Comprehensive services from drug development plans and facilitation INDs to clinical trial management and NDA submissions.
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.
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.
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.
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.
SciQuus provides medical monitoring services from experienced oncology clinicians. Our medical experts work closely with the site investigators to resolve any issues efficiently.
SciQuus offers expertise in PK study design and PK/PD analysis.
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.
SciQuus provides statistical support ranging from simply descriptive statistics required for interim data reports to the final analysis required for a Clinical Study Report.
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.
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.
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.
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.