Bozon Biopharma Consulting
Bozon Biopharma Consulting is a leading provider in the field of clinical drug development, offering a comprehensive range of services tailored to support biopharma companies from early-stage clinical development through to market readiness. Our team of experts leverages deep industry knowledge and technical expertise to deliver effective solutions that address the complex challenges of drug development, regulatory strategy, and medical affairs.
With a focus on innovation and precision, our services encompass everything from clinical trial design and management to biostatistics, regulatory interactions, and medical affairs strategy. Whether you are preparing for an IND submission, developing clinical protocols, or engaging with key opinion leaders, Bozon Biopharma Consulting is equipped to enhance your operations and propel your projects forward.
Explore our extensive offerings to see how we can partner with you to drive success in your clinical development endeavors and achieve optimal outcomes in the competitive biopharma landscape.
Clinical Drug Development
Our comprehensive services encompass every stage of clinical development, from creating Clinical Development Plans and facilitating Pre-IND to IND filings, to providing medical strategy input and developing NDA submissions. We excel in Protocol Design, Medical Monitoring Services, and Safety Management, ensuring thorough Participant Eligibility Reviews and Integrated Data Review and Interpretation, covering safety, efficacy, and biomarkers.
We also offer extensive management of committees and boards, including Charter Development for Safety Review Committees, Independent Data Monitoring Committees, and Strategic Advisory Boards.
Our services extend to Inter-Company Joint Steering Committees, providing critical Medical Input to Regulatory Strategy. We advise on regulatory strategy, preparation, and submissions for interactions with Health Authorities, and preparing detailed Briefing Books.
Our expertise spans from Phase 1 to Phase 3, ensuring seamless progression through each phase of clinical development.
Pre-IND to IND filing
Medical strategy input and development of NDA submissions
Protocol Design
Medical Monitoring Services / Development of Medical Monitoring Plan
Safety Management
Participant Eligibility Reviews
Integrated Data Review and Interpretation (e.g.: Safety, Efficacy, biomarkers)
Coding
Management of Committees and Boards, Charter Development
Safety Review Committees Management and Charter Development
Independent Data Monitoring Committees
Strategic Advisory Boards
Inter-Company Joint Steering Committees
Medical Input to Regulatory Strategy and Interactions
Advisory services on regulatory strategy, preparation for interactions with health authorities
Meetings with Health Authorities and Sponsor
Briefing Books
Phase 1 to Phase 3
Clinical Development Team Formation
Identify and attract talent
Establish the footprint for your corporation
Medical Affairs
We can help integrate medical and scientific insights into your strategic plans, ensuring you stay ahead with cutting-edge trend analysis and strategic direction. We specialize in Key Opinion Leader (KOL) management, from identification to engagement and ongoing management of influential industry experts, based on your science, your data and the needs of your program(s).
Our Medical Science Liaison (MSL) services provide comprehensive strategies for team development, training, and maintaining regulatory compliance. Additionally, we support optimizing Medical Affairs operations through process improvements and compliance guidance, enhancing overall efficiency and effectiveness. Explore our services to see how we can elevate your medical affairs strategy:
Strategic Medical Planning Services
Integration of medical and scientific insights into strategic medical plans, focusing on emerging data, trend analysis and strategic direction.
Key Opinion Leader (KOL) Management Services
Services related to the identification, engagement, and management of key opinion leaders.
Medical Science Liaison (MSL) Services
Strategies for MSL team development, including training and compliance with regulatory standards.
Medical Affairs Operations Services
Support for optimizing Medical Affairs operations through process improvements and compliance guidance.
Business Development
We specialize in identifying and prioritizing indications to maximize your strategic growth opportunities. Our expertise extends to conducting thorough due diligence for biotech and pharmaceutical companies, ensuring informed decision-making and optimal investment outcomes. Get in touch to learn how we can support your business development goals and drive your success in the competitive biotech and pharma landscape.
Indication identification and prioritization
Biotech and pharma due diligence
Feasibility
Clinical Operations
Welcome to our Clinical Operations consulting services. We specialize in comprehensive Program Management, ensuring your clinical projects run smoothly from start to finish. Our services include meticulous Country and Site Identification and Start-Up, as well as conducting thorough Site Initiation Visits. Additionally, our Investigator Engagement Programs are designed to foster strong relationships and ensure the investigator’s commitment to the success of your clinical trials. Explore our offerings to see how we can support and enhance your clinical operations.
Program Management
Country, Site Identification and Start-Up
Site Initiation Visits
Investigator Engagement Program
Biometrics
Biostatistics and Statistical Programming
Submission-ready and audit ready data packages
SDTM / ADaM / tables, listing and figures (TLF) programming
Innovative study design
SAP and Mock tables, listing and figures
Real world data
Data Management
We offer a comprehensive suite of solutions to manage and optimize your clinical data processes. Our expertise includes External Data Management and Reconciliation, EDC Build, and CRF Design. We handle complex data flows from wearable sensors and imaging, and provide coding and ePRO solutions. Our services also cover Data Query Generation and Resolution, RTSM, and Study Metrics Reporting, ensuring accurate and efficient data management throughout your clinical trials. Explore our services to see how we can enhance the quality and reliability of your clinical data.
External data management and reconciliation
EDC built
CRF design
Wearable sensor data flow
Image data flow
Coding
ePRO
Data query generation and resolution
RTSM
Study metrics reporting