info@alphabioresearch.com

Your CRO
in Spain & Portugal

We make your clinical research projects our own

We resolve your needs
in clinical research

Alpha Bioresearch is a full-service CRO that leads international clinical research projects from Spain and Portugal.

We combine the agility and flexibility of a medium-sized CRO with the global coverage associated with large CROs, producing projects quickly, efficiently, and profitably.

Clinical Trials

Observational Studies

Real World Evidence (RWE)

Post Market Surveillance

Research Projects

Statistical Analysis and Biometrics

Medical Writing

Other

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Drugs

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Dietary Supplements

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Medical Devices

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Advanced Therapies

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Dermocosmetics

Global Projects
from Spain and Portugal

Wherever your study needs to be, Alpha Bioresearch has the flexibility and network of local and international contacts to design and implement a strategy that suits your needs.

Digital Solutions

Alpha Bioresearch supports the implementation of digital solutions to carry out your studies.

·eCRF (Electronic Case Report Form)
·ePRO (Electronic Patient-Reported Outcomes)
·Remote monitoring

From Design
to communication

icon Start up / Regulatory
  • Regulatory Strategy
  • Approval procedures with the Competent Authorities
  • Approval procedures with Ethics Committees
  • Identification and selection of sites
  • Methodological advice
  • Documentation: Protocol, Patient Information Sheet / Informed Consent (PIS/IC), Preparation of TMF/ISF
  • Negotiation and signing of contracts
icon Project management
  • Global management and coordination
  • Organisation of research meetings
  • Training of the project team
  • Support for and resolution of incidents
icon Clinical operations and monitoring
  • Management of sites and researchers
  • On-site and/or remote monitoring visits
  • Online patient follow-up
  • Site audits/inspections
  • Preparation of annual monitoring and safety reports (DSURs)
  • Notifications to regulatory bodies
icon Data Science and Biostatistics
  • Data management plan
  • Database generation, validation, and cleansing
  • AEs reconciliation
  • MedDRA coding
  • Sample size calculation
  • Statistical analysis
  • Final statistical report
icon Medical writing
  • Final Clinical Study Report (CSR)
  • Scientific dissemination
  • Protocol drafting
  • Literature review reports
  • Writing of scientific articles
  • Management of publications in national and international journals
  • Writing of expert reports
icon Quality
  • Supplier and site audits
  • Study and documentation audits
  • Support during inspections
  • Risk prevention and management
icon Other
  • Personnel selection
  • PHCP projects
  • Clinical training courses
  • Management of payments to sites and researchers

Associate

Associate

Associate

CRO Partner

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