- PROJECT MANAGEMENT AND START-UP
- REGULATORY AFFAIRS
- MATERIAL AND MEDICATION MANAGEMENT AND IMPORT
- START-UP, MONITORING AND CLOSURE
- STATISTICAL REPORTS
- FINAL REPORTS
- STORAGE OF CLINICAL DOCUMENTATION AND MATERIALS
- EVENTS ORGANIZATION
CUSTOMIZED TO THE PROJECT.
WITH OTHER CROs
PHARMACEUTICAL SERVICES ORGANIZATION
CABYC is a CRO that provide complete services in any Clinical Research Project at any stage of the Clinical Development and with extensive experience in Multinational Studies.
Urology / Nephrology
- Project Management. Monitoring and Clinical Research activities at any stage of the Clinical Development.
- Outsourcing of CRAs.
- Regulatory Affairs.
- Events organization.
- Scientific translations.
- Personnel Search and Selection.
- Biotechnological and clinical projects realization.
- Storage of Regulatory or Clinical Documents.
CABYC guarantees the confidentiality of documents and data previously received as well as the results obtained during the development of the work, by the signature of a Confidentiality Agreement.
- Pre-Clinical Studies.
- Bioequivalence Studies.
- Clinical Trials (phases I, II & III).
- Post marketing Trials (phase IV (PAS) or Observational).
- Biotech Projects.
- BOLTON CILE
- Bristol Myers Squibb
- FAES FARMA
- Fondaciones Salvatore Maugeri
- Genzyme (Ahora Sanofy)
- Hanita Lenses
- Instituto del Sueño
- MTA (Medical Trials Analysis)
- Novo nordisk
- Pierre Fabre
- Praxis Pharma
- Schering-Plough (ahora fusionadacon Merck)
- Serono (Ahora Merck-Serono)
- Investigators and Sites Selection, Feasibility Questionnaires
- Preparation, submission & follow up of Documents to IECs/IRBs and AEMPS (Spanish Health Authorities)
- Contracts Management for Hospitals, Foundations and Investigators as well as Insurance Policies
- Coordination & Organization of Investigators Meetings
- Clinical Trials Monitoring according to GCPs and/or Sponsor’s SOPs (Selection, Start-up, Monitoring and Closure visits)
- Periodical reports (as agreed) to the Sponsor, IECs and AEMPS. Teleconferences
- Data Management
- Biostatistics Analysis
- Final report elaboration
- Collection and Report of Serious Adverse Events (SAEs) in a timely manner to IECs/IRBs, Investigators & HA
- Follow up of SAEs
- Reports to Sponsor and/or Institutions involved
- Organization and maintenance of archives per site and for all docs generated during the CT
- Storage and retrieval of archives after the study termination during 5, 15 or 30 years, according to the Law
- Retrieval, delivery, collection and archiving of documents for Audits
- Management and elaboration of the Regulatory Dossier from the beginning to the end of the process, including all the necessary tasks to obtain the product registration.
- CABYC has developed its first IT tool for collect and electronically management on real time of data during all the development of any Clinical Trial.
- CABYC’s e-CRF combines the experience achieved through many years conducting clinical trials with the most advanced IT technology in this area.
- Easy handling, intuitive and really practical, in real-time, for both the investigator as well as supervisor.
CABYC is partner of a Biotech European group to develop Gene Therapy Platforms.
Great progresses have been achieved in most of Auto-immune diseases, Allergies and also in many Rare Diseases.
Important developments in Oncology through CARs.
Through the international partnership with a multidisciplinary scientific group, CABYC is working to provide anti-infectious platforms in a very short period of time manufacturing peptides on request.
A novel methodology capable of obtaining the protein structure needed to synthesize a peptide on request has been developed.
Anticancer engine based on electromagnetic waves
Av. Somosierra, 12.
Portal Izquierdo. 2.o G
San Sebastián de los Reyes
Whether you want to know in detail any of our services or products do not hesitate to contact us.
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