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.

Drug Development

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
• Drug safety
• IoT and connected digital heath platforms

Document Writing

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)
• Research platform
• Risk Management Plan (RMP)

Safety Assessment

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
• Drug-drug interactions
• Product contamination assessment/ report