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.
During 2023, we started working with the new Clinical Trials Information System (CTIS), under new clinical trials regulation (Regulation EU 536/2014), that came into force in January 2022. We have successfully submitted two new clinical trials through CTIS.
- 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 2023, we have successfully managed several major projects including IRONMAN, MONEO, DUREC, BRCA-P, BoB, RAMPART, NIPU, among others. Of particular note, two clinical trials in cell therapy with tumor-infiltrating lymphocytes (TILs) and natural killer cells (NKs) initiated in 2021 are currently logistically managed by our team. We are also managing a multicenter French-sponsored study for patients with peripheral T-cell lymphoma (PTCL) in Spain.
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. We have also obtained the approval of a new TIL clinical trial, submitted via the Clinical Trials Information System (CTIS). - During 2023, we successfully met the regulatory requirements for all of our trials (first submissions and amendments). In 2024, we will transition all our active clincial trials from the previous Spanish Agency of Medicines and Medical Devices (AEMPS) platform to CTIS.
- Our clinical research associates monitored more than 150 patients in different hospitals across Spain.
- We managed clinical trial drug requirements in more than 35 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.
