The Academic Contract Research Organization (CRO) has extensive experience conducting sponsored trials and investigator-initiated trials. They offer a complete package of start-to-end management services required to perform clinical trials and studies. Our multidisciplinary team enables us to operate as a full service CRO in clinical studies from phase I to IV.
We also provide guidance to all researchers and sponsors on how to achieve the best experimental design, and offer logistical advice in order to maximize their resources. With a team of 10 professionals, our Unit provides medical writing support, full regulatory activities, monitoring, project management, e-CRF creation, statistics, drug management, insurance management, and pharmacovigilance activities.
We seek to expand our Unit by incorporating a clinical project manager and a clinical trials assistant. This will allow us to even more effectively manage current and future clinical trials, optimize CRO digital tools for working remotely, as well as continue to bring out the best in each team member to enhance VHIO’s aCRO.
- Clinical project management support to awarded R&D projects (European/Pharma funded), academic oncology clinical trials led by our Medical Oncologists and Clinical Investigators at VHIO and the Vall
d’Hebron University Hospital (HUVH), Vall d’Hebron Barcelona Hospital Campus
- Academic CRO for IITs
- Academic CRO for pharmacy sponsored trials where VHIO is involved in the development of the studies
- In 2021, our academic CRO successfully managed a number of major projects including AGI-134.FIM.101, TOPIC, IRONMAN, MONEO, DUREC, BRCA-P, CA209-7J3, MoTriColor, BoB, among others. Most of
these are led by by our Medical Oncologists and Clinical Investigators at Vall d’Hebron’s Medical Oncology Department, headed by Josep Tabernero, VHIO’s Director.
- Of particular note, two clinical trials in cell therapy with TILs and NKs initiated this year. These studies are logistically managed by our Unit.
- During 2021, we successfully met the regulatory requirements for all our trials (first submissions and amendments).
- Our CRA team monitored more than 150 patients in different hospitals across Spain.
- We managed clinical trial drug requirements in more than 25 national hospitals.
- We have also demonstrated sufficient benefits that support CRO activities for non-funded academic trials.
- 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.