NOVA-CRU

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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: This email address is being protected from spambots. You need JavaScript enabled to view it.
Phone:  +351 966 481 004
Website: under development

 

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