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SciQuus Oncology

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La Jolla, California, US

About SciQuus Oncology

SciQuus Oncology is an oncology-focused clinical research organization committed to the advancement of your clinical research program.

We take pride in the level of oncology and program management expertise that we can offer to the biopharmaceutical and clinical research communities.

SciQuus offers a broad range of services to the pharmaceutical and biotechnology industries. Our experience spans the development lifecycle from preclinical studies required for an IND to the management of large registration trials.

Our Services (28)

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Project Management

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Pharmacovigilance and Post-Authorization Safety Studies (PASS)

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Product Development Consulting

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Drug Development Consulting

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Medical Affairs

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Medical Writing

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PK/PD Data Analysis

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Data Management

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  • Database design/programming and testing utilizing various electronic data capture systems
  • Adherence to CDISC, SDTM, and CDASH standards
  • Randomization management

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Regulatory Affairs Consulting

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Clinical Trial Site Selection

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Clinical Trial Management

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Clinical Development Strategy

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  • Clinical development plans
  • Protocol design, feasibility, and generation
  • Site selection, feasibility, qualification, and start-up activities
  • Complete management of phase I-III trials
  • Medical monitoring and safety services
  • Medical management (e.g., PI meetings, DSMBs, end of cohort Safety Meetings)
  • Clinical trial simulations (SimQuus™)
  • Regulatory applications and submissions

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IND/NDA/BLA Submission

Investigational New Drug/New Drug Application Submission
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Preclinical Study Design

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Animal Models and Studies

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Computational Modeling

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Pharmacology & Toxicology

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Epidemiology, Healthcare, and Post-Authorization Studies

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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Clinical Trials, Consulting, and Management

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Regulatory Affairs Services

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Data Services

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Drug Development

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Editorial and Writing Services

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Marketing, Communication & Graphic Design Services

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Process Consulting

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Drug Discovery & Development

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Clinical Research

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Seth Goldblum

Head, Business Development

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