Comprehensive services from drug development plans and facilitation INDs to clinical trial management and NDA submissions.

SciQuus Services

Project Management

SciQuus senior project managers oversee all aspects of an oncology clinical program. Project managers work closely with Sponsors to ensure that all requirements of the program are met in the most time-efficient and cost-effective manner.


  • Oversight of all aspects of a project
  • Management of project costs and timelines
  • Coordination of cross-functional teams
  • Direct project communications
  • Prospective risk assessment & management

Clinical Operations

SciQuus has developed strong relationships with numerous clinical oncology research centers with a proven track record of rapid activation, excellent clinical research staff and quality patient care.


  • Site identification, qualification & feasibility
  • Clinical site management
  • Patient recruitment and retention
  • Clinical site monitoring
  • Strong investigator and staff relationships
  • Rescue of ongoing studies

Trial Master File Management

The Trial Master File (TMF) plays a crucial role in ensuring a clinical trial has been conducted in accordance with GCP and regulatory requirements. SciQuus TMF specialists utilize best practices and the TMF Reference Model.


  • TMF set-up, maintenance and QC
  • TMF inspection readiness
  • TMF gap analysis
  • TMF remediation
  • TMF consultation

Data Management

SciQuus provides comprehensive data management services ranging from the initial clinical database design to the final database lock. Interim data can be displayed in publication-ready formats (charts, graphs, listings) as needed (BOD meetings, posters, scientific meetings) during the course of a study.


  • Clinical database design and development
  • Access to several database platforms that can be tailored to a Sponsors specific needs
  • Adherence to established data standards
  • Data collection, review and cleaning
  • Discrepancy management
  • Medical coding
  • A robust collection of reporting tools tailored to the needs of the sponsor

Medical Monitoring

SciQuus provides medical monitoring services from experienced oncology clinicians. Our medical experts work closely with the site investigators to resolve any issues efficiently.


  • Expert oncology/hematology study oversight
  • Insightful safety monitoring, assessment and reporting
  • Guidance for clinical sites and study team on study-related issues
  • Close relationships with Investigators that enhance study conduct
  • Management and chairing of Data Monitoring and Safety Review Committee meetings

PK/PD Management

SciQuus offers expertise in PK study design and PK/PD analysis.


  • Development of efficient sampling strategies for PK/PD assessment
  • Noncompartmental PK analysis
  • Correlation of PK parameters with efficacy and adverse event measures
  • Design advice for special pharmacology studies (food effect, gastric pH, drug-drug interaction)


Given the narrow therapeutic windows for many oncology drugs, pharmacovigilance is especially important in oncology. SciQuus provides expert drug safety oversight using a structured approach that results in identification of early safety signals.


  • Early detection of safety signals based on real-time evaluation of clinical safety data
  • Management of SAEs and IND safety reports
  • Study-specific safety database that assists with regulatory reporting


SciQuus provides statistical support ranging from simply descriptive statistics required for interim data reports to the final analysis required for a Clinical Study Report.


  • Descriptive statistics
  • Tables and graphs of interim clinical data
  • Statistical Analysis Plans
  • Bayesian modelling
  • ADaM and SDTM datasets


SciQuus has successfully managed numerous US FDA interactions including pre-IND, IND, type B and type C meetings. We also provide regulatory operational services for US FDA electronic submissions.


  • Regulatory strategy
  • Regulatory operations and submissions
  • Product labeling
  • Regulatory and operational risk mitigation
  • Regulatory gap analysis

Scientific and Medical Writing

SciQuus generates written materials that are succinct, easy to understand and, when required, easy to update. Well-written study documents result in faster startup, fewer protocol amendments, and fewer protocol deviations.


  • Protocols
  • Informed consents
  • Investigator brochures
  • Annual reports
  • Clinical Study Reports
  • Study manuscripts
  • Meeting abstracts, posters and presentations

Consultation Services

We offer our expertise in oncology to enhance an existing development program or as a standalone service for Sponsors exploring the oncology landscape. We can provide stand-alone consulting for any of our services.


  • CRO oversight
  • Potential clinical indications or additional indications for existing development programs
  • Due diligence for potential acquisitions
  • PK/PD analyses
  • Formation and management of Advisory Boards or Data Safety Monitoring Boards
  • Gap analyses
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what we offer

Oncology Solutions for the Biotechnology Industry

At SciQuus, we leverage our oncology expertise to drive advancements in cancer research, ensuring optimal outcomes tailored to specific project needs.