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

Clinical Research Associate (CRA)

SciQuus Oncology is seeking an experienced candidate with excellent organizational skills to join our team as a Clinical Research Associate (CRA). This position is responsible for monitoring services, ensuring quality, on-time, and cost-effective completion of studies. The CRA will interact with the clinical team, study site personnel, outside vendors, and Data Management. This position reports to the Director of Clinical Operations.

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Clinical Trial Manager

SciQuus Oncology is seeking a skilled and experienced candidate to join our clinical team at a Manager level. This position is responsible for the oversight and management of clinical trial activities, ensuring quality, on-time, and cost-effective execution of clinical trials. This position offers the opportunity to engage in all aspects of clinical trial management.

We’re looking for a highly organized and motivated individual with at least 3 years of clinical trial/operations experience (oncology experience desirable) who will interact with the clinical team, study site personnel, CRAs, outside vendors, data management, and the Finance Department.

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News / Blog

SciQuus Oncology will attend the 2016 American Society of Clinical Oncology (ASCO) Meeting in Chicago

SciQuus Oncology will be attending the American Society of Clinical Oncology (ASCO) Meeting, June 3-7, 2016 in Chicago for the third consecutive year. “As in past years, we will be interacting with several of our clients at the ASCO meeting in Chicago. We also look forward to the ASCO meeting to catch up with colleagues […]

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SciQuus Oncology to attend the 2016 American Academy of Dermatology Meeting in Washington, D.C.

John Gutheil, MD, CEO, and Terri Melink, NP, MSN, Vice President of Clinical Development will be attending the 2016 American Academy of Dermatology Meeting, March 4-8, in Washington, D.C. “We look forward to returning to the AAD meeting for the second year in a row as we continue our work on a novel Oncology product […]

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SciQuus Oncology to attend the 2015 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston

Terri Melink, NP, MSN, SciQuus Oncology’s Vice President of Clinical Development will be attending the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, November 5-9, 2015 in Boston. Terri will be meeting with several of our clients and their key opinion leaders. SciQuus strives to attend most major Oncology meetings in an effort to […]

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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