Oncology

By working closely with a network of specialized researchers and clinicians, Biotrial offers a customized approach to Oncology development. Our dedicated team of experts work together to provide guidance from Non-clinical, in-vitro & in vivo, to Early Phase patient studies by building packaged services tailored to sponsor’s needs.

 

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Translational expertise in Oncology

Preclinical Services

  • GLP regulatory/early safety derisking (Core Battery)
  • Safety Pharmacology Studies:
    Follow-up and Supplemental Studies (cardiac output, ventricular contractility, vascular resistances, troponin)
  • Validated models for efficacy evaluation in Cardiovascular pathophysiological models of Arrhythmias, Heart Failure, Thrombosis (Telemetry)

Clinical Services

Extensive early development expertise in Phase I and II worldwide:

  • Medical expertise & Scientific advice
  • Study feasibility assessment
  • Site selection / qualification
  • Site contracting & payment support
  • Clinical trial management
  • Regulatory services
  • Pharmacovigilance services
  • Clinical monitoring
  • Medical monitoring
  • Central lab services
  • Supply management

Biometrics

  • Adaptive Escalation Designs (CRM, BLRM)
  • EDC solutions including Central Randomization and Clinical Supply
  • Streamlined PV reporting
  • Support for Interim, Futility and DSMB analyses as well as final trial analysis

Core Lab Services

Central Imaging management 
(RECIST, Rano, Cheson, Lugano)

Bioanalytical Services

Biotrial’s Bioanalysis experts are specialized in oncology and immuno-oncology drugs, cytotoxic drugs, and molecularly targeted agents. Our scientists have decades of experience supporting oncology research and regularly develop challenging assays.

Areas of Expertise

  • Stem cell therapy
  • Targeted therapy (small molecules and biologics)
  • Chemotherapy
  • Radiation therapy
  • Hormone therapy
  • Immunotherapy (checkpoint inhibitors, MABs, T-cell therapy)
  • Medical devices
  • Cancer supportive care medication (analgesia, anemia, emesis, cachexia)
Biotrial Therapeutic Area Oncology Expert Scaled

Oncology Expertise

  • Access to prominent KOLs and specialized sites and networks
  • In-house Oncologists
  • Global regulatory & PV expertise
  • Patient centric approach (ePRO, home nursing…)
  • Team of trained professionals experienced in latest oncology designs & endpoints
  • Non-clinical and Clinical operational expertise
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Indications

  •  Solid tumors
  •  Hematological malignancies

Added Value / Advantages

  • Translational approach from Non-Clinical to Clinical development.
  • Full-service oncology solutions.
  • Flexible Process and Solutions.
  • Experience in safety and toxicity reporting.
  • Expertise in complex study designs and novel endpoints.
  • Oncologists and Hematologists medical network in Europe and in the US.
  • Feasibility and site selection.
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