Industry & CROs
We are a leading Contract Research Organization (CRO) that is designed to be an alternative to larger, conventional providers. We offer a comprehensive, personalized service portfolio that can be tailored to support preclinical research and phase 1-4 clinical trials. We provide high quality deliverables to our clients who enjoy the benefits of our proactive, specialized approach.
Disease Focused In Hematology / Oncology
We specialize in the design and conduct of hematology and oncology studies. We have expertise in many different cancer types with a special focus on multiple myeloma, breast and prostate cancers.
Our goal is to optimize the utility, efficacy and outcomes of drugs, diagnostics and the overall patient experience.
Prioritize Community Investigators & Sites
Our strategic focus is on top notch community oncology investigators and sites.
Working with community size allows us to reach a robust cohort of real-world patients for relevant, representative, and translatable outcomes.
Focused To Maintain Strategic Efficiency
Conventional CROs traditionally have inflated overheads.
In contrast, we tailor the delivery of targeted resources and services specified by our clients to optimize value and the customer experience.
Developing existing cancer treatment regimens in addition to novel promising drugs leading to improved patient outcomes
Providing community clinicians and patients with access to novel agents in development that are usually reserved for investigation by academic institutions.
Advancing the development and adoption of life-altering therapies, thereby providing new options that can extend survival and improve quality of life for patients living with cancer.
Clinical Sample Collections & Analysis
GLP compliant biobank with thousands of characterized human samples
ONCOCAPTURE = ONCOtherapeutics Collection and Archiving Program to support Research Endeavors
ONCOtherapeutics Collection and Archiving Program to Support Research Endeavors
Collaboration with GLP compliant biobank with thousands of characterized human samples
Master sample collection protocol to accommodate a multitude of different disease and tumor types
Collaboration, Consideration & Proposal
- Company Sponsored Trial (CST)
- Investigator initiated idea (ISS/IIT) identified by Onco
- CST: Industry evaluates Oncotherapeutics capabilities against other CROs
- IIT: Oncotherapeutics presents initial ISS/IIT written concept for consideration
Development Of Concept
- CST: Provides concept or protocol to review and evaluation of proposed budget
- IIT: Synopsis development and budget proposal
- CST/IIT: Review, evaluation, budget negotiations and agreement of project financial stipulations
Protocol Development, Regulatory Submissions & Project Management
- CST: Receive industry designed study for review and to provide feedback
- IIT: Full design of protocol and submission for company evaluation and approval
- CST/IIT: IRB and appropriate regulatory agency submission for approval
- Collection of documents and arrange trial master file (TMF) and EDC development
- CST/IIT: Site identification and evaluation through site qualification questionnaire
- Site selection, site budget and contracting negotiations
- CST/IIT: Ongoing study support, medical and regulatory monitoring
Recruitment, Results & Publications
- CST/IIT: Facilitate patient recruitment. Evaluation of study performance, recruitment plan and metrics
- CST/IIT: Ongoing data collection, query resolution and data review
- CST/IIT: Final data extraction, monitoring, review and analysis
- Abstract / manuscript / publication
Streamline Your Protocol Today
See how our clinical-trial services can streamline your protocol, shortening the time to move your drug from conception to regulatory and marketing approval, while dramatically reducing cost.