ARO - University research organization

GINYS-VHIR-009
Olga Sánchez-Maroto Carrizo
Cap de la Unitat

Planta 13. Àrea Materno Infantil HUVH
Passeig de la Vall d’Hebron, 119-129
08035 Barcelona

The Vall D'Hebron Research Institute created in 2014 the University Research Organization (ARO) platform with the aim of helping researchers and sponsors to develop clinical research in Vall of Hebron. The ARO platform offers a complete package on how to manage, from start to finish, the services that are needed to conduct clinical trials and studies. Thanks to its multidisciplinary team, this service can work as a complete contract research organization (CRO) service in clinical trials from phase I to IV within a wide range of possibilities. It also provides advice to the set of researchers and trial sponsors on how to achieve the best experimental design and organizational options to maximize resources. With the collaboration of other VHIR services, the ARO also participates in other aspects that help the development of research projects.

Services

Start-up activities:

  • Guidance, analysis and development of research projects.
  • Analysis and development of documentation for the project.
  • Obtaining the EudraCT number.
  • Approval of the management of the part of the ethics committees and regulatory bodies.
  • Support regarding contract management.
  • Documentation management (general study archive and researcher archive).
  • Public record of the clinical trialss
  • Supplier management (insurance, printer, etc.).
  • List of random distribution.

Project execution activities:

  • Project management and control of project progress.
  • Control of activities (initiation, follow-up and telephone visits).
  • Documentation management.
  • Management of the approval of modifications by the ethics committees and regulatory bodies.
  • Pharmacovigilance.
  • Preparation and direction of the meetings and teleconferences of the researcher.
  • Maintenance of the public record of the clinical trial.
  • Drug management.
  • Management of study materials.
  • Management of study samples.
  • Data management.
  • Statistical analysis plan.

Completion activities

  • Data management.
  • Data entry.
  • Control of activities (completion visits).
  • Statistical reports.
  • Clinical report.
  • Preparation and direction of researchers’ meetings and teleconferences.
  • Maintenance of the public record of the clinical trial.
  • Drug management.
  • Management of study materials.
  • Management of study samples.

Staff

Olga Sánchez-Maroto Carrizo | olga.sanchezmaroto@vhir.org | 671 105 528 ext29747

INSTITUTE

VHIR - Vall d'Hebron Institut de Recerca

Vall d’Hebron Barcelona Hospital Campus
Edifici de l’antiga Escola d’Infermeria,
Passeig de la Vall d’Hebron, 119-129, planta 3

08035 Barcelona https://vhir.vallhebron.com/ca

DOMAINS RIS3CAT

  • Education and knowledge generation system
  • Industrial system
  • Socio-sanitary system

CATEGORIES

  • CLINICAL TRIALS

RATES AND ACCESS

Availability Level: Low
Access Procedures:

Open

QUALITY CONTROL

ISO 9001 – Quality Management
ISO 9001 sets out the criteria for a quality management system. This standard is based on a number of quality management principles that include a strong customer focus, motivation and involvement of senior management, process focus, and continuous improvement. The use of the ISO 9001 standard helps to ensure that customers receive consistent and good quality products and services, which in turn brings many business benefits.
Status: Active

FACILITIES NETWORKS

SCREN – Clinical Research Units and Clinical Trials
SCReN: Support for multicenter clinical trials Achieve an advanced level of technical competence in the processes related to the development and management of clinical research, ensure compliance with legal requirements and the competence of researchers participating in platform studies on methodological aspects and PCBs. others.
Reach: Spain
Status: Active
CERCA - Ginys