NOVA-CRU Team has expertise in the core competencies required for design and conduct of high quality trials, including several services: protocol development, trial submission, trial management, data collection (eCRFs), data processing, data management and biostatistics.
 
NOVA-CRU developed a crucial partnership with NOVA Information and Management School (NOVA IMS) (http://www.novaims.unl.pt) aiming to broaden the scope of offered high quality services to e-CRF development, data management, data cleaning and data analysis, and also biostatistics.

NOVA-CRU is located at the recently 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.
NOVA-CRU is part of NOVA Medical School (NMS|FCM) Medicine Faculty, a Public institution of Universidade NOVA de Lisboa’s (NOVA) since 1977, NMS|FCM has a significant number of groups of excellence in biomedicine, translational research, clinical research, and epidemiology and services and offers a great diversity of postgraduate courses and programmes in different health areas.

Study 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

. Authorities submissions across Portugal (CEIC, CNPD, INFARMED) and internationally

. Sites approval process

. Authorizations follow-up

. Submission of amendments, progress and safety reports

 

CRF 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 

. Anonymization 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 pulls 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 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

 

Database build 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