The main market opportunities include training on modern technologies for computer system validation, compliance with evolving FDA regulations, and risk-based approaches to validation using CSA and ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

As drug development becomes more complex, so do the demands for accurate, reproducible bioanalytical data to prove their safety and efficacy. Method validation ensures the reliability of ...

By utilizing a standardized methodology for evaluating novel digital measures, sDHT developers, biostatisticians and clinical researchers will be able to navigate the complex validation landscape more ...

Abstract: In the process of digital development of complex equipment, SysML (Systems Modeling Language) has become a key tool in model-based systems engineering (MBSE). SysML provides powerful ...

Objectives To develop and validate educational clinical vignettes (CVs) based on real-life patients with serious pathology from the disciplines of oncology, internal medicine and orthopaedics that are ...

Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...

Regulatory authorities emphasize integrated control strategies, but CAR-T specification setting requires balancing data rigor with regulatory flexibility.

Accurately tracking atmospheric greenhouse gases requires not only fast predictions but also reliable estimates of ...

Months after announcing a new program to validate self-reported nursing home quality data, the Centers for Medicare & Medicaid Services has begun notifying providers of their selection.

High-resolution analytical platforms, proteomics-driven workflows, and expanding CRO outsourcing reshape strategic priorities ...