Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Predictive Modeling Of Transmitted Wavefront Error In High-Performance Optical Coatings

  When interferometric testing isn’t possible, an analytical, spectral-based model predicts coating-contributed transmitted wavefront error with confidence, enabling compliance and control for advanced optical systems.

• Design Testing Strategies To Develop A Drug-Device Combination Product

  Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.

• Expert Guidance For EU Gene Therapy And Companion Diagnostic Trial Regulations

  This playbook provides a concise yet comprehensive roadmap for navigating Europe’s multifaceted regulatory environment when conducting gene therapy trials involving GMOs and CDx.

• Biostatistics And Programming — More Than Just Clinical Trials

  See how our biostatisticians and programmers successfully ingested, cleaned, and analyzed the data, ultimately providing a small biotech company with several interesting and actionable measures.

• Patient-Defined Recruitment: The Movement Advanced By COVID-19

  The pandemic forced the pharmaceutical industry to reimagine how we recruit patients to clinical trials – and it's delivering significant benefits to sponsors who embrace these changes.

• AMERICAN Plays A Role In Rebuilding Puerto Rico's Infrastructure

  AMERICAN is helping rebuild Puerto Rico’s vital water infrastructure after Hurricane Maria, supplying American-made products to strengthen resiliency for 3.5 million residents and millions of annual visitors.

• Designing More Representative Trials Through Strategic Planning

  Strategic planning for representative clinical trials improves outcomes, regulatory alignment, recruitment efficiency, and commercial value by ensuring study populations mirror real-world patients.

• 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.

• Strategic Pre-IND Consulting For Gene Therapy In Rare Leukemia

  Learn about the collaborative efforts of an innovative biotech startup and Ergomed Consulting to overcome challenges in the pre-IND phase for a novel gene therapy targeting a rare form of leukemia.

• What Does The New FDA DHT Guidance Mean?

  In December 2023, the FDA released the final version of its digital health technologies guidance, outlining the facilitated use of sensor-based DHTs and wearables in clinical investigations.

• Accelerating SARS-CoV-2 Immunotherapy Speed To Clinic

  A clinical-stage biotherapeutics company developing a COVID-19 immunotherapy searched for a solution to the difficulties it faced in scaling up its manufacturing operations due to limited resources.

• Handling Demanding Active Ingredients Safely And Efficiently

  See three flexible Optima fill‑finish and syringe assembly systems to boost performance, accuracy, and scalability, enabling efficient processing of diverse formats and supporting rapid CDMO growth.