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

SciQuus Oncology will attend the 2017 American Society of Clinical Oncology (ASCO) Meeting in Chicago

SciQuus Oncology will be attending the American Society of Clinical Oncology (ASCO) Meeting, June 2-6, 2017 in Chicago for the fourth consecutive year. “As in past years, we will be interacting with several of our clients at the ASCO meeting in Chicago and attending several of the plenary sessions. We also look forward to the […]

Read full article →

SciQuus Oncology to attend the 2017 American Association of Cancer Research (AACR) Meeting in Washington, D.C.

John Gutheil, MD, CEO, and Terri Melink, NP, MSN, Vice President of Clinical Development and Operations will be attending the AACR 2017 Annual Meeting, April 1-5, in Washington, D.C. “We look forward to returning to the AACR Annual Meeting this year. As in past years, we will be interacting with several of our clients and […]

Read full article →

SciQuus runs the ZERO Prostate Cancer 5K Run/Walk in San Diego

SciQuus Oncology was thrilled to participate in the ZERO Prostate Cancer 5K Run/Walk in San Diego on September 10, 2016. The event raised over $67,000. We had a great time and look forward to participating in another race supporting cancer research in the near future. Keep an eye out for Team SciQuus! To learn more […]

Read full article →

Read more →

Address

4250 Executive Square, Suite 450
La Jolla, California 92037

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