Our Guiding Principles
Disease Management Innovation
Redefine the target disease experience by designing impactful clinical trials that can can improve outcomes with differential therapeutic attributes associated to the company’s assets.
Optimize Patient Outcomes
Establish and incorporate new therapeutic and patient management schemas into standards of care to improve drug combinations, utilization and effectiveness in support of optimal patient care.
Differentiated Service Offerings
Be disruptive in an industry ridden with conventional approaches. Be inclusive of strategic, operational and communication services that integrate the full trial experience for the client.
Deliver High Value
Establish our clinical research organization services as transformative to currently entrenched providers leading to efficiencies that impact the output and emphasize our goal of “partner of choice.”
Safety, Quality & Integrity
Commitment to the pursuit of excellence to improve clinical trial development and execution. Strive to the highest levels of integrity focusing on the safety of the patients, quality of the data, and an exceptional client experience.
Strategy
Program Strategy, Development & Optimization
Leveraging our client’s goals, ideas, and strategic plan, we provide expert guidance to support a clear pathway towards advancing and enhancing drug development programs.
Clinical Trial Concept Design & Development
Partnering with our clients to help translate a clinical study design into a protocol and a comprehensive strategy that promotes effective study conduct that can lead to improved patient outcomes.
Audit Preparation / Strategic Consulting
We offer world-class quality regulatory inspection preparedness, focusing on integrity and compliance, reducing risk, and ensuring our clients will be ready for any international or federal regulatory authority inspection.
Clinical Operations
Contract & Budget Negotiation
ONCOtherapeutics will assist with navigating the complexities and nuances of contract and budget negotiations, while maintaining fiscal responsibility and abiding by our partner’s financial objectives.
Project & Regulatory Management
Our experienced and dedicated project managers work in close collaboration with each sponsor, building meaningful relationships with study sites, performing collection and in-depth review of regulatory documents while ensuring timelines are met and adhering to budget, delivering on our promise of exceptional customer service.
Site Management
ONCOtherapeutics has extensive experience with its network of site investigators and study staff, specializing in building collaborative relationships to provide end-to-end support and guidance, and continuous recruitment motivation to meet enrollment milestones.
Safety Monitoring & Reporting
We provide comprehensive medical monitoring services for collecting DLTs and SAEs following strict safety evaluations and reporting requirements to all applicable regulatory authorities to ensure compliance, quality, and integrity.
Data Management & Analysis
EDC Design & Management
We offer a customizable, trial-specific, and efficient EDC with comprehensive data collection services via a regulatory compliant and cost-effective approach. Our approach significantly reduces database setup and deployment times developed through years of ‘hands-on’ experience.
Clinical Data Management
Our deeply experienced Clinical Research Associates (CRAs) employ a comprehensive approach to ensure studies are conducted according to protocol, maintain high data quality and integrity, comply with ICH GCP guidelines, and those of any applicable regulatory authority.
Biostatistics
ONCOtherapeutics focuses on utilizing state-of-art biostatistical methodology in providing expert, data-driven statistical analysis plans optimized for improving efficiency and resulting in cost-effective approaches to conduct clinical trials.
Medical Writing
Protocol Development
Every successful study begins with a well-designed and written protocol. Expertise inherent to ONCOtherapeutics, our scientific background, and medical writing experiences enable us to successfully and efficiently develop any complex idea from concept design to full protocol development, ensuring the highest quality and appropriate standards documentation.
Regulatory Documentation & Submission
We pride ourselves with expertise and experience in facilitating the regulatory process with expertly crafted documentation in compliance with regulatory standards for submission in eCTD format in an efficient and time-sensitive manner.
Scientific Communications
Publishing and communications are a foundational part of conducting research. We provide focused expertise in pre-clinical and clinical abstracts, posters, and peer-reviewed manuscripts that rigorously tell your compelling scientific story to its intended audience.
SOP
We offer robust, reliable medical writing services to expedite the development of high-quality SOPs with each strategy tailored to address client needs.
Streamline Your Process To Give Patients More
Let’s discuss how our comprehensive clinical study management services can streamline the execution of your clinical trial, affecting greater cost savings and expediting the development and delivery of innovative oncology treatments.