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WHITE PAPERS AND CASE STUDIES

• Success Factors For Launching Products With Orphan Drug Designation

  Orphan drug designation offers a number of financial incentives to pharmaceutical companies. Learn more about the potential hurdles of orphan drug development and the opportunities to maximize your success.

• Microbial Challenge In-Use Studies

  Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

• 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.

• Alzheimer's Study Involving Home Infusions Exceeds Expectations

  Gain insight from this Phase 3 global clinical trial focused on pre-clinical Alzheimer’s Disease where adult patients received one-hour intravenous infusions every month for 4.5 years.

• Solving The Silicone Challenge In Pre-Fillable Syringes

  Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

• The Impact Of Artificial Intelligence On CQV

  AI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.

• Advancing Rare Disease Clinical Trials With Point-Of-Need Eye Assessments

  During the COVID-19 pandemic, Applied Genetic Technologies Corporation (AGTC) faced significant hurdles in enrolling participants due to travel restrictions and site limitations.

• The EMR Interoperability Dream Vs. Clinical Research Reality

  Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Streamline Recruitment With Confidence

  Transform your clinical trial recruitment with a service that delivers faster, more cost-effective enrollment, particularly for hard-to-reach populations.

• 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.

• On-Demand Payment Technology Offers Accuracy, Speed, & Transparency

  Review current grant payment practices and how new software tools can transform the process, efficiently solving the problem that first gave rise to sponsor-funded escrow accounts.