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.

Global Approach

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)

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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

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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

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Core Lab Services

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

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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.

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