Government

WHITE PAPERS AND CASE STUDIES

• How The Fast-Changing R&D Pipeline Is Amplifying The Importance Of Adaptable CROs

  Find out how major advances in the understanding of the causes of once-untreatable diseases have reshaped the global drug development pipeline over the past decade, paving the way for better health outcomes for many millions of people.

• Patient Perspectives On eConsent

  Explore how eConsent enables participants to engage meaningfully with consent documentation, addressing information dissemination, explanation, and recall challenges.

• Best Practices For Internal Quality Audits In Life Sciences

  Discover why internal quality audits are vital in the life sciences sector to ensure regulatory compliance, mitigate risks, and maintain high standards of product quality and patient safety amidst evolving challenges.

• 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.

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• Disclosure Management System: Build Or Buy?

  Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.

• Leveraging Machine-Learning For SDTM Mapping

  The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) represents trial data in a standardized format for review, but could its preparation be automated?

• Cultivate Innovation And Growth At Smart, Connected Facilities

  As the US and Europe continue to lead the way in addressing a growing demand for healthcare products, explore how the global biotechnology sector is maintaining momentum and confronting future challenges.

• Strengthening Pathways For Cell And Gene Therapies

  This report aims to spur informed discussions on the future trajectory of cell and gene therapies and their pivotal role in shaping the future of healthcare.

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• Reimagining FSP With ProPharma's RCO Model

  Begin leveraging our Research Consulting Organization (RCO) model and gain access to customized, agile, and scalable solutions that continuously evolve to meet your unique needs.

• Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing

  For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.