We understand that labeling and packaging your trial drug is an intricate and vital piece of your project. While the clinical supplies packaging industry has changed substantially over time, we make sure our experts keep up-to-date and understand how these changes affect your packaging needs.
Our GMP-compliant storage capacity, cold-chain logistics expertise and global distribution capabilities means we can fulfill your unique needs no matter the size or scope of your project.
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specializes in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 97 locations in 38 countries and has approximately 13,100 employees.
TrialScope Clinical Trial Transparency Service (CTTS) enables clinical trial sponsors to engage with patients and the public via a user-friendly, high impact website to openly share clinical trial information and results, demonstrating leadership in transparency while optimizing trial recruitment and retention.
Veeva Vault Study Startup accelerates time to site activation by connecting global teams and enabling best practices for managing country and site start-up processes. Document-intensive start-up processes and milestone maintenance activities are managed in a single system, providing unparalleled insight and efficiency. And because Veeva Vault Study Startup works with Veeva Vault eTMF within the Veeva Vault Clinical Suite, study start-up and TMF content and data are seamlessly accessed across teams, systems, and studies.
Successful studies begin with the right design. East is the industry standard for designing adequate and well-controlled clinical trials as per FDA and EMA guidance. Since its introduction in 1994, East has reliably and continuously enabled drug and medical device trial sponsors of all sizes to optimize their trial planning and monitoring efforts.
While regulatory compliance is a major driver for serialization projects, breaches to the Pharmaceutical Supply Chain distribution system are also a concern, as they can pose health risks to patients and financial risks to the supply chain stakeholders. At Bellwyck, our holistic and comprehensive approach to serialization ensures these risks will be mitigated and will maximize your value.
Cytel has a strong track record in providing CDISC solutions and we are a CDISC Registered Solutions Provider. We have converted more than 150 studies as part of NDA submissions, all of which have been accepted by the FDA. The Clinical Data Interchange Standards Consortium (CDISC) devised the SDTM and ADaM models to standardize data structures for submission of raw and analysis data from clinical trials. These standard formats are increasingly expected by regulatory authorities including the FDA.
Cytel data scientists apply advanced statistical techniques including predictive modeling of biological processes and drug interactions to unlock the potential of big data. Our team supports biomarker discovery and diagnostic test development based on biomedical signals and images, and real world evidence analysis.
DIA NOW enables on-demand, curated access to actionable insights across DIA's global platforms.
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