Tata Consultancy Services whitepaper

The Clinical Trial Supplies Control Tower: Gain End to End Visibility for your Clinical Supplies

Clinical trials are getting more global, complex, larger and focused, with CROs facing added pressure to complete them faster. Dynamic market changes demonstrate a need for more collaborative IT solutions that can address new risks across the clinical trials supply chain. The control tower can be leveraged to make these clinical supply chains more responsive, beyond time zone, geography and …

Conducting a clinical safety review in drug development: the regulatory environment

Regulatory bodies have increased the pressure on pharmaceutical companies to measure and monitor the risk of cognitive adverse events associated with investigational treatments. At the same time, companies are becoming aware that monitoring the cognitive properties of investigational drugs can help minimize the risk of late stage failure in drug differentiation. The early stages of drug development programmes aim to …

Enhancing the use of MedDRA in an intelligent online adverse event reporting portal

The process of drug development requires close monitoring of medical events experienced by patients both during clinical trials and post-marketing. Without this critical safeguard, patient safety is put at risk, as well as jeopardizing company¬†reputation, loss of revenue and fall in share price if a product is subsequently withdrawn. Such diligent monitoring relies upon comprehensive reporting together¬†with accurate statistical evaluation. …