The academic Contract Research Organization (CRO) has extensive experience conducting sponsored trials and investigator-initiated trials. The CRO offers a complete package of start-to-end management services needed to perform clinical trials and studies. Due to its multidisciplinary team, the unit can work as a full service CRO in clinical studies from Phase I to IV. It also offers advice to all researchers and sponsors of studies on how to achieve the best experimental design and logistic options in order to maximize their resources. With a team of 6 professionals, the CRO offers medical writing, full regulatory activities, monitoring, project management, e-CRF creation, statistics, drug management, insurance management and pharmacovigilance activities.
- Clinical project management support to awarded R&D projects (European/Pharma funded) academic Oncology Clinical Trials leaded by Vall d’Hebron oncologists team.
- Academic CRO for Investigator initiated trials
- In 2019 our academic CRO successfully managed a number of large projects: COMBAT, TOPIC, IRONMAN, MONEO, among others. Most of them are leaded by the Valle d’Hebron oncologist team.
- During this period, we were able to succeed with all the regulatory requirement of all of our trials (first submissions and amendments).
- Our CRA team were able to monitor more than 150 patients in several hospitals in Spain.
- Our team managed clinical trials drug requirements in more than 25 hospital in Spain
- In 2019 our activity generated enough benefits to be able to cover CRO activities for non-funded academic trial.
- Expand the unit structure with a clinical project manager and a CRA to be able to manage the current and the future clinical trials.
- Optimization of the CRO digital tools to allow remote work.
- Brings out the best in each team member to support this new created core facility.
CRS Unit Head: Susana Muñoz. Lead CRA and Project Manager: Marta González. Clinical Research Associate: Darío López, Júlia Molina, Lídia Piquet, Irene de la Torre
Biosketch Susana Muñoz
Head of the Academic CRO.
- Diploma del Programa Abierto de Especialización en Project Management en Investigación Clínica (CESIF), 2019
- Diploma of Advanced Studies (Grade: Excellent). Germans Trias i Pujol University Hospital. Topic: Guidelines for Clinical Research in Residency.
- 1998-1999. Master in Environmental Impact Analysis and Assessment (Grade: Excellent). Centro de estudios I.U.S.C.
- CAP (Training program for Secondary and Upper Secondary Education in Science [teachers training program]). Universitat Autònoma de Barcelona.
- 1993-1997. Master’s Degree in Biology and Zoology (Grade: Notable [~ C grade]). Universitat Autònoma de Barcelona, Spain.
Areas of Research
- Management in clinical trials.
Most relevant scientific publications
- Canet J et al. Prediction of Postoperative Pulmonary Complications ina Population-based Surgical Cohort.Anesthesiology, 2010. 113 (6).
- Moret E, Flo A, Escudero E, Sariñena M, Massó E, Muñoz S, Canet J.Tranexamic acid, blood loss and transfusion after valve replacement cardiac surgery: a randomized controlled trial of two modes of administration. Transfusion Alternatives in Transfusion Medicine, 2007. 9: 134–142.
- Rasmussen LS, O´Brien JT, Silverstein JH, Johnson TW, Siersma VD, Canet J et al. Is peri-operative cortisol secretion related to post-operative cognition dysfunction? Acta Anaesthesiol Scand 2005; 49: 1225-1231. (Appendix investigator)
- Apfel C, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I et al. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. The New England Journal of Medicine. June 10, 2004. Vol.350 nº 24. (Appendix investigator)
- García-Guasch R, López de Castro PE, Lucas M, Busquets J, Sariñena M, Muñoz S. Experiencia inicial con los bloqueadores bronquiales tipo Arndt en cirugía torácica.
- Revista Española de Anestesiología y Reanimación2005; 52: 19-23
- Espí C, Vila P, Muñoz S, Monerris M, Mazo V, Canet J. Estudio comparativo del índice biespectral y la entropía espectral en cirugía ginecológica.Revista Española de Anestesiología y Reanimación 2005; 52: 315-320
- Sabaté S, Canet J, Muñoz S, Castillo J, Lucas M, Mayoral V. Epidemiología de la anestesia en Cataluña en 2003. Med Clin (Barc). 2006;126 (Supl 2):13-18