Product Development Plan
Successful oncology drug development starts with a well thought and an intelligent development plan. This plan should be in place prior to the start of your phase 1 study.
At Phase 1 Oncology, our team of experts will help you to navigate in the ever-expanding and the competitive landscape of similar products that might already be under development by other companies.
Competitive Landscape – Identifying other companies that might be developing a product in similar indications.
Intelligent Planning – Designing a plan and an approach that separates you from your competitors.
IND Application
The most crucial step in transitioning from bench to clinical research is the regulatory approval of the Investigational New Drug (IND). As part of this application, the drug’s Investigator’s Brochure (IB) and a Clinical Study Protocol need to be submitted for assessment by the regulatory agency.
At Phase 1 Oncology, we help you with every step of this process. We review all your preclinical studies to assure that a robust IB is in place to support the IND application. We also review your proposed study protocol or produce one from scratch if needed.
Investigator’s Brochure – A robust compilation of all necessary pre-clinical studies that are needed to allow for safe transitioning of a drug from laboratory to human testing.
Clinical Study Protocol – Every clinical investigation begins with thoughtful development of a well written clinical protocol. The protocol describes how the study will be conducted (the objective(s), design, methodology, statistical considerations, etc.) and ensures the safety of the study subjects and integrity of the data that will be collected.
Site Selection / IRB Approval
Time efficiency is critical to the successful execution of every clinical study. At Phase 1 Oncology, we run several tasks in parallel. While working on the IND package, we identify and contract with Key Opinion Leaders (KOLs) and potential investigators. We assess their ability to conduct your study along with other commitments that they may have. As a result, upon approval of the study protocol by the regulatory agency, the sites can submit the protocol to their IRBs.
Identify KOLs who will champion your study along the way.
Identify Investigative Sites where your study will be successfully conducted.
CRO Selection
Conduct of a phase 1 oncology study is a tedious process, requiring adherence to a multitude of tasks and a smooth collection of clinical data. Contract Research Organizations (CROs) are the best partners to execute clinical studies according to all regulatory requirements. As another parallel task, we will identify three CROs who are best suited to execute your study. We will interview and assess their capabilities to effectively conduct and execute your study. Once a CRO is chosen, we work closely with them to assure that they conduct the study according to the protocol.
CRO Partner – To identify the best CRO partner who can execute the study.
CRO Monitoring – Working closely with CRO to assure efficient execution of the study according to the protocol.
Medical Monitoring
At Phase 1 Oncology, our seasoned US-based board-certified oncologists will monitor the day to day affairs of your study, ensuring that the trial is conducted according to the protocol and in compliance with all ethical and regulatory guidelines and requirements.
Subject Safety – Safety of the research volunteers is of utmost importance to us.
Data Analysis – Looking for safety and efficacy signals in each study subject.
Identify Trends – Analysing data on regular intervals to identify trends.
Study Report
At the conclusion of the study, our team will prepare a well-written and comprehensive clinical study report. In addition, we will provide you with our expert opinion about the next logical steps and the path for the future development of your drug.
Clinical Study Report – A thorough summary of the study findings.
Safety Report – A summary of all observed adverse events.
Recommendations – A summary of our expert recommendations including RP2D, recommended Phase 2 Dose.
Discover The Future
Our multi-disciplinary team of oncology drug development experts is ready to help you with your product.