CLINICAL RESEARCH UNIT NOVA-CRU

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, PharmaMSc, PhD
E-mail: nelia.gouveia(at)nms.unl.pt
Phone: +351 966 481 004
Website: www.novacru.unl.pt

NOVA-CRU: organization for clinical research
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

SERVICES PROVIDED

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