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.

Preclinical Development

  • Pre-clinical development plans
  • Management of IND enabling studies
  • IND writing and submission
  • Pre-IND FDA meetings

Clinical Development

  • 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

Data Management

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

Pharmacology

  • Pharmacology data analysis (TK, PK, PK/PD)
  • Pharmacology modeling and simulation

SciQuus Consulting

  • Study feasibility assessments
  • Medical writing
  • Drug development plans
  • Product development/due diligence consulting
  • Pharmacovigilance
  • Medical affairs
  • Project management
  • Troubled study analysis and rescue
  • Competitor analysis

SciQuus management has extensive experience in the field of oncology clinical trials. During our careers, we have conducted trials in virtually all areas of oncologic and hematologic malignancies as well as supportive care.

SciQuus Oncology's management and scientific teams consist of highly experienced professionals who share a vision of improving the outcome for people with cancer.

Careers

No positions currently available

News / Blog

Happy Halloween from SciQuus Oncology

Happy Halloween from SciQuus’ Clinical Team: Cruella de Ville and her dalmatians!

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SciQuus Oncology will attend the 2018 American Urological Association (AUA) Meeting in San Francisco

SciQuus Oncology will be attending the American Urological Association (AUA) Meeting, May 18-21, 2018 in San Francisco. “Over the past year, we have been engaged to work on an oncology product targeting bladder cancer. As a result, we find it beneficial to interact with the larger urological community, both to identify trends in urology that […]

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Happy Holidays from SciQuus Oncology

During the holiday season more than ever, our thoughts turn gratefully to those who have made our progress possible. In this spirit, we say simply, but sincerely, thank you and best wishes for the holiday season and a Happy New Year!

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Address

4250 Executive Square, Suite 450
La Jolla, California 92037

Phone +1 (858) 642-0386
Fax +1 (858) 642-0653
Email kdorr@sciquus.com