Sharepoint Solutions
PRODUCTS
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Electronic informed consent for patient-centric decentralized clinical trials.
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Our autoinjector assembly systems for any autoinjector provide scalable output rates from 2 ppm – 320 ppm. Standard or Custom engineering available.
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TrackWise Manufacturing makes it easier than ever for life sciences manufacturers of all sizes and complexities to achieve outstanding outcomes.
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25 years of Providing World-Class Medical Information Services.
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Australia is a preferred destination for early phase trials because of simple and fast regulatory stream and lucrative R&D cash refund scheme.
WHITE PAPERS AND CASE STUDIES
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The Role Of A Consulting Firm In The IND Process
Navigate the complex IND process with expert guidance and discover how early FDA engagement can accelerate your path to clinical trials.
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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.
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Pharma R&D Review 2024: Pleasant Weather Ahead
Gain insights from the 2024 pharma landscape, which reports a record-breaking 22,825 pipeline drugs, led by Pfizer's 32 new candidates and a strong focus on oncology and neurological treatments.
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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.
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Pioneering The End-To-End Decentralized Trial Experience
This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.
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CDMO Accelerates Contract Manufacturing With Electronic Batch Records
A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.
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BioIVT Collaborates With IDBS To Deploy IDBS E-WorkBook And Reduce Study Cycle Times
Learn about a collaboration that has enabled BioIVT to enhance efficiency and responsiveness to its biopharmaceutical clients.
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Patient-Focused Data Capture For Cancer Research
In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.
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AOC GMP Manufacture For A FIH Study
Successful development of AOCs for FIH studies requires robust GMP processes and efficient scale-up. A key step is careful management of a multi-day conjugation process with vital in-process checks.
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Manufacturing Transfers: Delivering 140+ Precision Medical Devices Without Missing A Deadline
Go inside a successful manufacturing transfer of over 140 Class-III silicone medical devices and on-time delivery for a top-30 OEM through expert project management and rigorous validation processes.
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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.
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Rescuing Data Integrity: A Swift Transition And Quality Transformation
Uncover how this collaboration supported timely progress toward key study milestones, enabling smoother execution and more dependable output across data management and statistical activities.
NEWS
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H2APEX And Copenhagen Infrastructure Partners Enter Into Strategic Partnership For Pioneering Hydrogen Project In Lubmin8/5/2025
H2APEX Group SCA announces that Copenhagen Infrastructure Partners (CIP) – one of the world’s leading investment companies in energy infrastructure investments – has acquired a majority stake of 70% in the first phase of H2APEX’s IPCEI-funded hydrogen project in Lubmin through its Energy Transition Fund (CI ETF I) as a strategic investor.
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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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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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Interior Cuts Red Tape To Speed Water Infrastructure In The West11/25/2025
The Department of the Interior today announced Secretary's Order 3446, which streamlines federally funded construction projects at Bureau of Reclamation facilities across the 17 Western states.
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Axim Biotechnologies Files Pre-Submission With FDA For CLIA Waiver Pathway On Lactoferrin Point-Of-Care Diagnostic Test6/24/2025
Axim Biotechnologies, Inc. a leading developer of rapid diagnostic testing for ocular and systemic conditions, today announced that it has filed a Pre-Submission (Pre-Sub Q) with the U.S. Food and Drug Administration (FDA) as the first formal step in seeking a Clinical Laboratory Improvement Amendments (CLIA) Waiver for its rapid, point-of-care Lactoferrin diagnostic test (TearScan Lf).