Strategies for the fulfillment of regulatory needs and quality assurance in the areas of R&D
The total management of the daily needs identified in the area of R&D, and mainly in clinical/biomedical research, requires qualified specialists and with demonstrated level of experience in this sector.
Biomedical research (Spanish Biomedical Research Law 14/2007) and clinical research (ICH E6 R1 y R2, GCP)
Design, implementation and maintenance of Quality Systems in biomedical/clinical research, as:
- Gap analysis.
- SOPs.
- Metrics.
Consultancy in:
- GCP (Good Clinical Practices).
- GCDMP (Good Clinical Data Management Practices).
- GCLP (Good Clinical Laboratory Practices).
- Data Integrity and clinical databases (CDISC).
GCP audits to:
- CROs.
- Medical departments.
- Sites/investigators.
- Central labs.
- Clinical trial (global or specific activities).
- Mock inspections.
Technical/specialized audits to:
- eCRF.
- eTMF.
- Data Management/GCDMP.
- Computerized systems validation (compliance with 21 CFR part 11, Annex 11 GMP).
Risk analysis in clinical research
Consultancy services in GLP / GCLP / ISO 15189 for clinical laboratories
- Strategy of accreditation.
- Design, implementation and maintenance of Quality Systems.
- Gap analysis.
Phase I units
- Strategy of accreditation and compliance with applicable technical health requirements.
- Risks analysis and management.
- Audits.
- Quality Systems.
CDISC Standards
Consultancy services and implementation of:
- CDASH.
- SDTM.
