3B Biotech Research

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About Us


3B Biotech Research is a Swiss-based International CRO, spin-off of GB Pharma Services & Consulting, an Italian well structured CRO with more than 15 years of experience. 3B Biotech Research can offer a structured team in Switzerland, Italy and Spain and a consolidated network covering France, UK, AT, DE, NL, BE, Nordics, Baltic states, Eastern Europe and USA. 3B Biotech Research can offer the following services in all countries mentioned above:

  • Interventional Trials (Phase II- IV)
  • NIS (registry, PASS, epidemiologic, observational, PRO)
  • Clinical Research services (from protocol writing to e-CRF data management, stats and Clinical Report)
  • Medical Writing
  • Regulatory Affairs
  • Pharmacovigilance pre and post marketing
  • Toxicology

International Activities

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3B Biotech Research is part of a network of CROs which allow to cover international trials.

All Partners, mid size full service CROs, have been audited considering “Evaluational and Qualification” process.

Clinical Trials / NIS

3B Biotech Research is a full service partner that can provide support for all stages of clinical development:

  • Toxicology and PRE-Clinical Studies
  • Phase I and BE/BA Studies
  • Interventional studies Phase I-IV
  • Non Interventional Studies (NIS): Observational Registry (OBS), Epidemiological (EPI), Outcome Research (OR) and Market Access Projects
  • Regulatory Studies (PASS, PAES)
  • Project Management & Monitoring
  • e-CRF / Data Management & Statistics
  • Pharmacovigilance in Clinical Trials
  • Medical Writing (Study Reports)
  • QA, GCP & GVP Audit
  • Vendor selection and audit (GMP, GLP)




Services:

  • Study Feasibility and Centers Selection
  • Study planning and documents preparation
  • Regulatory and Ethic Submissions
  • Clinical Monitoring
  • Safety Management
  • Data Management, eCRF development,validation and management
  • Statistical Analysis
  • Medical Writing
  • QA (including Audit) and Trainings on clinical research activities
  • dor selection, certification and management

PHASE I BIOEQUIVALENCE BIOAVABILITY

The deep knowledge of Phase I studies allow us to timely provide comprehensive quotations of studies/projects performed.

  • Single ascending dose tolerability & pharmacokinetics (First in man)
  • Multiple dose tolerability & pharmacokinetics
  • Local tolerability & sensitisation potential
  • Photo-toxicity and photo-sensitisation
  • Evaluation of gastro-intestinal tolerability of drugs by gastroscopy and by measuring sugars permeability
  • QTc prolongation studies
  • Drug-interaction studies
  • Single / Multiple dose pharmacokinetics
  • Bioavailability
  • Bioequivalence




Thanks to our expertise in clinical pharmacology, and in clinical studies successfully performed, 3B Biotech is able to provide an overall evaluation of projects development.

Through a qualified vendor 3B Biotech is able to perform:

  • Toxicity and mutagenicity studies
  • Research of bacterial endotoxins with qualitative and quantitative methods (LAL)
  • Biological assays in general