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.

News / Blog

SciQuus Oncology will attend the 2019 American Society of Clinical Oncology (ASCO) Meeting in Chicago

SciQuus Oncology will be attending the American Society of Clinical Oncology (ASCO) Meeting, May 31 – June 4, 2019 in Chicago for the sixth consecutive year. “We look forward to interacting with several of our clients at the ASCO meeting in Chicago and attending several of the plenary sessions. We always enjoy the ASCO meeting […]

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Happy Holidays from SciQuus Oncology!

With 2018 come and (almost) gone, we reflect on this busy year and those who have helped shape our business. It’s been quite a year for us all! In 2018, SciQuus grew and had a lot of fun (see photo below)! So, as we say “adieu” to 2018 and “hello” to 2019, we say thank […]

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Happy Halloween from SciQuus Oncology

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

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Address

4225 Executive Square, Suite 260
La Jolla, California 92037

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