Legal Affairs and Clinical Trials Contracting Unit

The Legal Affairs and Clinical Trial Contracting Unit provides administrative, technical, and financial advising to both researchers and sponsors regarding the management, negotiation, and conduct of clinical trials on medicines for human use as well as observational studies and clinical research conducted in the different centres of the Andalusian Public Healthcare Service in the province of Málaga.

The Network of Research Management Foundations of the Andalusian Public Healthcare System has developed a guide with the aim of creating a SINGLE, STANDARD PROCEDURE in order to facilitate the conduct of clinical studies in Andalusia (Download the guide ) for Sponsors and CROs for the participation of Andalusia Public Healthcare System health centers in clinical trials.)

Services

  • Processing and management of the suitability of facilities documentation
  • Processing, negotiation, and management of financial agreements for clinical studies
  • Recruitment of sponsors interested in conducting clinical trials
  • Personalised advising for the sponsor on the search for principal investigators and collaborators for the conduct of clinical trials

Contact

Inma Mena Ramírez

Legal Affairs and Clinical Trial Contracting Manager

Contacto: 646 87 07 47

inma.mena@ibima.eu

Rosa María Navarro Bellido

Clinical Trials Administrative Management Technician

Contacto:  951 29 14 45

gcontratos.hrmal.sspa@juntadeandalucia.es

Carlos Rodríguez Rodríguez

Clinical Trials Administrative Management Technician

Contact: 951 29 14 15 | 639 19 98 06

gcontratos.hrmal.sspa@juntadeandalucia.escarlos.rodriguez@ibima.eu

Virginia Vázquez Rodríguez

Clinical Trials Administrative Management Technician

Contacto: 951 29 14 15 | 689 11 10 68

virginia.vazquez@ibima.eu | gcontratos.hrmal.sspa@juntadeandalucia.es

Rosario Alonso Rodríguez

Clinical Trials Administrative Management Technician

Contact: 951 29 14 15 | 660 01 24 83

gcontratos.hrmal.sspa@juntadeandalucia.esrosario.alonso@ibima.eu

 

Margarita Durán Frías

Legal Affairs Technician

Contacto: 628 73 82 33

margarita.duran@ibima.eu

Esperanza Pastor España

Clinical Trials Recruitment Techncian

Contacto: 679 81 43 61 | 676 866

esperanza.pastor@ibima.eu| gcontratos.hrmal.sspa@juntadeandalucia.es

Desirée Martín García

Clinical Trials Administrative Management Technician

Contacto: 679 050 731

desiree.martin@ibima.eu

Download clinical studies documentation

 

 

Los costes de gestión administrativa aplicables en la anualidad 2025 son los siguientes:

  • Gestión de nuevos contratos: 1.343,30.-€ + IVA
  • Gestión de adendas sin cambios en el informe financiero: 335,98.- € + IVA
  • Gestión de adendas con cambios en el informe financiero: 529,93.- € + IVA

Dichos importes serán actualizados de manera anual conforme a la evolución del IPC.

*Puede consultar los criterios de costes por gestión Administrativa derivados de los contratos para la realización de Estudios Clínicos en el SSPA en este enlace.

Drug clinical trials:

Drug clinical trial agreement Spanish

Agreement template

Annex I and Annex II

Annex III

Clinical study with a medical device

Agreement template

Annex I and Annex II

Annex III

Observational Study with Drugs for human use

Observational Study with Medicines for human use in Spanish

Agreement template

Annex I and Annex II

Annex III

Observational Study with Drugs for human use in English

Agreement template

Annex I and Annex II

Annex III

Clinical study with a medical device

Clinical study with a medical device in Spanish

Agreement template

Annex I and Annex II

Annex III

Clinical study with a medical device in English

Agreement template

Annex I and Annex II

Annex III

Agreement addendum

Agreement addendum in Spanish

Agreement addendum

Annex I and Annex II

Agreement addendum in Spanish in English

Agreement addendum

Annex I and Annex II

Suitability of facilities

Exemption from administrative management