Sharepoint Solutions
PRODUCTS
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Applying experience, knowledge, and insights to plan and implement regulatory strategies for successful interactions with the FDA, MHRA, EMA, and other Global Regulatory Agencies.
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Ideal tool for characterizing nanoparticles
The Corning Videodrop utilizes the principles of interferometry in conjunction with microscopy to sense, detect, characterize, and track single nanoparticles in real time. The operation of this bioproduction analytical device is seamless thanks to its intuitive software interface and efficient sample handling protocol.
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1,735 eCOA & ePRO Studies Completed
eCOA and ePRO with Enrollment, eConsent, Payments and EDC integrated. Our services cover build, licensing and 24/7 support.
95%+ Patient Compliance Rate
4-8 Weeks to Deploy
190+ Validated Instruments
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CAI’s Kneat: Data Ready provides you with best-in-class content and templates created by industry-leaders, giving you a headstart in implementing your own Kneat solution.
Kneat: Data Ready offers not only templates, but a validated out-of-the-box configuration that you can tailor to your business needs. Implement your Kneat instance in less than half the time.
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Our team of experts are equipped to guide you through every step of any Inspection, especially Pre-Approval Inspections, due to the nature of their criticality.
WHITE PAPERS AND CASE STUDIES
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Container Selection For A Highly Sensitive Drug Product: A Success Story
Learn about the importance of selecting the right container for sensitive drug products and how close collaboration is crucial for avoiding commercialization delays and safety risks to patients.
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Cleanroom Recovery. Proven Results. Contamination Control Case Studies
Through this collection, review how a proven, automated solution can help facilities stay compliant, operational, and protected — whether in a crisis or during planned maintenance.
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NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission
A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).
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Catalent's Journey Of Continuous Improvement For CSV Excellence
Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.
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Fortrea Optimizes Site Matching On Retina Clinical Trials
Faced with challenges in engaging clinical trial sites within the retina research landscape, Fortrea sought a partnership that leverages RWD to streamline site feasibility assessments.
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Optimal Syringe Carton Design To Meet Drug Manufacturers' Needs
Learn about the advantages of an optimal packaging design and the resulting benefits of its implementation to the overall process.
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Designing, Selecting, And Developing Bioconjugates For Clinical Success
Accelerate the development of complex bioconjugates to unlock new possibilities for targeted therapies and advance the next generation of precision medicine.
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Expert Consulting And MRCT Strategy Rescues Oncology Program
Uncover how this strategic approach yielded significant outcomes, including uncovering missing data through IB review, streamlining dosing timelines, and achieving successful recruitment milestones.
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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.
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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).
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AqueoUS Vets Named A Manufacturing Partner For A Southern CA Water Treatment Facility
In August 2018, Aqueous Vets was selected over existing industry incumbents to supply the Granular Activated Carbon Systems (GACS) for a Southern California Water Treatment Plant.
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Innovative ASD Technology Improves Abandoned Cancer Medication
Review this case to learn how one solid dispersion technology lowered patients' pill burdens and demonstrated an improved therapeutic response for Galeterone.
NEWS
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Diasorin Submits The LIAISON NES Point-Of-Care Molecular Diagnostics System And 4-Plex Respiratory Panel To The FDA For 510(k) Clearance And CLIA Waiver7/2/2025
Diasorin announces the submission of a 510(k) premarket notification and CLIA waiver application to the U.S. Food and Drug Administration (FDA) for its LIAISON NES, a next-generation molecular POC testing platform.
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Investigating The 'Glue' That Holds Cells Together3/20/2025
Northwestern Medicine investigators have uncovered new insights into how intercellular “glue” functions to enable interactions between cells, as detailed in a study published in Nature Communications.
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FAU Tells 'Story' Of Atlantic's Sargassum Surge Using 40 Years Of Data8/28/2025
Researchers at Florida Atlantic University’s Harbor Branch Oceanographic Institute have released a landmark review tracing four decades of changes in pelagic sargassum – free-floating brown seaweed that plays a vital role in the Atlantic Ocean ecosystem.
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Securing Water Systems Against Cyber-Threats: Idaho Leads With Cyber-Informed Engineering3/6/2025
When it comes to cybersecurity research, the Idaho National Laboratory (INL) and Idaho have a relationship that dates back to the 1990s and was hallmarked in 2019 with the opening of the state-funded Cybercore Integration Center on INL’s Research and Education Campus in Idaho Falls.
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New Research To Unlock Smart Sewer Potential For Water Utilities8/20/2025
A groundbreaking research initiative led by a multidisciplinary team of engineers and utilities has been launched to address the critical need for industry-wide guidance on smart sewer system implementation.