Update of the Guide of Research Units in Early Phases (IV Edition)

Update of the Guide of Research Units in Early Phases (IV Edition)

Within the framework of the Innovative Medicines Platform, several Guides to Early Phase Research Units have been developed with the aim of, among other objectives, promoting the conduction of biomedical research. To date, the following Guides have been developed: Guide to Paediatric Clinical Research Units, Guide to Preclinical Screening, and the new update of the Guide to Early Phase Research Units (4 editions).

On this occasion, it has been decided that the operability of the Guide will be improved through the creation of a website which will both facilitate editing of the Guide and future exportation and visualisation of information in order to meet industry needs as regards new designs of clinical trials, the scientific standard, and regulatory requirements.

The current version was made in collaboration with 38 Early Phase Research Units within the BEST Project framework, a project pioneered by the pharmaceutical industry which brings together all public and private stakeholders to create a Platform for Clinical Research Excellence of medicines in Spain

Of the objectives this Guide aims to achieve, the following two are worth highlighting: acting as a stimulus for the conduction of early phase studies (particularly phases I and II) in Spain and acting as a work tool for FARMAINDUSTRIA member companies. This edition of the Guide to Early Phase Research Units was published in 2021 and is intended for widespread dissemination among all organisations interested in or relevant to clinical research.

The information gathered in this Guide was obtained from a questionnaire completed by the 38 Early Phase Research Units over the course of 2020. The guide includes 8 main sections for each unit: (i) overview; (ii) standard, accreditation, auditors and inspections; (iii) innovative facilities and resources; (iv) staff; (v) clinical trial participants; (vi) pharmacodynamic and pharmacokinetic evaluation; (vii) experience and activity; and (viii) metrics.

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The Spanish Technological Platform for Innovative Medicines is supported by financial assistance from the Ministry of Science and Innovation (PTR-2018-001046 and PTR2020-001156).

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