ЛЕКАРСТВЕННЫЕ СРЕДСТВА ДЛЯ МЕДИЦИНСКОГО ПРИМЕНЕНИЯ

МЕТОДЫ И СРЕДСТВА ОБЕСПЕЧЕНИЯ БЕЗОПАСНОСТИ

КЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯ МЕДИЦИНСКИХ ИЗДЕЛИЙ, ПРОВОДИМЫЕ С УЧАСТИЕМ ЧЕЛОВЕКА В КАЧЕСТВЕ СУБЪЕКТА

НАДЛЕЖАЩАЯ КЛИНИЧЕСКАЯ ПРАКТИКА

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

The International Council for Harmonisation (ICH) is committed to developing timely technical requirements for pharmaceuticals for human use in a manner that is responsive to the needs of the global community.

This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations

The efficacy and safety of medicinal products should be demonstrated by clinical trials which follow the guidance in 'Good Clinical Practice: Consolidated Guideline' (ICH E6) adopted by the ICH, 1 May 1996.

To properly inform decision making by pharmaceutical companies, regulators, patients, physicians and other stakeholders, clear descriptions of the benefits and risks of a treatment (medicine) for a given medical condition should be made available.

The objective of this guideline is to allow the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions

In order to facilitate the implementation of the E3 Guideline, the ICH Experts have developed a series of Q&As

We are a global community and platform for the discussion of topics encompassing the work of data managers, biostatisticians, statistical programmers, data scientists and eClinical IT professionals.

Medical dictionary for regulatory activities

we develop the science of pharmacovigilance and support initiatives to ensure the safety of medicines and patients around the world.

СПРАВОЧНИК ЛЕКАРСТВЕННЫХ СРЕДСТВ

Pinnacle 21 offers a broad suite of solutions for your data needs: speccing, mapping, cleaning, checking, comparing, transforming, converting.

With our open, cloud-native AI, analytics and data management platform you can discover insights from your data and make sense of it all.

R is a free software environment for statistical computing and graphics. It compiles and runs on a wide variety of UNIX platforms, Windows and Mac OS.