Records Management

WHITE PAPERS AND CASE STUDIES

• Advancing Cell And Gene Therapy Clinical Development In 2023

  Examine considerations on bringing together the CMC and clinical teams early in the development process, promoting transparency and communication with regulators, and increasing patient access and diversity in clinical trials.

• How Community Oncologists View CAR T-Cell Therapy Possibilities And Challenges

  Learn how a partner with innovative solutions aimed at overcoming the barriers that limit the real-world impact of CAR T-cell therapy can make these advanced therapies more accessible and affordable.

• The Role Of The Technical Transfer Executive Sponsor

  Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.

• Seizing Market Share Pre-Patent Expiry: The Evolution Of A CDMO Partnership In Navigating A Paragraph IV ANDA Submission

  The dynamic pharmaceutical landscape demands agility and strategic foresight. Explore how leveraging a key partnership helped to overcome a looming patent expiry for a second-generation acne medication.

• The Future Is Now: CGT Innovation, Challenges, And Perspectives

  As CGTs advance toward clinical trials, developers face a number of challenges such as navigating a shifting regulatory landscape and employing beneficial manufacturing processes.

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• Re-Engineering A Complex Process For FDA Compliance

  Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.

• The Complexities Of Effective Patient Retention In Clinical Trials

  Identifying and enrolling the right-fit patients from the outset is essential, but so is implementing comprehensive retention strategies that prioritize patient comfort, trust, and ongoing engagement.

• A Supply Chain Management Solution Designed for Clinical Research

  In this use case, follow along the clinical supplies management journey to learn how GxP Inventory replaces fragmented, spreadsheet-based processes to optimize visibility, traceability, and compliance.

• GSK And Medable Discuss The Next Phase Of DCTs

  GSK and Medable share the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency.

• PWSA Advances By Upgrading To ROVVER X SAT II Lateral Launch Crawlers

  The ROVVER X SAT II lateral launch crawler allows Pittsburgh Water & Sewer Authority (PWSA) to traverse steep pipe inclines with ease, which previously posed challenges for the team.

• What Does Pharma 4.0 Mean To Cell and Gene Therapy Drug Manufacturers?

  Explore the benefits of Pharma 4.0 for CGT companies along with the challenges they may face when implementing the convergence of people, systems, and data within a singular network.