info@alphabioresearch.com
(+34) 91 745 25 20
As a FULL SERVICE CRO we meet all your needs in the area of clinical investigation and other related fields
We design and develop your investigational project, from early phases to post-commercialization. Our services cover clinical trials as well as observational and epidemiological studies, thereby enabling us to provide guidance at every aspect and each level of your project.
- Design of the project
- Scientific and legal advice
- Establish and maintain contact with research institutions
- Redaction of the protocol
- Design and creation of the CRF
- Marketing material
- Articles and scientific publications
- Abstracts, Posters…
- Statistic advice
- Trainings
Advice and management of the regulatory requirements for clinical trials and investigational projects with medicinal products medical devices in the European Union.
Our Regulatory Affairs Manager’s (RAM) broad experience allows us to provide the optimal strategy for the application at regulatory agencies for each in your project involved countries.
Focused on Startup:
- Essential documentation
- Approval of Competent Authorities (AEMPS, EMA
etc.) - Approval of Ethics Committees (ECs/CEIms)
- Management and negotiation with centers
Our excellence at your disposal for the development of your investigational projects
We manage and monitor your projects providing personnel specialized in the following fields:
- Monitoring (on-site, via telephone and online)
- Risk-based monitoring
- Creation and maintenance of TMFs/TCFs/IFs
- Selection of sites and/or investigators
- Formation of the investigational staff
- Site initiation
- Management of the site
- Management of the investigational product
- Provide project-specific material
Nuestros servicios de Estadísticas y Data management incluyen entre otros la participación en el diseño de protocolo, cálculo del tamaño muestral, diseño del CRD, diseño y creación de la base de datos, planes de data management, plan de análisis estadístico, programación y ejecución del análisis estadístico específico para su estudio, informes estadísticos de resultados: informe intermedio e informe final.
Our tools allow us to work with the highest quality and security standards. All our data management processes comply with European regulations and traceability is ensured using the Audit Trail system.
The consultancy offers you the opportunity and flexibility to adjust your personnel according to the needs and size of your project.
Alpha Bioresearch can provide personnel of all different positions specialized in clinical investigation you might need.