll explain what distinguishes this emerging role from its more traditional predecessor, and we’ll leave you with a keen sense of how to identify, hire, and empower a modern medical monitor to help your next study proceed toward submission more productively, and with greater data integrity, than ever before.

10. Regulatory Compliance: An Increasing Burden On Sites 6/25/2020

    As the biopharmaceutical industry strives to reduce its R&D costs and shorten timelines, it must face the fact that today’s successful drug development plans often require more clinical studies than they did a dozen years ago. But a new CenterWatch survey, sponsored by Complion, sheds some light for the first time on how, and how well, sites manage regulatory compliance.