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WHITE PAPERS AND CASE STUDIES

• Elevating Diverse Patient Voices To Inspire Clinical Trial Participation

  Explore the innovative approach taken during this clinical trial partnership to address the underrepresentation of minority communities in clinical trials through digital storytelling.

• Solid-State Characterization Of A Small Molecule API

  Ensuring the consistency and purity of the API is paramount when developing a new drug. Learn about the importance of CRO partnerships when facing tight deadlines and complex scientific hurdles.

• Preparing The Next Generation Of Clinical Research Professionals

  Explore the live EDC platform that enabled Durham Tech to create a model for future-forward, hands-on education in clinical research.

• The Untapped Power Of Real-World Data And AI In Pharma Commercialization

  Harnessing RWD in commercialization bridges the gap between approval and patient access, equipping companies with actionable intelligence to deliver life-changing therapies to more patients.

• Strategies For Post-Approval Lifecycle Management And Local PV

  If you are unsure of how to navigate your post-approval regulatory journey, an experienced regulatory services partner can provide support to help you identify and achieve post-approval goals.

• Current Strategies For Enhancing Bioavailability

  Explore key strategies for enhancing bioavailability of poorly soluble drug compounds, including spray drying, particle size reduction, and lipid-based formulations supported by solid-state analysis.

• eSource Purpose Is Not Just To Complete The EDC

  Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.

• 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.

• FDA Recommendations For Gene Therapy For PMDs

  Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

• How Vanguard Clinical Harnesses CDMS/EDC For Faster Results

  Uncover how this CRO was able to stay agile by choosing a CDMS/EDC partner that prioritized sponsor needs and streamlined operations to achieve top-tier results swiftly.

• Tablet Manufacturing Technologies For Solid Drug Formulation

  Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.

• The Business Case For EHR eSource In Clinical Trials

  Examine how manual data collection challenges prompted the adoption of an eSource solution that streamlined data entry, saving time and costs, reducing errors, and accelerating a multicenter phase 2 trial.