Cold-chain logistics expertise
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.
Contracting an in-country clinical depot helps bring costs and timelines under control.
Veeva Vault Study Startup speeds clinical trials by bringing together study start-up activities and processes in a single, easy-to-use application. Part of a unified suite of clinical operations applications, Vault Study Startup enables seamless sharing of information and documents across CTMS, eTMF, and study start-up processes, improving collaboration and increasing efficiency.
Oracle Health Sciences ClearTrial Plan and Source Cloud Service helps you plan, forecast, and outsource clinical projects quickly and accurately—saving you time and money.
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.
CRO manages multiple, complex statistical analysis deliverables for a program of studies, CDISC compliant outputs, and data pooling for NDA submission to the FDA with minimal sponsor oversight.
Sponsors require an end-to-end service that can provide comparators on a global scale. We understand that this requires a full supply chain solution to manage a clinical trial.
Executing efficient and compliant adaptive trials,
Today, more than half of clinical studies take longer than expected to achieve their enrollment targets, often leading to discontinued trials, and expensive failures. EnForeSys is a user-friendly decision tool that leverages cutting-edge simulation methods to predict recruitment milestones with high accuracy. Armed with a reliable probability of success, you can rest assured that your trial will achieve its target enrollment on time and on budget.
Your own dedicated project management team
For more than 25 years, Bellwyck has been a true partner in developing smarter solutions for the pharmaceutical industry — from clinical trial to commercialization. Our consulting services start with a dedicated project management team led by a single point of contact throughout your project.
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