Pharma, life sciences and biotech organizations need to schedule, capture
and control data from clinical trials easily and efficiently.
These organizations leverage a vast range of new technologies such as IoT, Digital, Data and Analytics, Cloud and Applications, which are used for clinical programs in diverse areas like Investigational New Drugs (IND) for multiple small molecules, biologics and cell therapy. The result is the creation of new eco-systems, better program management, and powerful insights designed to deliver meaningful healthcare.
Our capabilities are designed to assist organizations go beyond treatment by addressing research, quality, manufacturing, safety and risk.
Access data and digital technologies that allow life science, pharma and medical devices organizations to streamline research, discovery, development and testing of products through our:
Clinical, contract manufacturing and quality platforms
Data governance, data orchestration and data interpretation
IoT and connected digital heath platforms
Document writing must conform to a variety of regulatory and scientific templates and parameters. Our documentation services are an important part of the process of identifying new products, compounds, molecules and drugs, validating them, establishing safety, taking them to market and improving patient care. These services include:
Clinical Study Reports (CSR)
Periodic Benefit Risk Evaluation Report (PBRER)
Risk Management Plan (RMP)
Safety assessment represents a sensitive and critical part in the development and approval cycle of new healthcare devices and formulations. Our services deliver early signals to minimize risk through:
Aggregate reports (PSUR, RMP, PBRER) across drug classes
Discovery – Dx rescue, lawsuits
Product contamination assessment/ report
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