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.

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