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.
VHIO’s Academic Contract Research Organization (VHIO – aCRO), has extensive experience in conducting sponsored trials and investigator-initiated trials (IITs). We offer the complete range 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 investigators and sponsors on how to achieve the best experimental design and offer logistical advice to help them maximize their resources. With a team of 11 professionals, our Unit provides medical writing support, full regulatory activities, monitoring, project management, e-CRF creation, statistics, drug management, insurance management, and pharmacovigilance activities.
In 2022 we have incorporated a clinical trial assistant, and we aim to expand our Unit’s structure with a CRA to be able 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 further strengthen our Facility.
We have also organized our Unit to start working under the new clinical trial regulation (Regulation EU 536/2014), that came into force in January 2022.
- 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 2022, we have successfully managed several major projects including TOPIC, IRONMAN, MONEO, DUREC, BRCA-P, CA209-7J3, MoTriColor, BoB, RAMPART, NIPU among others. Of particular note, two clinical trials in cell therapy with TILs and NKs initiated in 2021 are currently logistically managed by our Unit. Most of these studies are led by our Medical Oncologists and Clinical Investigators at HUVH’s Medical Oncology Department, headed by VHIO’s Director Josep Tabernero.
- During 2022, we successfully met the regulatory requirements for all of our trials (first submissions and amendments).
- Our CRA team monitored more than 160 patients in different hospitals across Spain.
- We managed clinical trial drug requirements in more than 30 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.
