Company Category: Digital Clinical Trials

Sikich

Sikich LLP is a business and technology consultancy who’s close to 1,500 team members provide advisory, consulting, and technology services to clients in life sciences, manufacturing, professional services, and other industries. The company’s life sciences practice spans the industry and supports more than 200 life sciences clients, including biotechnology and biopharmaceutical companies, CROs, and lab diagnostic companies. As a leading life science technology consultant, we can help you streamline operations and ensure compliance, allowing stakeholders to do what they do best: develop new medicines for patients who need them. | At Sikich, we empower life sciences organizations through strategic planning, regulatory expertise, and digital modernization. From inception to commercialization, we specialize in planning, regulatory, quality, and compliance, leveraging cutting-edge technologies like Oracle NetSuite, Honeywell’s TrackWise Digital, and Kneat’s solutions to streamline operations and accelerate innovation. Our tailored approach combines deep industry knowledge with advanced digital tools, ensuring compliance, enhancing efficiency, and reducing time-to-market for life-changing therapies. A focus on built in audit trails, roles-based control and automated reporting ensure compliance with FDA 21 CFR Part 11, SOX and EU Annex 11. With a commitment to precision, integrity, and transformation, we help companies navigate complex regulatory landscapes and embrace the future of life sciences with confidence. Plan smarter. Modernize faster. Innovate with impact.

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SHARP

Sharp Corporation is an electronics manufacturer founded in 1912 and headquartered in Osaka Japan. Sharp has established itself as an industry leader in air conditioning, heating, and air purification in Japan since its first ductless mini-split in 1968. Sharp is seeking for more regional distributors to expand its heat pump business in North America after providing heating solutions for over 14 years in the area. Visit booth #SL1919 for further information. | Sharp is a leader in commercial packaging, clinical services & sterile manufacturing. For 70+ years, we’ve provided solutions to pharma & biotech clients from phase I trials through to commercial launch & lifecycle management. With facilities in the United States, United Kingdom, Belgium & the Netherlands and 30+ clinical depots globally, covering every region of the world, our experience is your strength. Our full complement of integrated services includes research and development, clinical manufacturing, small-scale sterile development and manufacturing services, primary and secondary packaging of both investigational and commercial product, package design, serialization and aggregation, storage, distribution and clinical IRT. Sharp also offers Qualified Person (QP) services to meet the complex regulatory demands of drug product release in the EU and UK. | Sharp is a leader in commercial packaging, clinical services & sterile manufacturing. For 70+ years, we’ve provided solutions to pharma & biotech clients from preclinical through to commercial launch & lifecycle management. With facilities in the United States, United Kingdom, Belgium & the Netherlands and 30+ clinical depots globally, covering every region of the world, our experience is your strength. Our full complement of integrated services includes research and development, clinical manufacturing, sterile development and fill/finish services, primary and secondary packaging of both investigational and commercial product, package design, serialization and aggregation, storage, distribution and clinical IRT. Sharp also offers Qualified Person (QP) services to meet the complex regulatory demands of drug product release in the EU and UK. | Sharp Imaging and Information Company of America (SIICA) is a division of Sharp Electronics Corporation, the U.S. subsidiary of Japan’s Sharp Corporation, a global technology company which has been named to Fortune magazine’s World’s Most Admired Company List. Sharp strives to help businesses achieve Simply Smarter work by helping companies manage workflow efficiently, create immersive and engaging environments, and increase productivity. SIICA offers a full suite of secure printer and copier solutions, commercial displays and projectors, Dynabook laptops, management and productivity software and fully managed services. As a total solutions provider, Sharp has a reputation for innovation, quality, reliability, and industry-leading customer support expertise. We look forward to seeing you at Infocomm 2025!

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Pheiron GmbH

x | Pheiron is an AI research lab working towards a future of deterministic drug development. We can’t reliably predict which biology will work in humans. Pheiron builds causal models on primary human data to generate biological alpha: knowing what biology will work early enough to change the outcome of a drug program.

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Pharmtrace Klinische Entwicklung GmbH

pharmtrace is an independent CRO providing strategies and solutions for clinical trials. pharmtrace offers flexible services and a global reach for studies with imaging endpoints, radiopharmaceuticals, and radiological interventional procedures. pharmtrace’s experienced team and international medical specialists network ensure that your investment in medical imaging, radiopharmaceuticals and radiological interventions delivers meaningful data. With our GCP compliant image management platform (ERICA) we support you to generate robust data to convince authorities and decision makers, and to achieve your development target. pharmtrace’s customers include biotech and academia, as well as internationally engaged pharmaceutical companies and device manufacturers. | Full-service clinical trial management by a team that understands imaging and radiopharmaceuticals as deeply as clinical operations. pharmtrace is a private, independent contract research organisation for the pharmaceutical and medical device industry. We focus on clinical studies where diagnostic imaging and/or nuclear medicine approaches are a major component for efficacy or safety assessment — including RECIST-based oncology trials, therapeutic radiopharmaceutical programmes, and medical device investigations. Our clients are global pharmaceutical companies, biotech firms, and academic sponsors across North America, Europe, and Australasia. We have managed clinical trials across oncology, neurology, cardiology, and other therapeutic areas — from first-in-human exploratory studies through Phase 3 registration trials and Phase 4 post-marketing commitments. In each, imaging expertise was built in from the protocol stage, not retrofitted. Our experience includes studies that have supported marketing authorisation applications to FDA and EMA. We know what these submissions require and design our processes accordingly from the outset. pharmtrace’s Imaging Core Lab provides comprehensive support for all imaging aspects of clinical trials and medical device investigations. Whether your study applies RECIST 1.1 or iRECIST for tumour response in oncology, PERCIST for PET-based assessment, quantitative MRI endpoints in neurology, SPECT imaging in cardiology, or quantitative imaging for a medical device investigation — we standardise, collect, quality-control, and independently review images with the rigour that regulatory submissions require. Our proprietary ERICA platform, validated to GAMP5 Category 5, serves as the single environment for DICOM image storage, technical and medical QC, and blinded read sessions — with per-study configuration validation for every project. We support sponsors at any stage — from early imaging strategy and endpoint selection through regulatory meeting preparation and marketing authorisation support. Our advice is grounded in operational experience, not theory.

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NEUROPHET

NEUROPHET Inc., Seoul, Republic of Korea, with expertise in neuroscience. We have been focusing on developing and providing innovative medical solutions for helping patients suffering from neurological diseases. To achieve the mission, we have applied state-of-the-art AI technologies to our expertise in neuroimaging, brain modeling and neuromodulation. We are conducting research in imaging-based biomarkers for Alzheimer’s disease (AD), which will be valuable tool for clinical trials (surrogate biomarker for drug response and disease progression) and companion diagnostics for AD therapeutics and furthermore, global standardization for AD staging and diagnostics. Neurophet provides medical-grade solutions approved by international regulatory bodies. | Neurophet Inc. develops advanced AI-powered neuroimaging solutions to enhance the diagnosis, monitoring, and treatment planning of neurological disorders. Its flagship products—AQUA AD, AQUA, and SCALE PET—deliver precise, quantitative insights into brain atrophy, lesion dynamics, and imaging biomarkers, including those associated with amyloid-targeted therapeutics (ATT) and amyloid-related imaging abnormalities (ARIA), through MRI and PET imaging. | Neurophet is a specialized company developing AI-powered brain imaging analysis solutions and therapeutic medical devices, covering the full cycle of neurological care — from MRI and PET analysis to wearable brain stimulation devices. We support medical institutions with AI-based imaging for diagnosis and treatment monitoring, and provide standardized central imaging services for global pharmaceutical clinical trials through our Imaging Core Lab (ICL). From the clinical frontline to global clinical trials, Neurophet is advancing as a global leader in neurological imaging analysis.

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Celestia Diagnostics

Celestia Diagnostics develops lab tests and clinical bioinformatics systems to aid in the diagnosis and treatment of chronic complex conditions such as Long COVID, ME/CFS, and POTS.

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Apxora

APXORA is an agentic AI SaaS platform supporting pharma, biotech, and medtech organizations by connecting financial and commercial decisions with clinical development and R&D through deployable, enterprise‑ready AI workflows. APXORA offers four core solutions: Asset Lifecycle Manager, Portfolio Manager, Clinical Navigator and Research Nexus. They can be deployed independently or as a connected suite, helping teams break down silos, meet security requirements, and adapt seamlessly to existing infrastructure. Together, these solutions create a built-in workflow that not only mirrors but optimizes decision-making. The result is a continuously connected closed loop system spanning early research through portfolio strategy. The platform can be extended with new tools or integrated with legacy systems, forming a living digital twin of the enterprise that strengthens connectivity, accelerates decisions, and improves efficiency at scale. Asset Lifecycle Manager The platform is a dynamic platform built to manage the full lifecycle of strategic assets. From inception to retirement. It enables users to model, monitor, and optimize the performance of each asset across its entire lifecycle. With advanced simulation tools and powered by agentic AI, users can evaluate how market dynamics, pricing strategies, competitive changes, and operational variables impact asset viability over time. Portfolio Manager The platform represents the culmination of a fully integrated decision support ecosystem, connecting every stage of enterprise value creation from early research signals to long term portfolio performance. Built for complex, innovation driven organizations, the Enterprise Suite fosters seamless collaboration across R&D, asset lifecycle management, and strategic planning. Clinical Navigator Clinical Navigator helps clinical teams design, simulate, and optimize trials using patient-level digital twins and predictive models. Built on generative AI and custom LLMs, it enables faster, smarter trial design and identifies regulatory analogs from FDA and EMA landscapes to guide trial planning. Research Nexus Research Nexus enables teams to generate hypotheses, identify novel targets, and explore drug repurposing opportunities. It provides a custom-built knowledge graph as the foundation for agent orchestration and LLM capabilities, unifying scientific and clinical data for rapid exploration and decision-making.

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Adlib Software

Adlib Software

Adlib is the accuracy authority in AI-driven document automation for high-stakes, regulated industries. As the critical layer in front of IDP systems, LLMs, and RAG pipelines, Adlib ingests messy, multi-format content and transforms it into AI-ready, machine-navigable pipelines. The platform normalizes file types, applies fidelity-preserving rendering and advanced OCR, classifies and chunks content with citation anchors, enriches it with metadata, extracts information into structured data contracts, and validates outputs against each organization’s business and compliance rules. This results in compliant, searchable outputs and high-quality structured data that downstream systems can trust. Across Life Sciences, Energy, Insurance, Financial Services, and other regulated sectors, enterprises rely on Adlib to reduce human-in-the-loop reviews, increase retrieval precision and model accuracy, accelerate decision-making, and lower processing costs. For more than two decades, organizations such as Pfizer, Swiss Re, IAG, and JP Morgan have trusted Adlib to turn unstructured content into reliable, audit-ready data that safeguards compliance, drives performance, and ensures every decision is precise and AI-ready.

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