Clinical research unit of NOVA [NI-SERV-2020-01]
NOVA-CRU intends to foster the execution of independent clinical studies, in accordance with good clinical practice, promoting the creation of an infrastructure to support researchers in conducting clinical studies, thus contributing to the generation of relevant evidence and impact on clinical practice.
OPPORTUNITY TO BE PROMOTED
Service Provision / Expertise
OVERVIEW
NOVA-CRU is the clinical research management unit of Universidade NOVA. It is a joint venture between NOVA Medical School and NOVA Information Management School.
NOVA CRU has four main core business activities:
1. Management of Clinical Research:
Includes the following activities: Start-up Phase: Submission to the Authorities; Implementation and Monitoring; Clinical studies Management.
NOVA CRU collaborates with more than 8 international Academic Institutions.
At a national level, NOVA CRU’s activity thus far involves the management of more than 30 research teams dispersed by more than 20 hospitals not only in the Mainland, but also in the Azores and Madeira.
Clinical trials cover different clinical areas: Neurology, Rheumatology, Rehabilitation, Internal Medicine, Intensive Care, Oncology, Cardiology, among others.
2. Coordination in Health Care Units
NOVA CRU is supporting the Clinical Research Department of Centro Hospitalar Lisboa Ocidental, since November of 2015.
NOVA CRU stratagy aimed to implemente this core business activity in other Health Care Units in Portugal.
Coordination in Health Care Units comprises the support for clinical resarch teams providing tasks in which the intervention of the Study Coordinator is legally and ethically acceptable, namely:
- Assist in identifying potential participants
- Organize the participants visits
- Organize the internal logistics associated with clinical studies
- Complete administrative forms and case report forms (CRFs), which do not necessarily have to be filled out by other members of the research team.
- Organize and maintain the Investigator Site File (ISF).
- ‘Contact person’ for the monitors and auditors of the Sponsors including their receipt and follow-up during monitoring and audit visits.
- Keep the updated record of the acts to be invoiced to the sponsors
- Preparation of audits by external Sponsors and inspections by Regulatory Authorities, and implementation of possible corrective and preventive measures.
3. Data management & Data Analysis
Comprises the following activities:
- Electronic Case Report Forms development
- Development of Statistic Plan
- Development and exportation of master database
- Data cleaning
- Analysis of the results
- Interpretation of results
- Medical writting regarding data analysis
4. Training
- Short term:
In 2018 NOVA CRU provided a complete training program directed to the Research Teams of the whole country, in order to train them and increase their performance, promoting and boosting their degree of competitiveness.In this way, NOVA CRU’s training plan is organized into two main themes – Research in clinical practice and Study Coordination – that integrate each of them, a set of short- or medium-term training actions. - Long Term:
In September of 2018 placed the first edition of the Master in Clinical Research Management (MEGIC).
This cycle of studies aims to train highly qualified human resources to professionalize clinical research in healthcare units, universities, biobanks, pharmaceutical companies, health technology companies which collaborate in clinical research.
MEGIC is a collaboration of Universidade NOVA (NOVA Medical School, NOVA Information Management School, and Escola Nacional de Saúde Pública) and Universidade de Aveiro.
COMPETITIVE ADVANTAGES
With expertise in areas such as the development of clinical research protocols, submission of clinical trials to the authorities, monitoring and management, data analysis, construction of electronic case report forms, NOVA-CRU counts with a set of capabilities and experience, which puts at the service of the academic, medical and pharmaceutical community.
NOVA CRU work together with all hospitals in Portugal (mainland, and Azores and Madeira Islands), as well with clinical teams based on clinical research centers outside NOVA.
NOVA CRU offers a complete pack of activities that can be adjusted to clinical research teams’ needs.
APPLICATIONS
NOVA CRU collaborates with more than 8 international Academic Institutions.
At a national level, NOVA CRU’s activity thus far involves the management of more than 30 research teams dispersed by more than 20 hospitals not only in the Mainland, but also in the Azores and Madeira.
Clinical trials cover different clinical areas: Neurology, Rheumatology, Rehabilitation, Internal Medicine, Intensive Care, Oncology, Cardiology, among others.
FURTHER DETAILS
RESEARCH UNIT
NOVA Clinical Research Unit.
