Be viewed as an industry leader while at the same time benefiting from higher quality data and a need for fewer resources with use of an innovative eSource solution.
Submission of PADERs to the FDA is required during post-marketing drug safety surveillance. Instill confidence in your results and regulatory submissions by partnering with an experienced partner.
PV activities will continue to grow in volume and complexity. Trusting an experienced partner to help manage PV requirements can free your team to concentrate on patient efficacy outcomes.
How a CRO is leveraging the eClinical versatility necessary to succeed in a broad array of studies.
In the world of clinical trials and GxP activities, without documented evidence of an event, you cannot confirm what really happened. Learn how one large pharmaceutical customer, at risk of non-compliance to GDP due to a downturn in temperature data, improved their monitor compliance upload rate.
Cellular therapy is a form of treatment where patients are injected with cellular material. Different types of cells can be utilized such as stem cells (such as mesenchymal stem cells) and cells from the immune system (such as regulatory T cells (Tregs)) from either the patient or a donor.
Direction from a solution provider with expertise in forecasting, packaging, labeling and distribution along with services of an IRT provider solves drug shortage challenge.
MSI assay for sensitive detection of 5 mononucleotide repeat markers in tumor FFPE specimens.
Gene expression and analysis for detection of 11 Immune Landscape Signatures.
By eliminating paper source documents from their daily site operations, the clinical research facility has enhanced data sharing, reduced administrative headaches, and ensured, for their clients, high-quality data that meet ALCOA and other attributes as described by regulatory authorities and GCP.
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