The speed of science is accelerating to address the most significant health concerns facing the world today. At SCHARP, we recognize the importance of data and analytical rigor to provide the insights ...

Data Mapper transforms study metadata into draft SDTM and ADaM specifications, accelerating one of the most time‑consuming steps in clinical reporting. Once specifications are finalized, Data Mapper's ...

This Concept Paper supports a proposal for a new harmonised guideline that specifies comprehensive clinical protocol organization with standardized content with both required and optional components.

Certara, Inc., a global leader in biosimulation, announced the availability of Pinnacle 21 Enterprise Plus. The solution enables clinical and statistical programmers to efficiently create, reuse, and ...

Read how patient-centric care models and pharma innovation are ushering new trends in life sciences to improve patient outcomes and enrich lives. TCS ADD™ is a suite of modern and open technology ...

Continuous medical and safety monitoring of subject data during a clinical trial is a critical part of evaluating the safety of trial participants and as such is governed by protocol procedures and ...

The conect4children (c4c) project aims to facilitate efficient planning and delivery of paediatric clinical trials. One objective of c4c is data standardization and reuse. Interoperability and ...

Pharmaceutical organizations must adhere to a specific set of procedures regarding their clinical trial submissions before sharing data with regulatory agencies. One crucial step in this process is ...

The Clinical Data Interchange Standards Consortium, or CDISC, creates medical research standards for the healthcare and pharmaceutical industry, especially for medical research such as clinical trials ...

The Clinical Data Interchange Standards Consortium (CDISC) is dedicated to the improvement of medical research through data standardization. CDISC has produced a suite of standards that should be used ...