NOVA Clinical Research Unit (NOVA-CRU) is a joint venture between NOVA Medical School (NMS) and NOVA Information and Management School (IMS) and is the preferential point-of-contact for planning and set up of clinical trials. 

As a Clinical Trial Unit (CTU), NOVA-CRU is available to provide support to academic led trials and Industry-Sponsored Clinical Trials, according to International Council for Harmonisation-Good Clinical Practice Guidelines (ICH-GCP).

Contact person: Nélia Gouveia, PharmMSc, PhD
Email: nelia.gouveia@nms.unl.pt
Phone:  +351 966 481 004
Website: under development

 


NOVA-CRU Team has expertise in the core competencies required for design and conduct of high quality trials, including: protocol development, trial submission and regulatory, trial management, data collection (eCRFs), data processing, data management, and biostatistics.

NOVA-CRU is currently accompanying phase I, phase II and III Clinical Studies, both within national and international academic sponsors.

Core competencies:
- Trial design
- Multi-site trial management
- Database provision and data management
- Biostatistics and data analysis
NOVA-CRU is located at the NMS|FCM campus – Research Pole, enabling close interactions with the research groups and network of CEDOC (Chronic Diseases Research Center) and state of the art research laboratories.

 
Study protocol development 
To ensure that studies are designed, analyzed and reported according to the goals and according to ICH-GCP:
. Develop the design for a clinical trial, including assistance the preparation of the study protocol 
. Advice on protocol design and outcome measures
. Budget estimation
. Grant design proposal

Gaining ethical and regulatory authorities 
To provide complete processes according to national and international ethic and legal regulatory 
. Authorities submissions across Portugal (CEIC, CNPD, INFARMED) and internationally
. Sites approval process
. Authorizations follow-up
. Submission of amendments, progress and safety reports 

Case Report Forms (CRFs) design 
To capture good quality, valid, auditable and contemporaneous data:
. Assistance with the design of electronic Case Report Forms (e-CRF)
. Electronic data capture (eCRF) design
. CRF validation
. CRF review 
. Data collection
. Anonymisation of trial datasets
. Web randomization service 
. Data query reporting for missing or invalid data
. Management of study closedown and database lock phase

Clinical Trial management 
To pull all critical elements of a clinical trial together to ensure its successful delivery on time, within budget and to a high standard:
. Collection of feasibility data and development of pilot studies
. Management plan design and execution (timelines and projections)
. Clinical trial coordination, including sample management, with storage requirements 
. Research Team support, training meetings and maintain schedule participant visits and follow-up, ensuring high quality of data collection 
. Maintain study site files in accordance with GCP requirements 
. GCP advice
. Strategies for patient recruitment 
. Regulatory support
. Safety reporting
. Financial and resources management
. Review or writing of the clinical study report
. Assistance with the site training
. Clinical trial monitoring

Biostatistics and Data analysis 
To develop methods to improve the quality and reliability of data:
. Sample design
. Sample size calculations
. Advise on randomization methods   
. Writing or review of statistical analysis plan
. Provision advice and support for statistical analysis
. Provision central statistical monitoring 
. Contribution to production of reports to funders
. Medical writing 

Database design and data management 
To provide a range of data management services and to enable the creation of systems that provide a successful infrastructure for clinical trials 
. Database design, development and validation
. Web-based data entry systems
. Central data entry 
. Data query management
. Provision of cleaned and locked datasets
. Archiving of databases
. Data cleaning
. Data analysis – interim and final results